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The trademarks mentioned herein are the property of AB SCIEX Pte. Ltd. or their respective owners. AACC Booth #4824 internal standards for LC-MS/MS? ask the experts For a complete list of our Certiﬁed Spiking Solutions® for Clinical LC-MS/MS Applications, visit Cerilliant.com U Analgesics Label incorporation as well as isotopic purity and distribution can U Antidepressants impact results. At Cerilliant we synthesize over 90% of the stable U Antiepileptics labeled compounds used in our Snap-N-Spike® Certiﬁed Reference U Antipsychotics Materials giving us control over synthetic design and quality U Caffeine-related Drugs U Cardiac Drugs U Catecholamines U Hormones speciﬁcations. 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Clin Chem The Clinical Chemistry Trainee Council It’s even easier to be a part of it! Sign up for free with our new one-step registration at traineecouncil.org Now available in español at traineecouncil.org/spanish Even more content – t t t t t Pearls of Laboratory Medicine CouncilChat Podcasts Webcasts Q&As Familial Hypercholesterolemia (FH) Array A rapid, genetic assessment of patients with suspected FH The FH Array from Randox offers rapid simultaneous detection of 20 mutations within the LDLR, ApoB and PCSK9 genes. s s s s s s Rapid, simple method for determining mutational status Innovative multiplexing Biochip Array Technology reduces time and costs Samples can be assessed in small batches Easy to interpret results using the Evidence Investigator semi-automated analyzer Protocol and reagents optimized for the molecular laboratory Only a small sample of genomic DNA required Visit us at AACC Clinical Lab Expo, Booth #3245 Providing accurate diagnosis, enabling tailored treatment and improved patient outcomes Randox Laboratories-US Limited, 515 Industrial Boulevard, Kearneysville, West Virginia, 25430 T +1 304 728 2890 TOLL FREE 866 4 RANDOX F +1 304 728 1890 TOLL FREE 866 RANDOX 1 I www.randox.com E [email protected] MOLECULAR DIAGNOSTICS 2014 Special Issue call for papers Clinical Chemistry Advancing Women’s Health: The Impact of Biomarkers and Genomics Submit Now Clinical Chemistry is pleased to announce a special upcoming theme issue on Women’s Health edited by Drs. Ann M. Gronowski, JoAnn E. Manson, Elaine R. Mardis, Samia Mora, and Catherine Y. Spong titled “Advancing Women’s Health: The Impact of Biomarkers and Genomics.” Clinical Chemistry, published by the American Association for Clinical Chemistry, is the most highly cited forum for peer-reviewed, original research in the fields of clinical chemistry and laboratory medicine. The purpose of this issue is to highlight recent advances in biochemical and genetic markers used for the diagnosis, therapy, and preventive care of women during all stages of life. This issue will include diverse themes such as cancer, cardiovascular disease, osteoporosis, metabolic disease, normal and abnormal pregnancy, infertility, and infectious disease. Clinical Chemistry invites authors to submit original articles related to women’s health to be considered for publication in this special issue. Potential topics of interest include: s Discovery and validation of novel biomarkers for the diagnosis, prognosis, and monitoring therapy of s s s s s s s s diseases that affect women including: cancer, cardiometabolic and/or cerebrovascular disease, bone disease, and autoimmune disorders The genomics of ovarian, uterine, cervical, and breast cancer The effect of gender on the risk factors and outcomes related to diabetes, obesity, and cardiovascular disease Changes in the microbiome and biomarkers related to pregnancy Novel molecular diagnostic tools for pre-implantation genetic analysis Non-invasive screening for fetal aneuploidies and other pregnancy outcomes Novel biomarkers for the diagnosis of pregnancy-related disorders such as pre-eclampsia, ectopic pregnancy, preterm delivery, and gestational diabetes Biomarkers for the diagnosis of infertility, menopause, and premature ovarian failure The impact of infectious disease on the global health of women Be a part of this exciting issue. Submit now! Submissions must be received through our online submission system at http://submit.clinchem.org. We welcome submissions after July 1, 2013, but cannot guarantee the inclusion of late submissions for the Special Issue. Your cover letter should express your interest in submitting your paper for consideration for the Women’s Health theme issue. Journal guidelines for submission apply as described in the Information for Authors on the submission website. With Simoa, researchers count individual protein molecules, achieving 1000 fold improvements in sensitivity over current immunoassays. Join the digital revolution and discover the extraordinary insights Simoa can deliver. www.quanterix.com/simoa 2013 A A C C A N N U A L M E E T I NG P L E NA R Y S E S S I O N S July 28–August 1, 2013 George R. Brown Convention Center Houston, Texas 46/%":+6-:tQNoQN DECONVOLUTING THE METABOLIC SYNDROME AT A MOLECULAR LEVEL C. Ronald Kahn, MD Type 2 diabetes (T2D) and metabolic syndrome are each the result of a complex interaction between genes and environment. Studies in humans have identified multiple genetic loci which contribute to these disorders, but most have very small