How to Order Caris Target Now A formalin-fixed, paraffin-embed (FFPE) block or slides must be submitted in order for Caris Target Now molecular profiling to be performed. Requisition Form Instructions: Medical Oncology 1) Complete the Treating Physician, Patient and Pathology information sections, as well as list any additional physicians that need to be copied when the final report is released. 2) Select the appropriate Billing process. Patient is billed directly, a separate form is provided with payment information. An agreed payment method is required prior to testing. The institution is billed, prior or after tumour profiling is performed, based on agreement. 3) Document the Specimen Information, including Primary Tumour Site, Specimen Site, Specimen block ID#, Date of Collection and Pathology Diagnosis. 4) Choose either the Caris Target Now Comprehensive Profile, one Caris Target Now Select profile or individual assay box. A molecular profiling service must be selected in order for testing to be performed. 5) Collect the pathology report and if possible clinical history/most recent notes and fax to +41 21 533 53 01 / +800 12 12 32 32 or email to [email protected]. 6) Contact your pathology department to request specimen be sent to Caris Life Sciences for molecular profiling. Pathology Department 7) Place into the shipper kit: the specimen, pathology report, copy of the requisition form, and if possible clinical history/most recent notes. If not done previously, fax the documents to +41 21 533 53 01 / +800 12 12 32 32 or email to [email protected] 8) Call FedEx to arrange pick-up. Formalin Fixed Paraffin Embedded (FFPE) Samples Sufficient tumour must be present to complete all testing. If you have any questions, please contact Client Services. SPECIMEN TY P E S P E C I M E N R E Q U I R E M E NT S Fixed Tissue One (1) tumour-containing formalin fixed paraffin embedded block (FFPE) from most recent surgery or biopsy. Tumour cells will be excised by microdissection from successive five micron sections of the block until a total area of at least 15 mm2 is obtained for Caris Target Now Select profiles, and 30 mm2 for Caris Target Now Comprehensive. Core Needle Biopsy Four to six (4-6) biopsies formalin fixed paraffin embedded t HBVHFOFFEMFQSFGFSSFE t GPVSUPTJY BTQJSBUFTBSFSFDPNNFOEFE Fine Needle Aspirate (FNA) One (1) formalin fixed paraffin embedded block from a cell block containing sufficient tumour Unstained Slides Unstained, positively charged, unbaked slides from one single, tumour-containing formalin fixed paraffin embedded block; 5 micron sections t$BSJT5BSHFU/PXSelect for Breast – 29 slides t$BSJT5BSHFU/PXSelect for Colorectal – 15 slides t$BSJT5BSHFU/PXSelect for Melanoma – 20 slides t$BSJT5BSHFU/PXSelect for NSCLC – 26 slides t$BSJT5BSHFU/PXSelect for Ovarian Surface Epithelial – 23 slides t$BSJT5BSHFU/PXComprehensive for – 47 slides Note: At least a 5mm x 5mm section of tissue per slide is required. For small biopsies (tissue area < 5 mm x 5 mm) please cut two sections per slide for at least one half of the slides to ensure sufficient material for molecular assays. Contact Caris Client Services with questions or to request a pick up at +41 21 533 53 00 / +800 12 12 30 30 or email to [email protected]. C A R I S TA R G E T N O W Caris Target Now Tumour Profiling Requisition A completed requisition and an agreed payment method are is required for Caris Target Now molecular profiling to be performed, at a minimum please COMPLETE the highlighted areas. Client Services will contact you to clarify any discrepancies and obtain the remaining information. Caris Target Now™ Tumour Profiling Requisition Complete and fax or e-mail requisition with copy of pathology report to +800 12 12 32 32 or +41 21 533 53 01 or [email protected]. The pathology report must bear the name of the originating institution and be stamped “controlled copy.” Please send the original copy of the requisition with the specimen. All fields marked with an asterisk (*) are required. Client Information Enter the treating physician’s contact information. TREATING PHYSICIAN INFORMATION PATIENT INFORMATION * Office/Facility Name * Last Name Caris Account Number/Distributor * First Name Initial * City * Address * City * Country * Phone Nr. Fax Nr. * Postal Code * Country * Postal Code * Date of Birth (dd/mm/yyyy) Age Phone Number * Sex Email Address PATHOLOGY INFORMATION * Institution/Hospital Name * Pathologist Name * Institution/Hospital Address: * City * Phone Nr: Billing Information Billing information is required to initiate testing. Patient Information Enter patient