Tumor Profiling Requisition Fax completed requisition with a copy of the pathology report, clinical history and insurance information to (866) 479-4925. TREATING PHYSICIAN INFORMATION PATIENT INFORMATION NameNPI# Last Name Office/Hospital Name Address Street Address Apt# City StateZip City Zip Phone # Fax # Patient Phone # Patient Work Phone # Patient MR # DOB Contact Name First Name ADDITIONAL PHYSICIAN (If different than above) PATHOLOGY INFORMATION NameFacility Pathologist/Pathology Services Address City Phone # Fax # State State MI Gender Male Female Hospital CityState Zip PhoneFax Zip BILLING INFORMATION (Attach the front and back of PRIMARY and SECONDARY insurance cards. Patient insurance/payment is REQUIRED to begin testing.) ICD-9 Code(s) (Please provide as many “symptomatic diagnosis” codes as applicable): Bill: Self Pay Insurance Indigent Care website for eligibility Medicare (Visit requirements.) Other: ___________________ POLICY # GROUP # INSURED NAME RELATIONSHIP TO PATIENT INSURED DOB Primary Insurance: Secondary Insurance: Self Spouse Child Other ______________________ Self Spouse Child Other ______________________ SPECIMEN INFORMATION (Include a copy of the pathology report) Specimen Collection Location Office/Clinic Ambulatory Center Hospital Outpatient Hospital Inpatient – Date of Discharge ________________ Primary Tumor Site Date & Time of Collection (Formalin Vials) / / AM PM Specimen Collection Location Name Specimen Site Duration of Fixation (FFPE Blocks) Tissue Type(s): FFPE Block Specimen/Block ID#(s) Formalin Fixative* Unstained Slides *Submission of these samples constitutes a pathology consult by Caris (CPT 88305). CARIS MOLECULAR INTELLIGENCE™ TUMOR PROFILING OPTIONS (Choice Required) Select a service or individual assay(s) to be performed from the list below. See reverse side for profile details. While every attempt is made to keep this requisition current, the definitive list of assays included in each profile and list of available biomarkers can be found online at www.CarisMolecularIntelligence.com/profilemenu. SERVICES (See reverse for further details) INDIVIDUAL ASSAY(S) MI Profile™ Multi-platform, solid tumor biomarker analysis for therapeutic decision support and clinical trials matching (see reverse for profile details) Helpful when: • treating aggressive, rare or refractory cancers • looking for clinical trial opportunities Next-Generation Sequencing Cancer Service – Only Solid tumor, 46-gene sequencing profile (see reverse for biomarker list) The biomarkers included in MI Profile™ and Next-Generation Sequencing Cancer Service may change from time-to-time. As a result, the listing on this printed requisition may occasionally become outdated for a short period of time. Before ordering testing services, please refer to the website, www.CarisMolecularIntelligence.com/profilemenu, to view the most up-to-date listing of biomarkers that will be performed. IHC AR cMET EGFR ER ERCC1 H3K36me3 (kidney only) HER2 MGMT PBRM1 (kidney only) PD-1 1 2 PD-L1 Pgp PR PTEN RRM1 SPARCm SPARCp TLE3 TOPO1 TOP2A TS TUBB3 Mismatch Repair1: (includes 4 IHCs below) performed for CRC and endometrial carcinomas Assay may be performed by an external reference laboratory. MLH1 MSH2 MSH6 PMS2 FISH or CISH 1p19q (glioma only) ALK cMET EGFR MDM2 HER2 ROS1 TOP2A Mutational Analysis BRAF2 (cobas® PCR) EGFRvIII (Fragment Analysis) IDH2 (SangerSeq) MGMT Methylation Analysis (PyroSeq) MSI1 (Fragment Analysis) Individual Next-Generation Sequencing Genes (List the genes to be performed. See reverse for gene list): ___________ ___________ ___________ ___________ ___________ ___________ ADDITIONAL SERVICES Pathology Consult – Perform a pathology review/consult (CPT: 88305*, or 88321, or 88323) on the specimen submitted. Yes Clinical Trials Connector™ – The MI Profile™ report includes information on relevant clinical trials. To decline the service, check box. Do Not Provide Information on Clinical Trials SPECIAL INSTRUCTIONS Physician Initials Notice: This requisition constitutes an order for services. I certify (a) that the services are medically indicated Physician or Practitioner Signature Print Name Date and necessary and will assist me in treating my patient, (b) that I maintain and will make available patient medical records documenting the foregoing, and (c) I have supplied information to the patient regarding testing and if required by law, the patient has given consent for testing to be performed. PLEASE SEE THE REVERSE FOR CMS BILLING AND PATIENT CONSENT REQUIREMENTS, PROFILE DESCRIPTIONS AND OPTIMAL SPECIMEN REQUIREMENTS. 