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Diagnostic Testing and Healthcare
Industry News Update
April 7 2011
In This Issue…
LabCorp Announces Definitive Agreement to Acquire Orchid Cellmark ............. 1
Abbott Gets CE Marking To Market HBV Sequencing Test In EU ........................ 2
GenMark Diagnostics Appoints Hany Massarany President and Chief
Executive Officer........................................................................................................ 3
Quest Diagnostics to Acquire Celera, Strengthening Position In Molecular
Diagnostics and Development.................................................................................. 4
BD Receives FDA Clearance for First Fully Automated Molecular Assays for
HSV1 and HSV2 from Clinician-Collected External Anogenital Lesion
Specimens .................................................................................................................. 6
Definiens and Cernostics Partner to Develop Multiplexed Cancer Diagnostic
Tests............................................................................................................................ 7
Ventana Licenses Cell Signaling’s EGFR IP and Antibodies for Tissue-Based
IVDs ............................................................................................................................. 8
QIAGEN Makes Proposal to Acquire Australian Diagnostics Company
Cellestis ...................................................................................................................... 9
Asuragen Achieves CE Mark for AmplideX Genetic Test for Fragile X
Syndrome.................................................................................................................. 11
Seegene And Molzym Partner On Automated Molecular Sepsis Diagnosis ...... 12
IRIS and Fujirebio Inc. Sign Agreement for IRIS's Hematology Analyzer
Product Line in Japan.............................................................................................. 13
Caliper Life Sciences Launches Novel COX-2 Probe to Enable Personalized
Medicine Research .................................................................................................. 14
Iris Receives FDA 510(K) Clearance For Its Automated Urine Chemistry
Analyzer and Workstation ....................................................................................... 15
Emmes News Update
Contact: [email protected]
Qiagen Readies Colorectal Cancer........................................................................ 16
Roche Acquires PVT To Strengthen Lab Automation In Clinical Diagnostics ... 16
Luminex and Partners HealthCare Announce Agreement To Collobrate On
Development of Tests ............................................................................................. 18
ARIAD And MolecularMD Announce Collaboration for a Companion
Diagnostic Test for The T315I BCR-ABL Mutation in Patients With CML .......... 19
Diagnostics: Molecular Test Offers Hope For Detecting Drug Resistance........ 21
Siemens Enhances Point-of-Care HbA1c Analyzer with Added Connectivity
and Security Functions............................................................................................ 23
Studies Evaluate A1c for Diagnosing Diabetes .................................................... 24
Emmes Now Accepting Subscriptions To Its New 2011 Molecular Diagnostics
Database................................................................................................................... 26
Emmes News Update
Contact: [email protected]
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Emmes News Update
Contact: [email protected]
Diagnostic Testing and Healthcare
Industry News Update
April 7, 2011
April 6, 2011
LabCorp Announces Definitive Agreement to Acquire
Orchid Cellmark
Laboratory Corporation of America and Orchid Cellmark an international provider of
DNA testing services primarily for forensic and family relationship applications, today
announced that they have entered into a definitive agreement and plan of merger under
which LabCorp will acquire all of the outstanding shares of Orchid Cellmark in a cash
tender offer for $2.80 per share for a total purchase price to stockholders and
optionholders of approximately $85.4 million. Orchid Cellmark strengthens LabCorp's
presence and strong brand name in identity testing in the US and establishes its
presence in identity testing in the UK.
"We are very pleased that Orchid Cellmark, a premier DNA testing business with a
strong reputation for exceptional quality, reliability and customer service is joining our
family," said David P. King, Chairman and Chief Executive Officer of LabCorp. "The
proposed acquisition of Orchid Cellmark significantly diversifies and strengthens our
specialized forensic and family relationship testing."
"The transaction underscores the fundamental value of the Orchid Cellmark business,
the talent and expertise of our global team and the quality of our testing service
offerings," said Eugene Davis, Chairman of the Board of Directors of Orchid Cellmark.
"LabCorp is a company known for bringing high quality DNA testing services to the
market making our businesses very compatible."
Following the completion of the tender offer, LabCorp expects to consummate a
merger of OCM Acquisition Corp. and Orchid Cellmark in which shares of Orchid
Cellmark that have not been purchased in the tender offer will be converted into the
right to receive the same cash price per share as paid in the tender offer.
The $85.4 million total estimated purchase price to stockholders of the transaction is
based on Orchid Cellmark's approximately 30.5 million fully diluted shares outstanding
including options with an exercise price less than $2.80 per share. Less Orchid
Cellmark's cash, cash equivalents and available for sale securities as of December 31,
2010, LabCorp's total net consideration payable is approximately $65.6 million.
Emmes News Update
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Contact: [email protected]
April 4, 2011
Abbott Gets CE Marking To Market HBV Sequencing
Test In EU
Abbott Molecular announced that it has received CE Marking (to market the Abbott
HBV Sequencing test in the European Union. This molecular diagnostic test, developed
to identify genomic sequences of the Hepatitis B Virus (HBV) and help physicians
monitor HBV infections, guide treatment decisions, and predict or discover drug
resistance, is the first DNA sequencing assay developed and introduced by Abbott
Molecular. !
The CE-Marked Abbott HBV Sequencing test identifies the DNA sequence of the HBV
polymerase gene including all clinically relevant HBV drug resistant mutations. The test
is not intended for screening blood donors, plasma or tissue donors for HBV, or to be
used as a diagnostic test to confirm the presence of HBV infection.!!
HBV is classified into eight separate genotypes (labelled A-H). HBV genotype is a
prognostic indicator because it correlates with disease severity and response to
interferon therapy. For example, genotype C is prevalent in Asia and associated with
more severe liver disease and development of liver cancer. In contrast, genotype B
(also prevalent in Asia) has a better prognosis and is rarely associated with progression
to liver cancer. Also, patients with HBV genotypes A and B seem to respond better to
interferon therapy than those with genotypes C and D.!!
Significant progress has occurred in recent years in developing antiviral therapies for
HBV. Several anti-polymerase drugs are available worldwide. The new HBV
Sequencing assay can be used in tandem with Abbott's RealTime HBV viral load assay
to monitor the efficacy of HBV treatments.!!“The addition of the Abbott HBV Sequencing
assay offers laboratories a highly precise method for managing HBV patients. After
assessing patient viral loads, physicians can order the HBV Sequencing test to select
or change antiviral therapies based on known drug resistance of specific viral
genotypes,” said Kristina Rodnikova, divisional vice president and general manager of
Abbott’s molecular diagnostics business in Europe.!!
“The Abbott RealTime HBV viral load and HBV Sequencing assays are examples of
how molecular diagnostic technologies are helping clinicians worldwide manage
serious infectious diseases more precisely and effectively through optimal utilization of
antiviral drugs.”!!
The Abbott HBV Sequencing assay was developed for use on the Life Technologies
ABI 3130 DNA sequencing system. A serious global public health problem, hepatitis B
is an inflammatory liver disease caused by the Hepatitis B Virus that results in liver cell
damage.
Emmes News Update
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Contact: [email protected]
The damage can lead to scarring of the liver (cirrhosis) and increased risk of liver
cancer.!!Hepatitis B is preventable with safe and effective vaccines that has been
available since 1982, according to the World Health Organization (WHO). But today
some two billion people has been infected with the hepatitis B virus, and more than
350 million are chronic carriers.
!In countries with a high prevalence of chronic HBV infection, the most common route
of infection is from mother to child at birth or from young children infecting each other.