impact on disease expression. Mouse models provide a powerful tool to investigate gene-environment interactions in disease susceptibility. For example, among inbred mice, the C57BL/6J mouse is susceptible to diet-induced T2D and metabolic syndrome, whereas the 129 mouse is resistant to these phenotypes, despite the fact that it eats more and moves less than the B6 mouse. Using these and other mouse models, we have now identified genes which contribute to disease susceptibility. We have also explored the role of environmental factors, including the gut microbiome. These studies allow us for the first time to unravel how diet, genetic background, as well as environment, contribute to creating common metabolic diseases like obesity and T2D. Come Prepared: Bezy O, Tran TT, Pihlajamäki J, Suzuki R, Emanuelli B, Winnay J, et al. PKCð regulates hepatic insulin sensitivity and hepatosteatosis in mice and humans. J Clin Invest 2011;121:2504-17. .0/%":+6-:tBNoBN CHALLENGING THE DOGMA: A NEW VIEW OF THE GENOMIC PROGRAMMING OF HUMAN DEVELOPMENT John Mattick, PhD Noncoding DNA accounts for 98.8% of the human genome. Many of these sequences are being shown to have important functions in differentiation and development, as well as in cancer and other complex diseases. This session will examine the role of this noncoding or junk DNA in human development. 56&4%":+6-:tBNoBN THE VITAMIN D DEBATE: IS ENTHUSIASM OUTPACING THE EVIDENCE? Vitamin D has been implicated in the prevention of cancer, cardiovascular disease (CVD), diabetes, infections, depression, asthma, autoimmune diseases, and many other disorders. The available research derives primarily from laboratory research and observational epidemiologic studies, but large-scale randomized trials of vitamin D are very limited. Small randomized trials to date have provided mixed and inconclusive results. Although many experts are now recommending vitamin D intakes at levels far above the IOM’s dietary recommended allowance (RDA), this remains controversial. Two experts involved with vitamin D research will debate the evidence for and against public health recommendations for vitamin D intakes above the RDA for the general population. Advocating for Increased Intake – Bruce W. Hollis, PhD Bruce W. Hollis, PhD, Professor and Director of Pediatric Nutritional Sciences at Medical University of South Carolina, will review and present evidence for higher vitamin D intakes required to sustain adequate nutritional vitamin D status for all aspects of human development including pregnancy and lactation. Human lactation and nourishment of the human neonate provides the most clear-cut evidence of why recent IOM recommendations fall far short of what is actually required for adequate vitamin D intakes. Come Prepared: Hollis BW and Wagner CL. Vitamin D and pregnancy: skeletal dffects, nonskeletal effects, and birth outcomes. Calcif Tissue Intl 2013; 92:128-39. S UND A Y, JUL Y 2 8 – T H U R S DA Y , A U G U S T 1 , 2 013 Opposing Increased Intake – JoAnn E. Manson, MD, DrPH JoAnn E. Manson, MD, DrPH, endocrinologist, Professor at Harvard Medical School, and Principal Investigator of the large-scale VITamin D and OmegA-3 TriaL (VITAL), will review the scientiﬁc evidence for the role of vitamin D in the prevention of cancer, CVD, and other chronic diseases. She will address design issues relevant to current research, including the potential for confounding in observational studies, and will emphasize the critical need for large-scale randomized trials before recommending high-dose vitamin D supplementation (well above the RDA) for the general population. Come Prepared: Ross AC, Manson JE, Abrams SA, Aloia JF, Brannon PM, Clinton SK, et al. The 2011 report on dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know. J Clin Endocrinol Metab 2011; 96:53–8. 8&%/&4%":+6-:tBNoBN PATIENT-BASED THERAPEUTICS DISCOVERY Stuart L. Schreiber, PhD Human biology, insights gained from patients, and small-molecule science offer a powerful way to propel the understanding and treatment of human diseases. The ability to measure heritable and somatic genetic variation in humans with and without disease offers a particularly promising avenue towards new small-molecule therapeutics. For this approach to be successful, we will need to relate human genetic variation to small-molecule sensitivity and drug efﬁcacy as comprehensively as possible. Therapeutic targets that emerge from human biology and patients have been validated to some degree prior to clinical testing by genetic “experiments of nature.” But the therapeutic targets that emerge are often unfamiliar to traditional small-molecule drug discovery efforts. Thus, advances in chemistry and chemical biology are also required to test hypotheses emerging from human biology in humans with small molecules. Come Prepared: The Cancer Target Discovery and Development Network, Schreiber SL, Shamji AF, Clemons PA, Hon C, Koehler AN, et al. Towards patient-based cancer therapeutics. Nature Biotech 2010; 28:904-906. 