How to Order Caris Target Now: Medical Oncology From Archived Specimen Requisition Instructions: 1) Complete the Patient, Client and Pathology Information sections, as well as list any additional physicians that need to be copied when the final report is released. 2) Obtain the insurance/demographic information for the patient. Patient insurance information is required prior to testing. 3) Document the Specimen Information, including Site, Date and Time of Collection. Also, detail the patient’s current treatment status and past therapies. 4) Select either the Caris Target Now Comprehensive Profile or individual assay box. A molecular profiling service must be selected in order for testing to be performed. 5) Collect the patient insurance information, pathology report and clinical history/most recent notes and fax to (866) 479-4925. 6) Contact your pathology department to request specimen be sent to Caris for molecular profiling. *If a surgical procedure is planned, provide the anticipated specimen information, date and time of procedure and the location/facility information. Formalin Fixed Paraffin Embedded (FFPE) Samples Sufficient tumor must be present to complete all testing. If you have any questions, please contact Client Services at (800) 901-5177. SPECIMEN TYP E S P E C I M E N R E Q U I R E M E NT S Fixed Tissue One (1) FORMALIN FIXED paraffin embedded block (FFPE) containing tumor from most recent surgery or biopsy Unstained Slides Fifty-five (55) unstained, positively charged, unbaked slides from one single paraffin block Bone Marrow Core or Clot Clot Preferred: Core accepted • Core should be decalcified • Formalin fixed core and/or clot should be paraffin-embedded Core Needle Biopsy Four to six (4-6) biopsies paraffin-embedded • 18 gauge needle preferred Malignant Fluids Sufficient volume of fresh pleural/ascitic fluid to produce a 5x5x2mm cell pellet • Collect and process within 30 minutes of procurement • FORMALIN FIX and paraffin block • DO NOT expose to alcohol fixation Fine Needle Aspirate (FNA) Four to six (4-6) aspirates paraffin-embedded Formalin Samples Sufficient tumor must be present to complete all testing. If you have any questions, please contact Client Services at (800) 901-5177. SPECIMEN TYP E S P E C I M E N R E Q U I R E M E NT S Fresh Tissue Prepare two or more samples with a minimum thickness of ~3mm (height, width, length) in formalin. Core Needle Biopsy Submit four (4) or more cores in formalin, from 18g needle minimum. Contact Caris Client Services with questions or to request a pick up at (800) 901-5177. C A R I S TA R G E T N O W Caris Target Now Tumor Profiling Requisition A completed requisition and patient insurance information is required for Caris Target Now molecular profiling to be performed, however if you do not have all the information on your patient at this time, please COMPLETE the highlighted areas. Client Services will contact you to clarify any discrepancies and obtain the remaining information. Caris Target Now™ Tumor Profiling Requisition Fax completed requisition with a copy of the pathology report, clinical history and insurance information to 866.479.4925. 1 Patient Information Enter patient demographic information here. This information is mandatory per CLIA / CAP requirements. First Name MI Street Address City 3 Pathology Information Typically, specimens are submitted through pathology. This information is critical to ensure the timely delivery of specimen. State Patient Phone # Patient Work Phone # Patient MR# DOB Office/Facility Name Billing Information Billing information is required to initiate testing. A copy of the front and back of the insurance card is acceptable. Client Information Apt# Account # Zip Ordering Physician Enter the ordering physician’s contact information. This section can be pre-populated with your practice information. Call Client Services to learn more. NPI # Age Sex Address Physician’s Signature City State Notes: Phone # Fax PATHOLOGY INFORMATION ADDITIONAL PHYSICIANS TO BE COPIED Institution/Hospital Name: Name: Facility/Office Name: Zip 4 Additional Physician To Be Copied List any additional physicians that should receive a copy of the final report. Facility/Office