In areas of low prevalence, HBV usually is transmitted during adulthood from
intravenous drug use or high-risk sexual activity.!!Abbott Molecular, is an emerging
leader in molecular diagnostics — the analysis of DNA, RNA, and proteins at the
molecular level. Some of its tests are designed to detect subtle but key changes in
human genes and chromosomes.!!Abbott is a global, broad-based health care company
devoted to the discovery, development, manufacture and marketing of
pharmaceuticals and medical products, including nutritionals, devices and diagnostics.
___________________________
April 6, 2011
GenMark Diagnostics Appoints Hany Massarany
President and Chief Executive Officer
GenMark Diagnostics, a leading provider of automated molecular diagnostic testing
systems, today announced that the Board of Directors has appointed Hany Massarany
as President and Chief Executive Officer and a member of the Board of Directors.
Since February 2009, Mr. Massarany (age 49) served as President of Ventana Medical
Systems and Head of Roche Tissue Diagnostics. From 1999 to 2009 he held various
global leadership positions with Ventana, including Chief Operating Officer, Executive
Vice President Worldwide Operations, Senior Vice President Corporate Strategy and
Development, and Vice President North American Commercial Operations. Prior to
Ventana, Mr. Massarany held executive management positions with Bayer Diagnostics
and Chiron Diagnostics, working in both Asia Pacific and the United States. He holds a
Bachelor of Science degree in Microbiology and Immunology from Monash University,
Australia and an MBA from Melbourne University, Australia.
Announcing the appointment, Christopher Gleeson, Chairman and Interim CEO of
GenMark Diagnostics, said, "Hany brings extensive experience and is a highly
regarded leader within the global diagnostics industry. He joins us at a pivotal time a
we expect GenMark to enter a period of rapid and sustained growth, and his prior
outstanding track record in high growth environments is going to be invaluable as we
seek to capitalize on the market opportunity."
Emmes News Update
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"It's a very exciting time to be joining GenMark, with the company so well positioned to
participate in the high growth molecular diagnostics market," said Massarany. "I
especially look forward to accelerating the growth of the customer base globally,
expanding the high value test menu and importantly bringing the next generation
platform to market."
GenMark, a provider of automated, multiplex molecular diagnostic testing systems,
detects and measures DNA and RNA targets to diagnose disease and to optimize the
treatment of patients and is focused on developing and commercializing its eSensor
detection technology. GenMark's XT-8 System is designed to support a broad range of
molecular diagnostic tests with a compact and easy-to-use workstation and selfcontained, disposable test cartridges. GenMark has developed five diagnostic tests for
use with the XT-8 System, including its Cystic Fibrosis Genotyping Test, Warfarin
Sensitivity Test and Thrombophilia Risk Test which have received clearance from the
Food and Drug Administration.
___________________________
March 18, 2011
Quest Diagnostics to Acquire Celera, Strengthening
Position In Molecular Diagnostics and Development
Quest Diagnostics, the world's leading provider of diagnostic testing, information and
services, and Celera Corporation one of the world's pioneers in genetic diagnostics
discovery and development, announced today that they have entered into a definitive
merger agreement under which Quest Diagnostics will acquire Celera for $8 per share,
representing a transaction value of approximately $344 million, net of $327 million in
acquired cash and short-term investments. The transaction value is expected to be
further reduced through the realization of a significant portion of Celera's available tax
credit and net operating loss carryforwards and capitalized R&D, which totaled $117
million at the end of 2010. The transaction was approved by the boards of directors of
both companies. Celera generated revenues of $128 million in 2010.
"For Quest Diagnostics, this is an important transaction which will further strengthen
our leadership position in molecular diagnostics discovery and development and drive
sustainable revenue growth. We will gain immediate access to an impressive range of
proprietary tests and products, and a strong pipeline of biomarkers for the future," said
Surya N. Mohapatra, CEO of Quest Diagnostics. "This transaction advances our
growth strategy to be the leading innovator and provider of esoteric and gene-based
testing for cancer, cardiovascular disease, infectious disease and neurological
disorders," continued Dr. Mohapatra. "I am pleased at the prospect of Celera's CEO
Kathy Ordoñez and key members of her team becoming part of Quest Diagnostics."
Emmes News Update
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Contact: [email protected]
Kathy Ordoñez, Chief Executive Officer of Celera, stated: "We are pleased to have
reached an agreement through which Celera and our Berkeley HeartLab become part
of the world's most respected diagnostic testing company. Our discovery and
validation of new biomarkers has exceeded our capacity to commercialize them.
Combining Celera's expertise in genetics with Quest Diagnostics' medical leadership,
market access and scale is expected to speed the realization of our vision to
personalize medicine. We believe this is a compelling transaction that accelerates the
delivery of value to our shareholders."
Quest Diagnostics will acquire strategic assets and capabilities through the
transaction, including:
Immediate Access to Proprietary Genetic Tests and Pipeline of Biomarkers to Drive
Sustainable Growth. Celera was founded to sequence the human genome and identify
links between genetic variations and disease states. Its renowned discovery program
has identified numerous genetic biomarkers that assess disease risk or help clinicians
select appropriate therapies for many diseases. Celera has generated a portfolio of
proprietary genetic biomarkers for numerous key clinical needs across the disease
spectrum, and has about 100 issued or pending patents. In addition, Celera's current
research and development pipeline is focused on cardiovascular disease and cancer
and is expected to produce significant value.!
Berkeley HeartLab's Unique Test Offering and Specialized Sales Force Enhances
Leading Position in Gene-based and Esoteric Cardiovascular Testing. Berkeley
HeartLab offers proprietary cardiovascular tests sold through its specialized sales force
and supported by clinical educators who provide patient disease management
services. Its leading tests include: HDL and LDL lipoprotein analysis to help
characterize a patient's cardiovascular disease risk; KIF6 genotyping test to predict
risk of coronary heart disease and response to statin therapy; 9p21 genotyping test to
predict the risk of early onset myocardial infarction; and LPA genotyping test to predict
risk of coronary heart disease and response to aspirin therapy.!
Adds Leading Genetic In Vitro Diagnostics (IVD) Products and Development Capability.
Celera develops, manufactures and commercializes test kits and reagents and is a
leading provider of molecular test products for transplantation genetics, Cystic
Fibrosis, HIV drug resistance and Fragile X syndrome.
Quest Diagnostics expects the acquisition to be dilutive to its GAAP earnings per share
by an immaterial amount in 2011, before anticipated charges related to the transaction.
The acquisition is not expected to have a material impact on Quest Diagnostics' 2012
EPS. Assuming a close of the transaction at the end of April, 2011, Quest Diagnostics
expects Celera to add just over 1% to its 2011 revenue growth.
Under the terms of the definitive merger agreement, Quest Diagnostics, through a
wholly-owned subsidiary, will promptly commence a cash tender offer to purchase all
Emmes News Update
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Contact: [email protected]
the outstanding shares of common stock of Celera for $8 per share in cash. The tender
offer is expected to be commenced within seven business days of today's date, and
will be followed by a merger, in which all the shares of Celera common stock that have
not been tendered into the tender offer will be converted into the right to receive $8 per
share in cash. The completion of the tender offer is subject to the satisfaction of
customary conditions, including that a majority of the outstanding shares of Celera
common stock (calculated on a fully-diluted basis) are tendered into the tender offer.
The transaction is subject to customary closing conditions. The transaction is not
subject to any financing condition as Quest Diagnostics has secured fully committed
bridge financing for the transaction.