5)634%":"6(645tQNoQN DINING IN WITH TRILLIONS OF FASCINATING FRIENDS Jeffrey Gordon, MD Our genetic landscape is a summation of the genes embedded in our human genome and in the genomes of our microbial symbionts (the microbiome). Similarly, our metabolic features (metabotypes) are an amalgamation of human and microbial contributions. Therefore, understanding of the range of human genetic and metabolic diversity means that we must characterize our microbiomes, which contain >100-fold more genes than our human genome, as well as the factors that inﬂuence the properties of our microbial communities. The results should provide an additional perspective about contemporary human biology as we seek to understand how our changing lifestyles, cultural norms, socioeconomic status, and biosphere are inﬂuencing our microbial ecology and health status. I will discuss the results of our group’s ongoing studies of the interrelationships between diet and the structure and dynamic operations of the human gut microbiome. We believe that understanding these interrelationships is important for advancing our appreciation of the nutritional value and health effects of food ingredients, for creating new nutritional guidelines for humans at various stages of their lifespan, and for developing new ways to deliberately manipulate the properties of the gut microbiome to prevent or treat various diseases, including those manifested by immune dysfunction. Come Prepared: Smith MI, Yatsunenko T, Manary MJ, Trehan I, Mkakosya R, Cheng J, et al. Gut microbiomes of Malawian twin pairs discordant for kwashiorkor. Science 2013;339:548-54. Gordon, JI. Honor thy gut symbionts redux. Science 2012; 336:1251-3. 2013 WEBINARS The AACC/Seattle e Children’s Hosp pital Don’t miss this series of eight webinars designed just for you. Tools and skills to perform your duties more effectively Proven techniques to manage complex human resource issues AVAI A LLA ABL BLE E NO OW Hap appy y Lab b, Happy Ha y Li Liffe:: Ad A drresssi sin ng Com ng mmonlly N Ne egl gle ected ecte d Hu Huma man Reso source Con onsi sid si idera derati tion ti o s in the on e Lab ab MARCH 14 1 Connecting Laboratory Staff to the Patien nt Experience: A Recip ip pe for Labo orato tory Succe cesss ce ss APRILL 16 AP Tweetin i g vs vs.. Kn nit i ting ng: Over erco comi ming i Gener erat atio ional Co Conﬂ ﬂictts in the Cli linical Lab MAY 9 MA U in Us ng Me Metr triccs in the he Q Qua u liity LLab abor orat a ory: The at h Good, the Bad and the Ugly AU AUGU UGUST GUST 2 22 2 Cre reat atin at i g, in g Com mmu uni nica cati ca ting ti ng,, an a d Ma M in nta tain inin ing Ef Efffect ctiv ct ive iv ve La Lab bora bo rato tory ry SOP SOPs OPs SEPTEMBER 24 Designing and Using the Laboratory Quality Dashboard OCTOBER 15 Modern Approachess to Quality Contro ol: M Mov ovin ing g Averages es and Bey Beyond NOVEMBER 21 Achieving h Concordance d Bettween POCT Resullts and Central Lab b Results Moderated by: Michael Astion, MD, PhD Division Chief, Laboratory Medicine, Seattle Children’s Hospital, and Clinical Professor, University of Washington Department of Laboratory Medicine Webinars take place from 2:00 – 3:00 pm Eastern U.S. Time (11:00 am – 12:00 pm Paciﬁc U.S. Time) Each program is 60 minutes long. Registration per program is $195. To register, visit aacc.org, click on the Events tab and choose “Webinars.” Or call AACC Customer Service at 800.892.1400 or 202.857.0717. Presented by and CONFERENCE St. Louis, Mo. Mass spectrometry is fast becoming the analytical method of choice for many clinical assays. This program will tackle and attempt to demystify some of the issues that have arisen as this technology evolves into a routine laboratory tool. Leading clinical experts in mass spectrometry will show you: • • • • • Whether mass spectrometry is right for your application How to overcome challenges in sample prep New guidelines for mass spectrometry method development and validation Ways to manage and maintain data Post-analytical QA/QC of your mass spec methods In addition, we’ll examine some of the applications already being used in the clinical lab, including: • • • • TDM and immunosuppressants Pain management Toxicology screening and conﬁrmation Androgen and vitamin D analyses Join our expert faculty as they highlight the areas where early adopters are using mass spectrometry-based test platforms; medical and business issues to consider when introducing mass spectrometry assays or expanding the mass spectrometry test menu; validation and QC concerns; and options in data management. Register today at www.aacc.org/events ........ Health literacy, now in the palm of your hand. Connect to Lab Tests Online Mobile. 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This is THE place to learn about cutting edge technology in laboratory medicine. + + 17,000+ Attendees. Join the global leaders in clinical chemistry, JULY 28-AUGUST 1, 2013 molecular diagnostics, mass spectrometry, translational medicine, GEORGE R. BROWN lab management, lab medicine and more. CONVENTION CENTER 5 Packed Days. Build your agenda with educational sessions, HOUSTON, TEXAS USA networking, new science and technology previews, and more. The New York Times recently ranked Houston as one of the top places to see in 2013. REGISTRATION NOW OPEN www.aacc.org/2013am IBD diagnostics & therapy control Calprotectin & TNFD blocker monitoring PhiCal® Calprotectin ELISA ÂFecal calprotectin: Established marker of intestinal inflammation ÂFor the differentiation of IBD and IBS ÂFor therapy monitoring of IBD patients No able i w a va i l n the U SA! 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