4610 South 44th Place, Suite 100 / Phoenix, Arizona 85040 / (888) 979-8669 / Fax: (866) 479-4925 / CLIA 03D1019490 / CAP 7195577 / ISO 15189:2012 – 3531.01 Caris MPI, Inc. d/b/a Caris Life Sciences ©2014 Caris Life Sciences. All rights reserved. TN0034 .5 / Revision December 18, 2014 Physician will be solely responsible for confirming that legally-effective informed consent has been obtained from the patient or his/her authorized representative as required by applicable state law. By ordering a test from Caris Life Sciences, physician certifies that this consent is in place and that test results will be used and disclosed only in accordance with applicable law. Menu of Services While every attempt is made to keep this requisition current, the definitive list of assays included in each profile and list of available biomarkers can be found online at www.CarisMolecularIntelligence.com/profilemenu. Before ordering testing services, please refer to the profile menu online to view the most up-to-date listing of biomarkers that will be performed. Tests may vary if insufficient tumor samples are submitted. Please refer to the specimen requirements below for more information. MI Profile™ IHC FISH / CISH AR, cMET, EGFR (H-score; NSCLC only), EGFR (excluding NSCLC), ER, ERCC1 (ovarian only), HER2, MGMT (excluding glioma), MLH1 (CRC only), MSH2 (CRC only), MSH6 (CRC only), PD-1, PD-L1, Pgp, PMS2 (CRC only), PR, PTEN, RRM1, SPARCm, SPARCp, TLE3, TOP2A (excluding breast), TOPO1, TS, TUBB3 1p19q# (glioma only); cMET#, HER2#, TOP2A# (breast only), ALK# (NSCLC only), ROS1# (NSCLC only) Mutational Analysis Next-Generation Sequencing Other See MI Profile™ Next-Generation Sequencing Genes below. EGFRvIII (Frag. Analysis; glioma only), IDH2 (SangerSeq; glioma only), MGMT Methylation Analysis (PyroSeq; glioma only) MSI (Frag. Analysis; CRC only) # Assay may be performed by an external reference laboratory. Next-Generation Sequencing Cancer Service Additional Next-Generation Sequencing Genes (excluded from MI Profile™) MI Profile™ Next-Generation Sequencing Genes ABL1 BRCA1* EGFR GNA11 JAK2 MPL PTEN CDH1 NPM1 AKT1 BRCA2* ERBB2 (HER2) GNAQ KDR (VEGFR2) NOTCH1 RET ERBB4 PTPN11 ALK BRAF FGFR1 GNAS cKIT NRAS SMO FBXW7 RB1 APC CSF1R FGFR2 HRAS KRAS PDGFRA TP53 HNF1A SMAD4 ATM CTNNB1 FLT3 IDH1 cMET PIK3CA VHL JAK3 SMARCB1 STK11 In certain instances, some biomarkers included in the MI Profile, Next-Generation Sequencing Cancer Service or genes ordered individually will not associate with commercially available cancer therapies or clinical trials. * May not be available for Medicare patients. Medicare only reimburses BRCA1-2 for breast and ovarian cases only. Formalin Fixed Paraffin Embedded (FFPE) Samples Sufficient tumor must be present to complete all analysis. If you have any questions, please contact Client Services at (888) 979-8669. S P ECI ME N TY PE SP E C I M E N R E QU I R E M E N T S Fixed Tissue One (1) tumor-containing formalin fixed paraffin embedded block (FFPE) from most recent surgery or biopsy. Successive four (4) micron sections will be created from the block until sufficient material for the testing orders is obtained. For the molecular analysis, tumor cells will be excised by microdissection until a total area of at least 50mm2 is obtained. Core Needle Biopsy Four to six (4-6) biopsies formalin fixed paraffin embedded • 18 gauge needle preferred Fine Needle Aspirate (FNA) One (1) formalin fixed paraffin embedded block containing sufficient tumor Unstained Slides Unstained, positively charged, unbaked slides from one single, tumor-containing formalin fixed paraffin embedded block; 4 micron sections • MI Profile™ - 55 slides • Next-Generation Sequencing only - 15 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. Malignant Fluid One (1) formalin fixed paraffin embedded cell block containing sufficient tumor. Formalin Samples Sufficient tumor must be present to complete all analysis. If you have any questions, please contact Client Services at (888) 979-8669. S P E CI ME N TY PE SP E C I M E N R E QU I R E M E N T S Fresh Tissue Two (2) or more samples with a minimum thickness of ~3mm (height, width, length) and submit in 10% neutral buffered formalin. Core Needle Biopsy Four to six (4-6) biopsies • 18 gauge needle preferred Bone/Bone Metastasis Two (2) or more samples with minimum thickness of 3mm (height, width, length) and submit in 10% neutral buffered formalin (DO NOT DECALCIFY) Insufficient Specimen Quantity – Prioritization of Tests In the event that a specimen is received with an insufficient quantity of tissue or insufficient percent tumor required to perform the entire profile or individual tests indicated on the requisition, Caris Life Sciences® will fax the ordering physician the proposed list of tests. The physician may amend this list to include any tests that are offered within the test menu. The ordering physician should review the proposed list of tests within 72 hours in order to provide timely results. Please note: turnaround time may be longer for specimens with limited tissue. In certain circumstances, CMS requires that Caris Life Sciences® bill the hospital for the technical component and the clinical laboratory services component. For more information, please call (888) 979-8669. For a complete list of CPT codes, please visit www.CarisMolecularIntelligence.com/billing_information. 4610 South 44th Place, Suite 100 / Phoenix, Arizona 85040 / (888) 979-8669 / Fax: (866) 479-4925 / CLIA 03D1019490 / CAP 7195577 / ISO 15189:2012 – 3531.01 Caris MPI, Inc. d/b/a Caris Life Sciences ©2014 Caris Life Sciences. All rights reserved. TN0034 .5 / Revision December 18, 2014
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