___________________________
March 28, 2011
BD Receives FDA Clearance for First Fully Automated
Molecular Assays for HSV1 and HSV2 from ClinicianCollected External Anogenital Lesion Specimens
BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announced today
that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for the first
fully automated molecular tests to detect and differentiate HSV types 1 and 2 in
clinician-collected external anogenital specimens.
The new BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA
Assays (HSV Qx Assays) run on the BD Viper™ System with XTR™ Technology, which
uses Strand Displacement Amplification technology to qualitatively detect and
differentiate HSV1 and HSV2 DNA.
"HSV is a highly infectious virus that many patients do not even realize they have," said
Edward W. Hook III, Director of Infectious Disease, University of Alabama at
Birmingham Department of Medicine. "Advances in molecular testing are enhancing
our ability to identify these patients rapidly and accurately in order to treat them more
effectively and minimize their risk of spreading it to others."
"Identifying HSV patients and determining whether they have a type 1 or 2 infection is
critical to treating them effectively and preventing further spread of the disease," said
Wayne Brinster, Vice President and General Manager, Women's Health and Cancer,
BD Diagnostics. "Our new HSV tests are part of a growing portfolio of molecular
diagnostics that is designed to give clinicians better tools to manage patients who may
be suffering from a variety of the most pressing sexually transmitted infections."
Emmes News Update
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Contact: [email protected]
The new BD ProbeTec HSV Qx Assays offer excellent sensitivity and specificity and a
significant improvement in the time-to-results over culture methods, which often take
2-10 days for results. BD's new automated HSV assays also provide laboratories with
the capability to read up to 96 positive or negative results in about two and a half
hours. Using the BD Viper System with XTR Technology, laboratories also will be able
to test other samples for chlamydia and gonorrhea on the same automated run used
for the BD ProbeTec HSV1 and HSV2 Qx Assays.
The assays are not FDA cleared for use with cerebrospinal fluid (CSF) or any lesions
other than anogenital lesions. The assays are not intended to be used for prenatal
screening or for individuals under the age of 17 years.
___________________________
April 6, 2011
Definiens and Cernostics Partner to Develop
Multiplexed Cancer Diagnostic Tests
Definiens and Cernostics, a life sciences firm specializing in advanced cancer
diagnostics, today announced a partnership to develop a unique multiplexed assay
tool for the diagnosis of cancer. Cernostics will apply Definiens' image analysis
technology to develop new molecular diagnostic tests for the treatment of a variety of
cancer types.
Cernostics is using Definiens Tissue Studio™ to develop its cancer diagnostic test,
which relies on highly multiplexed panels of fluorescence biomarkers, with the final
goal to deploy the solution in the clinical routine. Definiens Tissue Studio enables
pathologists to analyze cancers on the cellular and sub-cellular level. Rapid and
accurate quantification of cancer characteristics will provide the Cernostics research
team with data on which to build and deploy cancer diagnostic tests.
Unlike some approaches that rely on single-biomarker expression, Cernostics takes a
systems approach to tumor analysis, evaluating immune, stromal, stem cell and tumor
biomarkers on a single slide while preserving tissue structure. This can help clinicians
better understand disease subtypes and help them choose the course of treatment
most suited to each patient's disease state.
"The partnership between Definiens and Cernostics will apply powerful technology to
the field of oncology diagnostics," said Thomas Heydler, CEO of Definiens. "Definiens
Tissue Studio is uniquely able to evaluate multiple channels from a single sample,
providing accurate data to support clinical decisions and help clinicians apply the best
treatment for each patient."
Emmes News Update
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"The collaboration with Definiens will enable Cernostics to accelerate development of
its pipeline of systems biology-based diagnostic, prognostic and predictive tests.
Cernostics is in a unique position to provide unsurpassed solutions for tissue analysis
and cancer diagnosis and the well validated Definiens software is a key component for
extracting precise image measurements," said Michael Hoerres, CEO of Cernostics.
To support its development of oncology diagnostic technology, Cernostics is working
closely with Geisinger Health System, a $2.3 billion integrated health services
organization based in Pennsylvania. Supported by Geisinger, Cernostics gains access
to a clinical setting on which to create and validate pathology solutions, including a
large tumor bank linked to well-annotated, deep and longitudinal clinical information.
Definiens is a leading Health Image Intelligence™ company that develops software
solutions for biomedical image analysis, data mining and clinical decision support. The
company's software analyzes images from cell-based assays, whole tissue slides and
full body scans and allows users to correlate this information with data derived from
other sources, supporting better decisions in research, diagnostics and therapy. By
automating analysis workflows and generating new knowledge, Definiens provides
pharmaceutical and biotechnology companies, research institutions, clinical service
organizations and medical professionals with deeper insights, faster results and better
decision support. Harnessing the power of image intelligence, Definiens supports
personalized medicine and aims to significantly improve the quality of patients' lives.
Definiens is headquartered in Munich, Germany, and has offices throughout the US.
___________________________
April 1, 2011
Ventana Licenses Cell Signaling’s EGFR IP and
Antibodies for Tissue-Based IVDs
Ventana Medical Systems negotiated a nonexclusive worldwide license to relevant Cell
Signaling Technology (CST) IP and antibody reagents for the detection of epidermal
growth factor receptor (EGFR) mutations in the field of tissue-based in vitro diagnostic
testing. CST says it has already developed mutation-specific EGFR antibodies through
its in-house cancer biomarker program. “CST is very excited to enter into this
agreement with Ventana for the development of next-generation diagnostic products
that intend to fulfill the promise of personalized cancer medicine,” remarks Michael J.
Comb, Ph.D., CST’s president and CEO.!
Ventana is owned by Roche and specializes in the development medical diagnostic
systems and slide-based tests for cancer. Marketed products include the Vantage
Workflow Solution and associated slide stainers, image-analysis solutions, and a rabbit
monoclonal breast panel.!
Emmes News Update
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Contact: [email protected]
CST is focused on developing research tools used to help define mechanisms
underlying cell function and disease, and in particular the production of the activationstate antibodies for investigating cell signaling pathways.!
Just last month the firm announced a joint cancer therapeutics and diagnostics
partnership with Astellas Pharma that aims to commercialize diagnostic and
therapeutic products targeting the cancer enzyme EML4-ALK. The project will build on
CST’s discovery of certain variants of EML4-ALK in human cancer, and subsequent
development of clinically validated antibodies that can detect the enzyme in human
cancer tissues.
___________________________
April 4, 2011
QIAGEN Makes Proposal to Acquire Australian
Diagnostics Company Cellestis Limited
QIAGEN has reached an agreement to acquire Cellestis Limited (CST: AU) for
approximately A$341 million (US$355 million) in cash, providing QIAGEN with access
to a novel "pre-molecular" technology that offers a new dimension in disease detection
not currently possible with other diagnostic methods.
The acquisition of Cellestis, a publicly listed, profitable company headquartered in
Australia, will provide QIAGEN with exclusive rights to QuantiFERON® technology, a
proprietary approach for disease detection and monitoring.
Cellestis has successfully commercialized this technology with QuantiFERON®-TB
Gold In-Tube (QFT), a leading test for latent tuberculosis (TB), and is in the early stages
of commercializing QuantiFERON®-CMV for monitoring of disease risk from the lifethreatening cytomegalovirus (CMV). These tests are approved and commercialized in
various countries and are believed to have significant untapped market potential.
QuantiFERON® is a patent-protected platform technology that can provide information
on diseases far earlier than possible with other diagnostic methods. QuantiFERON®
tests whole blood samples for the presence of systemically amplified molecular
analytes which provide information from the immune system's memory.
Based on its ability to provide diagnostic information far earlier than DNA-based
molecular tests, QuantiFERON® is considered a "pre-molecular" testing technology.