Name: Phone #: Fax #: Phone #: Fax #: BILLING INFORMATION Face sheet and front/back of PRIMARY and SECONDARY insurance cards MUST BE attached or you will be contacted for billing information. ICD-9 Code(s) (Please provide as many “symptomatic diagnosis” codes as applicable): Patient Status: q Hospital Inpatient q Hospital Out Patient q Non-Hospital Patient Primary Insurance: 5 2 CLIENT INFORMATION PATIENT INFORMATION Last Name Hospital Name: Secondary Insurance: Policy #: Group #: Insured Name: Policy #: DOB: Group #: Insured Name: Relationship To Patient: q Self q Spouse q Child q Other: DOB: Relationship To Patient: q Self q Spouse q Child q Other: SPECIMEN INFORMATION Please include a copy of the pathology report. Primary Tumor Type: q Unknown (Microarray cannot be performed on tumors of unknown primary) Specimen Site: Specimen ID#(s): / Date and Time of Collection: Tissue Type(s): q FFPE Block q Formalin Fixative q Fresh Frozen q RNA Preservative q Fluid q Unstained Slides / AM PM Duration of Fixation: TREATMENT STATUS The panel of biomarkers may change per tumor type. Treatment Status: Prior Therapy: q Primary q Recurrence/Progression/Metastasis First Line: Current Therapy: Second Line: Third Line: TEST REQUESTED (CHOICE REQUIRED) See reverse for additional service information and specimen requirements. 6 Molecular Profiling Services (CHOICE REQUIRED) Clearly indicate which service is to be performed. A selection MUST be made, or Client Services will contact the office. Caris Target Now is an evidence-based molecular profiling service that involves the analysis of relevant biomarkers to identify therapeutic associations with potential benefit or potential lack of benefit for your patient. The tests performed vary based on the service chosen and the tumor type submitted, and they are determined by a panel of Caris oncologists, pathologists, and molecular geneticists who continually review relevant clinical literature. A complete list of tests performed by tumor type may be found at www.CarisTargetNow.com. BY COMPREHENSIVE PROFILE: INDIVIDUAL ASSAY: q CARIS TARGET NOW IHC, DNA Microarray, Mutation and/or FISH analysis (See reverse for panel description) q Perform Selected Test(s) Only q In Addition to Caris Target Now Profile Special Instructions: MUTATIONAL ANALYSIS q MICROARRAY (RNA Expression Analysis) IHC ASSAY q ERCC1 q MRP1 q BRAF q EGFR q NRAS q c-KIT q KRAS q PIK3CA q TOPO2A q RRM1 q TOPO2A FISH q SPARC q TS q ALK q EGFR q TUBB3 q c-MET q HER-2 q AR q CK 5/6 q COX-2 q BCRP q CK14 q Cyclin D1 q HER-2 q p53 q CAV-1 q CK17 q E-Cad q IGF1R q PGP q CD20 q c-KIT q EGFR q Ki67 q PR q TLE3 q CD52 q c-MET q ER q MGMT q PTEN q TOPO1 MONO & Polyclonal q c-MYC q PIK3CA 7 Back Page The back page includes specimen requirements and additional service information for Caris Target Now. Fax completed requisition to 866.479.4925 OR contact 800.901.5177 to arrange specimen pickup. Please attach the following: • Copy of face sheet and/or insurance card • Copy of most recent patient notes or clinical history that includes prior therapies • Pathology/cytology report Our policy is to bill Medicaid and Medicare for testing only if it is medically necessary for the diagnosis and treatment of the patient. Medicare does NOT pay for routine screening tests, tests ordered for the purpose of research only, or tests that are experimental. We therefore consider your instruction that we bill Medicaid or Medicare to reflect your view that the ordered services meet these requirements. PLEASE SEE THE REVERSE FOR CMS BILLING REQUIREMENTS AND OPTIMAL SPECIMEN REQUIREMENTS. 4610 South 44th Place / Phoenix, Arizona 85040 / 800.901.5177 / Fax: 866.479.4925 / CLIA 03D1019490 6655 North MacArthur Blvd./ Irving, Texas 75039 / 800.901.5177 / Fax: 866.479.4925 / CLIA 45D2032834 Caris Lab (White) Client Copy (Pink) TN0034 12.11 Fax completed requisition with copy of the pathology report, clinical history and insurance information to (866) 479-4925. To order Caris Target Now™ services or to speak with a Caris Life Sciences™ representative, call (800) 901-5177 or visit us online at www.CarisTargetNow.com. © 2012 Caris Life Sciences, Inc. All rights reserved. TN0068 1.12