demographic information here. * Address * Ordering Physician * Country * Fax Nr: * Postal Code Return Specimen Block To: Pathology Ordering Physician Caris to Archive Return addresses must be provided above in order to return block Pathology Information Enter the pathology information in this section. Please include any hospital/institution affiliation. BILLING INFORMATION Patients: An agreed payment method is required before testing starts. A separate form is provided to request payment information. Hospitals/Clinics: Institutions will be billed after the tumour profiling is performed. SPECIMEN INFORMATION Include a copy of the pathology report. * Primary Tumour Type Shipment Tracking # * Specimen Site * Specimen/Block ID#(s) Date & Time of Collection / / Duration of Fixation Tissue Type(s): FFPE Block AM PM Unstained Slides SERVICE REQUESTED (CHOICE REQUIRED) Choose one Caris Target Now Select profile, OR Caris Target Now Comprehensive, OR Individual Assay(s). Indicate which profile is to be performed from the list below. The profiles will be performed as indicated. To order specific assays, choose from the individual assays. While every attempt is made to keep this requisition current, the definitive list of assays included in each profile can be found online at www.CarisLifeSciences.eu/profilemenu. Molecular Profiling Services (CHOICE REQUIRED) Clearly indicate which service or individual assay is to be performed.. A selection MUST be made. Caris Target Now Select Caris Target Now Comprehensive Focused biomarker analysis for standard, tumour specific therapeutic associations Breast IHC: ER HER2 PR PTEN TLE3 FISH or CISH: HER2 TOP2A RFLP: ALK Colorectal RT-PCR: BRCA1 ERBB3 ERCC1 RRM1 TOPO1 TS Sequencing: BRAF KRAS PIK3CA IHC: PTEN RT-PCR: AREG EGFR ERCC1 EREG TOPO1 TS Melanoma IHC: MGMT PTEN SPARCm SPARCp RT-PCR: ERBB3 ERCC1 TUBB3 Sequencing: BRAF KRAS NRAS PIK3CA RFLP: ALK Sequencing: BRAF cKIT GNA11(uveal melanoma only) GNAQ (uveal melanoma only) NRAS PIK3CA Mutational Analysis by PCR: BRAF Broad biomarker analysis for therapeutic associations across all tumour types Ovarian Surface Epithelial NSCLC IHC: RT-PCR: cMET BRCA1 EGFR (H-score) EGFR PTEN ERCC1 TLE3 RRM1 TS FISH or CISH Sequencing: ALK BRAF cMET EGFR HER2 KRAS PIK3CA RFLP: ALK EGFR IHC: cMET ER HER2 PR PTEN TLE3 Comprehensive (AVAILABLE FOR ALL SOLID TUMOURS) IHC: AR cMET EGFR (H-score; NSCLC Only) ER HER2 MGMT PR PTEN SPARCm SPARCp TLE3 RT-PCR: BRCA1 ERBB3 ERCC1 RRM1 TOPO1 TOP2A TS Sequencing: PIK3CA FISH or CISH: ALK (NSCLC only) cMET HER2 TOP2A (breast only) Not all tests will result in a therapeutic association. RT-PCR: AREG BRCA1 EGFR ERBB3 ERCC1 EREG Pgp RRM1 TOPO1 TOP2A TS TUBB3 Sequencing: BRAF cKIT EGFR (NSCLC only) GNA11 (uveal melanoma only) GNAQ (uveal melanoma only) KRAS NRAS PIK3CA Mutational Analysis by PCR: BRAF (melanoma only) RFLP: ALK EGFR (NSCLC only) Individual Assay (Due to the custom nature of individual test ordering, turn-around-time may differ from the above profiles) IHC FISH or CISH AR cMET EGFR (H-score; NSCLC Only) ER HER2 MGMT PR PTEN SPARCm SPARCp TLE3 RT-PCR AREG BRCA1 EGFR ERBB3 ALK cMET HER2 TOP2A This document constitutes an order by the treating physician and an attestation of medical necessity. Sequencing ERCC1 EREG Pgp RRM1 TOPO1 TOP2A TS TUBB3 Physician or Practitioner Signature BRAF cKIT EGFR RFLP GNA11 GNAQ KRAS NRAS PIK3CA Print Name ALK EGFR Mutational Analysis by PCR BRAF (melanoma only) Date CARIS TARGET NOW REPORT WILL BE DELIVERED IN ENGLISH. PLEASE SEE THE REVERSE FOR SPECIMEN REQUIREMENTS. Specimen must be sent to Caris Life Sciences, Attn. Caris Target Now, 4610 South 44th Place, Phoenix AZ 85040, USA / CLIA 03D1019490 Caris Life Sciences Europe Customer Services Phone +800 12 12 30 30 or +41 21 533 53 00 / Fax +800 12 12 32 32 or +41 21 533 53 01 / E-mail [email protected]. Caris MPI, Inc. d/b/a Caris Life Sciences ©2012 Caris Life Sciences and affiliates. All rights reserved. Physician or Practitioner Signature (SIGNATURE REQUIRED) Signing the requisition authorises Caris Target Now to perform molecular profiling services. EA61AE / Revision Date 6.19.2012 Fax completed requisition with copy of the pathology report, clinical history and payment information to +41 21 533 53 01 / +800 12 12 32 32 or email to [email protected]. To order Caris Target Now™ services or to speak with a Caris Life Sciences® representative, call + 41 21 533 5 3 0 0 / + 8 0 0 1 2 12 3 0 3 0 or email to [email protected], or visit us online at www.carislifesciences.eu. © 2012 Caris Life Sciences and affiliates. All rights reserved. EA50AE
© Copyright 2024