As a result, tests based on QuantiFERON® can even provide critical information on
latent infections, where pathogens (bacteria, viruses, fungi) are present in such low
amounts that they are not detectable with traditional DNA-based molecular Dx.
Emmes News Update
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Contact: [email protected]
QuantiFERON® is complementary to QIAGEN's portfolio of molecular diagnostics. Its
high sensitivity and ability to provide clinically relevant information means that this
technology can be used ahead of DNA- or RNA-based molecular testing. Greater use
of QuantiFERON® technology can help guide and drive the use of traditional DNA- and
RNA-based molecular diagnostics. For example, patients identified through
QuantiFERON®-based tests to be at risk for certain diseases could then proceed for
subsequent testing or increased monitoring with corresponding DNA- or RNA-based
molecular diagnostics to assess disease activity levels and guide treatment decisions.
"We believe next-generation DNA- and RNA-based molecular testing can benefit from
greater use of QuantiFERON® technology, which has a unique ability to identify
patients at risk from potentially life-threatening diseases. The power of QuantiFERON®
can help save lives by enabling medical treatment through earlier, deeper and much
more sensitive disease detection than previously possible," said Peer Schatz, Chief
Executive Officer of QIAGEN N.V.
"Cellestis has developed a technology that is highly complementary to our portfolio
and which we expect to migrate onto our QIAsymphony, QIAensemble and our point of
need platforms, thereby adding a new, unique assay menu to these QIAGEN platforms.
We believe the addition of Cellestis will further strengthen our capabilities to offer
innovative sample and assay technologies that are making improvements in life
possible."
"Cellestis has succeeded in developing QuantiFERON® as a breakthrough technology,
via the QFT-TB test that is becoming the standard for latent TB diagnosis," said
Cellestis CEO Anthony Radford.
"We believe QIAGEN as an industry-leading company provides the best strategic fit in
terms of capabilities and resources. As part of QIAGEN, we will be able to accelerate
our growth much faster than as a stand-alone company and offer even greater benefits
to patients and healthcare providers."
Following successful completion of the transaction, QIAGEN plans to migrate
QuantiFERON® onto QIAensemble, a next-generation high-throughput automation
system in development and nearing market entry; QIAsymphony, a highly versatile
automation system for low- to mid-throughput volumes available around the world; and
QIAGEN's point of need testing platforms acquired from ESE GmbH.
___________________________
Emmes News Update
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Contact: [email protected]
March 23, 2011
Asuragen Achieves CE Mark for AmplideX Genetic
Test for Fragile X Syndrome
Asuragen has commercially launched its AmplideX™ fragile x test in Europe on the
back of CE-mark approval. The FMR1 PCR Kit has been developed to detect CGG
repeats in the fragile X mental retardation (FMR1) gene, and can be used to aid in the
diagnosis of associated disorders including fragile X-associated primary ovarian
insufficiency, and fragile X-associated tremor/ataxia syndrome. Asuragen claims the
assay can help reduce the need for Southern blot testing by some 98%.
!The AmplideX test will be available through Asuragen’s recently established network of
European distributors. “Our distribution partners will also serve a critical role in
accelerating clinical validation and CE-marking of our portfolio of molecular diagnostic
products,” notes Rollie Carlson, Ph.D., Asuragen president.!
Molecular diagnostics company Asuragen is exploiting its specialist mRNA and miRNA
expertise to develop oncology and companion diagnostic tests, and also offers RNA
stabilization technologies, and controls and standards engineered using its Armored
RNA® technology.
!The firm’s Signature® range of oncology tests includes the Signature LTx v2.0 test, for
the detection and identification of fusion transcripts from common chromosome
translocations and abnormalities associated with CML, ALL, APL, and AML. The
Signature NPM1 Mutations (RUO) test is designed to simultaneously detect the most
common exon 12 nucleophosmin (NPM1) gene mutations in AML. The Signature
KRAS/BRAF Mutations assay is a research tool for detecting KRAS and BRAF cancer
mutations in genomic DNA extracted from human cell lines or fresh, frozen or fixed
tissues.!
Asuragen also operates a pharmacogenomic services division that provides nucleic
acid-based services, including analyte isolation/preparation from multiple sample
types, genomic profiling, miRNA/mRNA expression profiling, biomarker discovery,
assay design, and validation, CLIA-based clinical testing, bioinformatics, and
regulatory and project management services. Asuragen also offers a full range of
contract RNA manufacturing services and GMP contract manufacturing for in vitro
synthesized RNA for use in vaccines.
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Emmes News Update
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Contact: [email protected]
March 24, 2011
Seegene And Molzym Partner On Automated
Molecular Sepsis Diagnostics
Seegene and Molzym today announced a partnership on the automated Magicplex™
Sepsis, a new multi-pathogen screening test capable of quick and accurate
identification of over 90 leading sepsis-causing pathogens. Magicplex Sepsis provides
a novel and fast-acting diagnostic technique for hospitals to simultaneously verify a
complex range of targets that indicate sepsis, the leading cause of death in noncoronary intensive care units worldwide. Seegene’s automated Magicplex Sepsis will
be introduced at the 2011 Congress of the European Society of Clinical Microbiology
and Infectious Diseases (ECCMID, 7 -10 May 2011) in Milan, Italy.!
Sepsis is a deadly disease that leaves no clear track back to initial indications, which
could include gram-positive bacteria, gram-negative bacteria or fungi. The results are
devastating: the annual incidence rate of sepsis has increased 91.3 percent over the
last 10 years, and every hour 25 people in the United States die from severe sepsis.
One of every three patients who develop severe sepsis will die within a month. Severe
sepsis, the leading cause of death in the non-coronary intensive care unit, takes more
lives than breast, colorectal, pancreatic, and prostate cancers combined.!
The Magicplex Sepsis Test simultaneously screens for over 90 sepsis-causing
pathogens: 73 Gram (+), 12 Gram (-), 6 fungi, and 3 antibiotic resistant genes can also
be discriminated. The Magicplex Sepsis Test requires 1ml of patient’s whole blood and
provides test results within three hours (after extraction). The microbial DNA
enrichment is based on Molzym”s MolYsis technology enabling up to 40,000-fold DNA
enrichment over conventional technologies. Automated DNA isolation is performed
with Seegene”s Seeprep12 instrument based on Nordiag”s “Arrow” system.!
“The Magicplex Sepsis Test will be the new gold standard for performing accurate,
rapid and cost-effective sepsis diagnosis,” said Dr. Jong-Yoon Chun, chief executive
officer of Seegene. “In treating sepsis, time and accuracy are demanded. Every hour of
delay in giving patients the correct antibiotics results in an 8% increase in the mortality
rate.”!“The automation reduces the total process costs significantly and makes
Magicplex Sepsis Test the first true routine sepsis test worldwide” says Prof. Dr.
Michael Lorenz, Chief Scientific Officer at Molzym.!
Magicplex Sepsis Test is based on Seegene’s proprietary READ™ technology, which
combines the advantages of multiplex Real-Time PCR system. The result is a
molecular diagnostic test system that provides higher specificity and sensitivity over
currently available PCR systems.
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Emmes News Update
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Contact: [email protected]
April 4, 2011
IRIS and Fujirebio Inc. Sign Agreement for IRIS's
Hematology Analyzer Product Line in Japan
IRIS, aleading manufacturer of automated in-vitro diagnostics systems and
consumables, and a provider of high value personalized diagnostics testing services
through its CLIA certified molecular diagnostics laboratory, announced today that it
has entered into a Joint Development Agreement with Fujirebio Inc., one of the largest
in vitro diagnostics companies in Japan, for the co-development of the IRIS
3GEMS(TM) Hematology Analyzer product line.
Terms of the agreement call for Fujirebio to contribute $6 million toward the costs of
the Joint Development Program, with an initial payment of $500,000 upon signing of
the agreement and the balance to be paid in installments during the course of the
development period based upon the achievement of certain milestones.
These funds will be utilized to accelerate the 3GEMs Hematology development
program, which leverages IRIS's proprietary image-based technology to automate the
identification and characterization of blood cells, including an image-based expanded
white blood cell differential, and is expected to significantly reduce the need for manual
slide preparation and reviews.
"We are delighted with this expansion of our relationship with Fujirebio, which is
currently our exclusive distributor in Japan for IRIS's series of Automated Urine
Microscopy and Chemistry Analyzers," stated Cesar García, Chairman, President and
Chief Executive Officer of IRIS International.
"The extension into hematology of IRIS's core expertise in automated flow imaging
technology and particle recognition represents a significant opportunity and we are
pleased that Fujirebio has committed to partnering with us."
Headquartered in Tokyo, Japan, Fujirebio Inc., a company of Miraca Holdings, is a
leading in vitro diagnostics (IVD) company specializing in the development,
manufacturing and commercialization of IVD products.
Fujirebio has achieved worldwide recognition for its achievements in
immunodiagnostics, particularly for infectious diseases and cancer. The Company
provides IVD assay reagents and a series of fully automated analyzers, including its
LUMIPULSE system based on chemiluminescent enzyme immunoassay, in Japan.
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Emmes News Update
13
Contact: [email protected]
April 4, 2011
Caliper Life Sciences Launches Novel COX-2 Probe to
Enable Personalized Medicine Research
Caliper Life Sciences, today announced the launch of XenoLight(TM) RediJect(TM)
COX-2 Probe (Fluorocoxibs), a novel fluorescent imaging agent for pre-clinical
research that specifically detects the cyclooxygenase-2 (COX-2) biomarker
noninvasively in live animal models as well as in ex vivo tissue analysis applications.
The COX-2 fluorescent probe technology was invented at the research laboratory of
Dr. Lawrence Marnett at Vanderbilt University and is licensed to Caliper.
"COX-2 is over-expressed in a variety of inflammatory and neoplastic diseases. The
opportunity to non-invasively image COX-2 offers promise for both the early detection
of disease and monitoring therapeutic response. The fluorocoxib probe should be
valuable to investigators in multiple disciplines, including cancer research," said
Professor Andrew Dannenberg, Director of Cancer Center at Weill Cornell Medical
College, a research leader in the field of COX-2 in oncology and inflammation.
Researchers can gain an understanding of therapeutic efficacy in specific patient
populations by monitoring key biomarker response to a drug treatment. These findings
then help tailor patient-specific therapeutic strategies to improve outcomes and
advance the scope of personalized medicine. For example, COX-2 detection in tumors
has become an important tool in predicting the outcome of various chemotherapy
treatments, including advanced lung cancer. Caliper's RediJect COX-2 probe provides
the ability to non-invasively detect COX-2 in early-stage cancer cells, with a level of
sensitivity and accuracy not attainable by conventional methods.
"Personalized therapies to treat specific patient populations are becoming reality," said
Kevin Hrusovsky, President and CEO of Caliper Life Sciences. "Our partnership with
Professor Lawrence Marnett, the inventor of the COX-2 probe and a prolific author and
thought leader in the field, will further catalyze research in biomarker response, helping
to provide insight into the development of new or rescued targeted therapies. Caliper
remains committed to providing translational research technology and services
focused on further realizing the full potential of personalized medicine."
The RediJect COX-2 probe is the latest in an expanding range of reagents for Caliper's
IVIS® and Maestro® optical imaging systems, and our Trio(TM), Nuance® and
Vectra® tissue analysis systems. Caliper's portfolio of industry-leading pre-clinical
imaging technology complements an expansive range of imaging reagents optimized
to enable researchers to monitor various biological events, in live models and in
excised tissue samples. Caliper offers a variety of fluorescent and bioluminescent
reagents that can be applied in a range of therapeutic areas, including oncology,
infectious diseases, inflammation, neurology and stem cell research.
Emmes News Update
14
Contact: [email protected]
March 24, 2011
Iris Receives FDA 510(K) Clearance For Its Automated
Urine Chemistry Analyzer and Workstation
IRIS, a leading manufacturer of automated in-vitro diagnostics systems and
consumables for use in hospitals and commercial laboratories worldwide, and a
provider of high value personalized diagnostics testing services through its CLIA
certified molecular diagnostics laboratory, announced today that its Iris Diagnostics
Division has been granted 510(k) clearance from the U.S. Food and Drug
Administration (FDA) to market its iChem®VELOCITY™ Automated Urine Chemistry
Analyzer and iRICELL® Urinalysis Workstation.
"We are delighted to receive this clearance which represents a major milestone for IRIS
and is the culmination of a challenging regulatory review process. We are now poised
to immediately commence the launch of iChemVELOCITY in the U.S., as well as in
those countries which require regulatory approval in the country of origin. This is
expected to result in gross margin improvement and greater profitability for our core
urinalysis business in 2011 and beyond, and will significantly increase the pull-through
of iChem test strips benefiting the utilization of our strip manufacturing facility in
Marburg, Germany, which is already operating near breakeven," stated Cesar Garcia,
Chairman, President and CEO of IRIS International.
"As the worldwide market leader in automated urinalysis microscopy, FDA clearance of
the iChemVELOCITY represents a critical element in our strategy to provide both a
stand alone automated urine chemistry analyzer and the iRICELL fully integrated
urinalysis workstation globally. This gives us the opportunity to gain full access to and
further penetrate the balance of the estimated $500 million worldwide urine chemistry
market with improved gross margin through economies of scale," stated Thomas
Warekois, President of the Diagnostics Division. "The iChemVELOCITY automated
urine chemistry analyzer, combined with our series of leading iQ®200 automated urine
microscopy analyzers, forms our portfolio of iRICELL Urinalysis Workstations,
significantly enhancing and rounding out our core urinalysis business. We are now in a
position to expand our market share by offering customers in the U.S. and globally, a
fully integrated, bench top automated urinalysis solution under one platform," he
added.
While pursuing U.S. regulatory clearance, IRIS received CE Mark certification and
launched the iChemVELOCITY to the international marketplace in September 2008,
and since that time has sold more than 300 instruments in more than 30 countries.
The iChemVELOCITY system is designed to deliver improved productivity and clinical
utility in the medium to high volume hospital and clinical reference labs.
___________________________
Emmes News Update
15
Contact: [email protected]
March 1, 2011
Qiagen Readies Colorectal Cancer Test
Qiagen inked a deal with Epigenomics that will prepare the company to launch a
molecular diagnostic test in the high growth colorectal cancer screening market. This
could be a challenge for nascent companies such as Exact Sciences and others that
are working to develop colorectal cancer tests.
Analysis
Qiagen and Epigenomics are teaming up to develop and launch a molecular
diagnostics test for colorectal cancer on Qiagen's QIAsymphony system. The National
Cancer Institute estimates there will be about 142,000 new cases of colorectal cancer
diagnosed in 2010 and that more than 51,000 people will die from colon and rectal
cancer this year. The American Cancer Society recommends that all Americans start
getting tested for the disease at age 50. However, many patients do not comply fully
with current screening recommendations. In fact, 60 percent of patients today are
diagnosed with colorectal cancer in the late stages, primarily because of poor
screening compliance. The potential market for a non-invasive colorectal cancer test is
obviously large, with several estimates over $1 billion.
A key aspect of the Qiagen/Epigenomics deal is the Septin 9 colorectal cancer marker
sample preparation technology. Those that follow the high growth molecular
diagnostics market know that there is a very serious shortage of qualified accredited
medical technologists that are able to run complex molecular diagnostics
assays. Qiagen's deal is yet another attempt to address the problem. Competitors in
the Septin 9 market include Abbott, ARUP labs, and Quest Diagnostics.
___________________________
March 15, 2011
Roche Acquires PVT To Strengthen Lab Automation In
Clinical Diagnostics
Roche announced today the acquisition of PVT Probenverteiltechnik GmbH based in
Waiblingen, Germany and of PVT Lab Systems, LLC based in Atlanta, Georgia, USA.
PVT is a global market leader in providing customised automation and workflow
solutions for in-vitro diagnostic (IVD) testing in large commercial and hospital
laboratories. Under the terms of the agreement, Roche will pay PVT shareholders an
upfront payment of EUR 65 million as well as up to EUR 20 million upon reaching
performance-related milestones. The transaction is subject to customary closing
conditions. PVT will become one of the competence centers inside Roche for the
development and manufacturing of automation products.
Emmes News Update
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Contact: [email protected]
The acquisition will expand Roche’s global access to PVT’s product portfolio for
automation of pre- and post-analytical tasks such as centrifuging, pipetting, sorting
and archiving across a large variety of sample formats. Through optimized work
processes, improved turn-around-times as well as increased quality and security of
sample handling, PVT’s products enable clinical laboratories to reliably manage low to
very high sample volumes and to arrange their lab space with great flexibility.
“Increasing laboratory consolidation leading to testing volumes of tens of thousands
samples per day demand an ever-higher degree of automation,” said Daniel O’Day,
COO of Roche Diagnostics. “With PVT’s technology we will be able to deliver
integrated and highly-efficient automation solutions to meet the evolving needs of our
customers and further strengthen our leading position in the clinical diagnostics
market.”
The newly acquired automation capabilities will strengthen Roche’s growth and
competitive advantage in the laboratory core business, which had an estimated market
size of USD 15.3 billion in 2009. By combining its integrated, modular and highly
efficient analyzers, like the cobas 6000 analyzer for medium-sized labs or the cobas
8000 analyzer for large-volume labs, either with the MODULAR PRE-ANALYTICS
(MPA) systems or with PVT’s front- and back-end automation solutions, Roche is able
to customise its offer for all different types and sizes of clinical laboratories.
PVT and Roche have had a close partnership for over fifteen years, under which Roche
has been distributing PVT products, such as the RSA Pro and the RSD Pro system, in
Europe, Asia and Latin America.
“Our trusted and long-term collaboration has been key in our growing success,” said
Michael Ziegler, CEO and co-founder of PVT. “Roche is the ideal company to deliver
the next generation of laboratory automation systems. We’re very committed to the
continued success and support of PVT’s employees, products and pipeline.”
“We will further develop customized automation solutions that complement and
enhance our entire laboratory analytics instrument portfolio, which we expect will boost
sales across our entire core business,” stated Colin Brown, Head of Roche
Professional Diagnostics.
“With this acquisition, we gain a very talented group of people with strong expertise
and domain knowledge, which we expect to be instrumental in meeting our customers’
demands.”
___________________________
Emmes News Update
17
Contact: [email protected]
February 15, 2011
Luminex and Partners HealthCare Announce
Agreement To Collobrate On Development of Tests
Luminex Corporation announced today that it has teamed with Partners HealthCare
toward the discovery of novel biomarkers and development of clinical assays. This
program will enable Partners HealthCare Center for Personalized Genetic Medicine
(PCPGM) to develop novel molecular diagnostic assays based on biomarkers
discovered within Partners HealthCare entities. These innovative tests will operate on
Luminex's proprietary xMAP® testing platform. Under the terms of the agreement,
Luminex and PCPGM will evaluate opportunities for novel assays which will be
developed and validated in the PCPGM's CLIA-certified Laboratory for Molecular
Medicine.
"The collaboration with Luminex represents an important step forward in furthering
Partners HealthCare Center for Personalized Genetic Medicine's mission to bridge the
gap between research and clinical medicine," said Dr. Heidi Rehm, Director of
PCPGM's Laboratory for Molecular Medicine at Partners HealthCare. "Luminex's
xMAP technology provides an ideal platform for Partners HealthCare to translate novel
biomarker discoveries into cutting-edge tests and accelerate adoption of new
molecular tests to provide the best clinical care for patients."
The strength of the relationship between Luminex and PCPGM is the resources,
technologies and industry experience that each organization offers, from research,
development and the ability to commercialize novel molecular diagnostic assays. By
utilizing Luminex's xMAP technology, PCPGM can develop novel assays and bring
them from discovery to clinical diagnostics more efficiently and cost-effectively.
"Luminex and Partners HealthCare have a shared commitment to leverage genetic
testing and personalized medicine to improve the quality of care and treatment for
patients," said Patrick J. Balthrop, president and CEO of Luminex. "Partners
HealthCare is a premier institution with a history of proven success in the field of
molecular diagnostics, and through the Center of Excellence agreement, we are
confident that our joint efforts will drive market innovation and important technology
advancements that will help dramatically improve patients' lives in the years ahead."
Partners HealthCare is an integrated health system founded by Brigham and Women’s
Hospital and Massachusetts General Hospital. In addition to its two academic medical
centers, the Partners system includes community and specialty hospitals, community
health centers, a physician network, home health and long-term care services, and
other health-related entities. Partners is one of the nation’s leading biomedical
research organizations and a principal teaching affiliate of Harvard Medical School.
Emmes News Update
18
Contact: [email protected]
Luminex Corporation develops, manufactures, and markets proprietary biological
testing technologies with applications throughout the diagnostic and life sciences
industries. The company's xMAP® multiplex solutions include an open-architecture,
multi-analyte technology platform that delivers fast, accurate, and cost-effective
bioassay results to markets as diverse as pharmaceutical drug discovery, clinical
diagnostics, and biomedical research, including the genomics and proteomics
markets. The company's xMAP Technology is sold worldwide and is already in use in
leading clinical laboratories, as well as major pharmaceutical, diagnostic, and
biotechnology companies.
___________________________
March 28, 2011
ARIAD And MolecularMD Announce Collaboration for
a Companion Diagnostic Test for The T315I BCR-ABL
Mutation in Patients With CML
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) and MolecularMD Corporation today
announced an exclusive collaboration agreement in which MolecularMD will develop
and commercialize a companion diagnostic test to identify the T315I mutation of the
BCR-ABL gene in patients with chronic myeloid leukemia (CML) and Philadelphia
positive (Ph+) acute lymphoblastic leukemia (ALL).
“We believe that MolecularMD has more experience with T315I mutation assays than
any other laboratory in the world”
ARIAD is advancing its investigational, pan-BCR-ABL inhibitor, ponatinib, in the pivotal
PACE trial of patients with resistant or intolerant CML and Ph+ ALL, or those with the
T315I mutation. MolecularMD has performed BCR-ABL mutation testing with its
standardized and validated sequencing test in patients enrolled in ARIAD’s earlier
Phase 1 trial of ponatinib and now is conducting similar testing prior to patient
treatment in the PACE trial.
As part of this collaboration agreement, MolecularMD will further optimize its currently
available sequencing test and will file a Premarket Approval Application (PMA) with the
U.S. Food and Drug Administration to support commercialization of the diagnostic test.
The companies expect MolecularMD to submit the PMA at approximately the same
time as ARIAD files its New Drug Application (NDA) for ponatinib in 2012. MolecularMD
will also seek a CE Mark for a companion diagnostic test kit in Europe. Once approved,
MolecularMD will have responsibility for commercializing the T315I diagnostic test.
Emmes News Update
19
Contact: [email protected]
MolecularMD’s expertise in BCR-ABL mutation testing stems, in part, from the
pioneering research and intellectual property of its scientific founder, Dr. Brian Druker,
director of the Oregon Health & Science University (OHSU) Knight Cancer Institute,
Howard Hughes Medical Institute Investigator, and JELD-WEN Chair of Leukemia
Research at OHSU. Dr. Druker also has been a long-standing scientific and medical
collaborator of ARIAD in the development of ponatinib.
“We believe that MolecularMD has more experience with T315I mutation assays than
any other laboratory in the world,” stated Timothy P. Clackson, Ph.D., president of
research and development and chief scientific officer at ARIAD. “We are pleased to
extend our highly productive collaboration with MolecularMD and look forward to
working together on the development of a commercial test for the detection of the
T315I mutation.”
“MolecularMD was founded with the goal of offering clinically relevant molecular
testing in the age of targeted cancer therapies,” commented Stephane Wong, Ph.D.,
M.B.A., chief scientific officer of MolecularMD.
“We have been working with ARIAD throughout ponatinib’s clinical development and
share in the excitement over the drug’s activity in resistant and intolerant CML patients
and those with the T315I mutation for whom current therapies are ineffective. We are
pleased to be advancing our partnership with ARIAD, and we look forward to
commercializing our T315I test as a companion diagnostic to ponatinib.”
Under terms of the collaboration agreement, ARIAD will reimburse MolecularMD for
predefined expenses for the development of the T315I diagnostic test. ARIAD will also
pay MolecularMD milestones for achievement of key development and regulatory
activities.
The MolecularMD companion diagnostic test is being developed to identify CML and
Ph+ ALL patients who have the T315I mutation. A companion diagnostic test is not
necessary to support the broader potential use of ponatinib in patients who are
resistant or intolerant to the current second-generation BCR-ABL inhibitors, as being
studied in the PACE trial. Many mutations in addition to T315I account for resistance to
currently marketed BCR-ABL inhibitors.
___________________________
Emmes News Update
20
Contact: [email protected]
March 28, 2011
Diagnostics: Molecular Test Offers Hope For
Detecting Drug Resistance
For more than 100 years, the world has been relying on the same basic technology to
detect tuberculosis: a smear test from sputum that is peered at through a microscope.
But a few months ago, the World Health Organization (WHO) endorsed an automated
molecular test (Xpert MTB/RIF) that many hope will revolutionise the detection of this
killer disease, especially for strains of multi-drug resistant TB (MDR-TB) and TB in
those living with HIV.
The most important advantage of this test over the usual smear is its greater reliability
in identifying TB cases, otherwise known as the sensitivity rate.
In studies, the WHO says the sensitivity of the “Xpert” test was 91 per cent, compared
with 59.5 for the standard smear test.
The test’s sensitivity to TB that is resistant to an important antibiotic – Rifampicin – was
95.1 per cent. Ordinary smears cannot detect antibiotic resistance. It can also help to
diagnose cases of TB that coexist with HIV, which may be missed in smear tests.
The gold standard for detecting TB remains the culture of the mycobacterium that
causes the disease, but this has drawbacks: it takes many weeks to grow the culture
and it requires expensive infrastructure, with laboratories and technicians, which are
scarce in poorer countries.
Xpert, on the other hand, can be used in more basic labs because it is simpler and
safer to use and results are available in a couple of hours.
This is particularly important for MDR-TB, a disease that is of extreme concern to
public health officials because it is so hard to treat.
Gilles Van Cutsem, medical co-ordinator for the charity Médecins sans Frontières for
South Africa and Lesotho, says: “If you don’t test for MDR-TB, you don’t find it. It’s the
hidden epidemic. But where you test, you find it in very high numbers ... Survival
improves when you test, because you can start early treatment and you can treat in
local clinics. Also, just as important, early diagnosis cuts transmission. It’s the key to
decreasing the epidemic.”
Typically, this dangerous form of TB is diagnosed from culture only after treatment with
first line antibiotics fails.
Emmes News Update
21
Contact: [email protected]
As Karin Weyer, co-ordinator at the WHO’s Stop TB Department, explains: “To
diagnose MDR-TB, you have to rely on expensive tests that are only available at
reference labs nationally. Today, less than 10 per cent of MDR-TB patients are tested
The sooner you can start treating patients with MDR-TB, the more lives you will save.
[It] is spreading fast in vulnerable populations, such as those with HIV co-infection,
who die prematurely, often before the diagnosis of MDR-TB is made.” The WHO
believes the new test could lead to a threefold increase in the diagnosis of patients
with MDR-TB and a doubling for HIV-associated TB in areas where there are high rates
of HIV.
More than 20 countries have received the new test, according to the Foundation for
Innovative New Diagnostics (Find), one of Xpert’s developers. Its advocacy officer,
Lakshmi Sundaram says uptake will partly depend on how “flexible and proactive”
large donors are.
For all the excitement, Xpert is not the perfect diagnostic test – one that can be
cheaply and reliably performed anywhere (like the urine dipstick test for diabetes or
pregnancy).
The test machines require a regular power supply. They need to be calibrated each
year and require some training. Also they do not come cheap.
Even after big discounts – more than 60 per cent – for low and middle-income
countries, the device will cost roughly $17,000. This is much more than the $1,500 cost
of a microscope, though much less than that of equipping a lab for culture according
to the WHO.
The costs per test will range from $10.72 to $16.86 depending on volumes, roughly
comparable – at the low end – to the cost of repeating a smear test several times, as is
often done.
The WHO has recommended that Xpert be used as the initial test where patients are
suspected to have MDR-TB or HIV-associated TB.
In other cases, microscopy will remain the mainstay.According to Dr Van Cutsem, cost
is an important constraint. “The price ... needs to be reduced for scale-up to be
possible. It is the main barrier at the moment. The situation where there’s only one
manufacturer for a diagnostic test that has the potential for an enormous public health
impact ... is not optimal and the emergence of generic competition is highly desirable,”
he says.
Developments such as cheaper power supplies and remote calibration would improve
the situation. There is also research into whether the devices could be used to run
other tests, such the viral load in HIV cases.
Emmes News Update
22
Contact: [email protected]
At the Global Fund to fight Aids, Tuberculosis and Malaria, Mohamed Abdel Aziz,
senior TB adviser, sums up the importance of this new technology: “This is a big step
forward, but it is not the end of a long route to discover a diagnostic tool that is
available everywhere ... This test will not replace microscopy.”
___________________________
March 24, 2011
Siemens Enhances Point-of-Care HbA1c Analyzer with
Added Connectivity and Security Functions
Siemens Healthcare Diagnostics today announced a new enhanced version of its DCA
Vantage Analyzer, a point-of-care (POC) immunoassay analyzer for diabetes
management. The system now provides enhanced operator management and
connectivity capabilities to meet the growing demands in POC testing for improved
compliance management and data capture into patient records. The DCA Vantage
Analyzer with Version 3.0 Software has the capacity to manage a larger number of
operators while providing the required security access modes to prevent unauthorized
use. In addition, the analyzer is one of the first hemoglobin A1c (HbA1c) POC analyzers
in the industry to include the POCT1-A2 communication protocol. Use of this standard
interface simplifies the connection to POC data management systems, enabling results
to be automatically transmitted to the patient electronic medical record.
The rising number of hospital-owned or affiliated physician offices and clinics is driving
the need for advanced security features and flexible connectivity options in POC
testing devices. One of the biggest challenges for point-of-care managers in hospitals
and large clinics is the management of multiple POC analyzers and operators to ensure
compliance with applicable regulations and requirements. In addition, POC managers
are demanding better connectivity between their POC analyzers and the associated
healthcare organization so test results can be automatically transmitted to the
laboratory and hospital information systems, and eventually to the patient’s electronic
medical record.
The DCA Vantage Analyzer ensures that all analyzers are running the same quality
control regimen required by their institution and that only authorized operators are
running the devices according to their specified access level. The operator
management capability has been expanded
___________________________
Emmes News Update
23
Contact: [email protected]
March 28, 2011
Studies Evaluate A1c for Diagnosing Diabetes
Following the 2010 endorsement of the hemoglobin A1c test by the American Diabetes
Association (ADA) as a way to screen for and diagnose diabetes, recent studies have
examined how well the test performs for these purposes.
Historically, diabetes screening and diagnosis in people without symptoms has hinged
on results of a fasting plasma glucose (FPG) test or an oral glucose tolerance test
(OGTT). The A1c test, which shows the average glucose level in the blood over the last
two to three months, had been used to monitor glucose control in people already
diagnosed with diabetes, but not for diagnosis. This was because of previous concerns
about the test's variability. Endorsement of A1c as a diagnostic tool by ADA, the
Endocrine Society, and the American Association of Clinical Chemistry follows huge
improvements in standardization and analytical performance of the test methods.
Now, recent studies have been undertaken to take a closer look at A1c's performance
as a diagnostic test.
One study concludes that A1c may miss some cases of diabetes. Published in the
January 2011 issue of Diabetic Medicine, the study analyzed data from the Finnish
Diabetes Prevention Study, which involved 522 overweight men and women with
confirmed impaired glucose tolerance. Of those with diabetes diagnoses based on two
OGTTs, 60% would have remained undiagnosed if diagnosis had been based on A1c
using ADA criteria, the researchers found.
Another study, published in the Dec. 1, 2010 Journal of Clinical Endocrinology and
Metabolism, reported "considerable discordance" between FPG and A1c-based
diagnosis of diabetes and pre-diabetes in elderly people. Using the ADA criteria for
diabetes and pre-diabetes, Kasia Lipska of Yale University School of Medicine and
colleagues measured A1c and FPG in 1,865 adults aged 70 to 79 who had no known
diabetes. Of these, 4.3% met either A1c or FPG criteria for diabetes. About one third of
this group had only high A1c levels, while roughly one third had only high FPG. Another
third had both elevated A1c and FPG.
Other researchers found the diagnostic performance of A1c to be lacking in sensitivity
for another age group, adolescents, compared to that of adults. Joyce M. Lee and
colleagues reported their findings in the January issue of Journal of Pediatrics. Using
the same A1c cut points as those established for adults, the researchers tested 1,156
overweight and obese adolescents ages 12 to 18 using A1c, FPG and 2-hour plasma
glucose and compared them with the results from 6,751 adults ages 19 to 70. In
detecting diabetes and pre-diabetes, A1c performed poorly for testing adolescents as
compared to adults. Tests for FPG and 2-hour PG were more sensitive for this younger
age group.
Emmes News Update
24
Contact: [email protected]
Genetic differences may explain why correlations between A1c and glucose levels
differ across populations, writes Allan S. Brett, MD in the February 1 Journal Watch
General Medicine. Genetics can produce variation in how sugars bind to proteins and
lipids and in red blood cell life span, he explains. Prior to these studies, the Endocrine
Society had called for more study of A1c as a diagnostic test in populations of nonEuropean ancestry because previous research had found that, based on A1c, more
people of non-European ancestry fall into the pre-diabetic category compared to
fasting or oral glucose tolerance testing.
Although A1c is an attractive diagnostic test because patients do not need to fast for
the test or endure multiple blood draws, doctors and laboratories have long known that
the A1c test has limitations for monitoring glucose control in some people. These
include patients with chronic kidney or liver disease, blood disorders such as irondeficiency anemia, vitamin B12 anemia, and thalassemia, or people who have recently
had severe bleeding or blood transfusions.
Patients should expect doctors to continue to use the A1c test but be aware that like
any other test, it is not perfect. "No test is 100% sensitive or specific," explains William
E. Winter, MD, of the University of Florida. If A1c results are normal but concerns about
possible diabetes continue, he recommends that doctors order the FPG test. "If this
result is not clearly abnormal and the question of diabetes persists, then an oral
glucose tolerance test can be performed," he suggests.
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Emmes News Update
25
Contact: [email protected]
April 7, 2011
Emmes Now Accepting Subscriptions To Its New 2011
Molecular Diagnostics Database
The Emmes Group, a leading provider of essential IVD market information and insights
for over 25 years is pleased to announce it is now accepting subscriptions to its
authoritative and comprehensive 2011 MDx database.
In addition to in-depth information regarding test volumes, vendor brand and specific
platform, plans to change and the reasons why, MDx send out activities, and trend
data, Emmes has added new summary tables detailing market share, segmentation
analysis (by hospital size as well as reference and public health labs), brand usage and
lab-developed tests to its 2011 MDx database.
This highly acclaimed and unique resource is extraordinarily useful for marketing, sales
management, business development, strategic planning, competitive analysis, financial
assessments and customer service. The Emmes Molecular Testing Database is easy
to use, comprehensive, efficient and interconnected. It holds promise beyond its
fundamental elements, allowing users to apply advanced analytics to improve
decision-making and leading to better results.
Molecular diagnostics is becoming a dominant platform in clinical medicine and
represents one of the fastest growing segments of the diagnostics market. For anyone
interested in better understanding the specifics of this market segment, the Emmes
Molecular Testing Database is an invaluable management resource.
The following pages contain low-resolution examples (of actual data) from the
2010 MDx Database.
To arrange for a free on-online demonstration of the 2010 MDx database and to
discuss the 2011 MDx databse please contact:
Edward Weiner
Tel: 508-358-2221
E-Mail: [email protected]
Emmes News Update
26
Contact: [email protected]
Basic Display Layout
Emmes News Update
27
Contact: [email protected]
Sample Segmentation Analysis
The data shown here (for CT/GC) is based on the initial 500 (of 1,000 records in the
2010 MDx database) and can be further broken out by vendor and/or specific vendor
platform.
It is but one of hundreds of possible ways in which to access and summarize data in
the 2010 Emmes MDx database.
Emmes News Update
28
Contact: [email protected]
Labs With Given Platform (this Example Roche LightCycler)
The data shown here (for Roche LightCyclers) is based on the initial 600 (of 1,000
records in the 2010 MDx database) and is comprised of many more pages
It is but one of hundreds of possible ways in which to access and summarize data in
the 2010 Emmes MDx database.
Emmes News Update
29
Contact: [email protected]
Accounts That Developed and Perform LDT Hombrew Tests
The data shown here (for Homebrew LDT) is based on the initial 600 (of 1,000 records
in the 2010 MDx database) and is comprised of several more pages
It is but one of hundreds of possible ways in which to access and summarize data in
the 2010 Emmes MDx database.
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Emmes News Update
30
Contact: [email protected]