Response Genetics, Inc. 1640 Marengo Street, Los Angeles, CA 90033 Tel 888.700.7110 • Fax 323.224.3096 www.responsegenetics.com TEST REQUISITION FORM Highlighted areas are required Patient Information Ordering Physician Information Last Name First name MI Ordering Physician Male Female Street Address Practice Name City, State, Zip Street Address NPI DOB Email/Fax City, State, Zip Country Social Security # Phone Phone Fax STATEMENT OF MEDICAL NECESSITY. This test is medically necessary in the management of this patient. MEDICAL RECORDS/PATIENT HISTORY REQUEST - CORRESPONDENCE/APPEALS Pathology Specimen (SUBMIT COPY OF PATHOLOGY REPORT) Pathologist Fax Pathology Dept. Phone Fax Contact Person Affiliated Hospital Group(s) The undersigned certifies that he/she is licensed to order the test(s) listed above and that such test(s) are necessary for the care or treatment of the above-referenced patient. Specimen Block ID/Patient Pathology # Patient’s Medical Record # Physician/Authorized Signature Retrieved From Archive Date Collection Date Diagnosis(es) ICD-9 Staging/Grade Billing Information Bill: Email Address Body Site Primary Date (mm/dd/yyyy) Does this patient give consent to the use of his/her sample for research? Yes No Consent is implied if box is not marked Metastatic Insurance (SUBMIT COPY OF INSURANCE CARD) Medicare Medicaid Hospital Patient Status: Inpatient Outpatient Non-Hospital Patient Client Secondary Insurance: Yes No *Self-Pay If yes, please attach secondary insurance form Specify Group to be Billed: SERVICE LEVEL - For FISH testing Medicare #: Pre-Benefit Screening:: Select service level for FISH testing (ALK, ROS1, MET, HER2, RET & FGFR1) checked below. Automatic test reflexes are available with global orders only. For tech-only orders, clients must call to initiate add-ons. No *Name on Credit Card: *Credit Card Number: TECH-ONLY (Without interpretation) GLOBAL (With interpretation) Yes *Expiration Date: *CVC# *Billing Zip Code: ResponseDX: Tissue of Origin™ Testing Service TISSUE OF ORIGIN TEST (Formerly the Pathwork Tissue of Origin Test) As needed, may include Tissue of Origin Endometrial Test or Tissue of Origin Head & Neck Test, at no additional charge ResponseDX: Biomarkers LUNG CANCER Automatic reflex to comprehensive lung profile if driver profile results are all negative Driver Profile: EGFR Mutation, ALK (FISH), ROS1 (FISH) Expanded Driver Profile: EGFR Mutation, ALK (FISH), ROS1 (FISH), BRAF, RET (FISH), MET (FISH), HER2 Mutation Basic Lung Profile: EGFR, ERBB2 (HER2), BRAF, DDR2, KRAS, ALK, AKT1, HRAS, JAK2, KDR, MAP2K1, NOTCH1, NRAS, NTRK1, NTRK2, NTRK3, PIK3CA, PIK3R1, PIK3R2, PTEN, PTPRD, CDKN2A, TP53 (NGS) COMPREHENSIVE LUNG PROFILE: EGFR, ERBB2 (HER2), BRAF, DDR2, KRAS, ALK (point mutations only; translocations require separate FISH test), AKT1, HRAS, JAK2, KDR, MAP2K1, NOTCH1, NRAS, NTRK1, NTRK2, NTRK3, PIK3CA, PIK3R1, PIK3R2, PTEN, PTPRD, CDKN2A, TP53 (NGS) / ALK, ROS1, RET, MET, FGFR1 (FISH) / ERCC1, TS, RRM1, EGFR, cMET (RNA Expression) EGFR Mutation RET (FISH) KRAS Individual Markers (or add to Basic or Driver Profiles): ALK Break Apart FISH negative results will be reflexed to EML4-ALK (PCR) Check this box if you DO NOT want automatic reflex ALK (FISH) MET (FISH) HER2 Mutation EML4-ALK (PCR) PI3K EGFR Expression ROS1 (FISH) TS cMET Expression ROS1 (PCR) ERCC1 FGFR1 (FISH) BRAF RRM1 COLON CANCER Driver Profile: KRAS Mutation, NRAS Mutation, BRAF Mutation and MSI COMPREHENSIVE COLON PROFILE: KRAS, BRAF, EGFR Expression, PI3K, TS, ERCC1, UGT1A1, NRAS, MSI, VEGFR2, MET (done by FISH) Individual Markers (or add to Driver Profiles): If KRAS negative (Wild Type), reflex to BRAF Lynch Syndrome Testing: MSI (PCR) GASTRIC CANCER (Includes GE Junction) KRAS UGT1A1 MELANOMA Individual Markers Individual Markers BRAF NRAS cKIT HER2 (FISH) ERCC1 cKIT (for GIST Tumors) TS EGFR Expression MSI PI3K VEGFR2 TS MET (FISH) ERCC1 MMR Profile by IHC (MLH1, MSH6, PMS2) Melanoma Profile BRAF, NRAS, cKIT Gastric Profile - HER2 (FISH), ERCC1, cKIT, TS BRAF NRAS THYROID CANCER BRAIN CANCER Thyroid Profile - BRAF, RET (FISH), KRAS, NRAS Individual Markers BRAF RET (FISH) IDH1/IDH2 MGMT BRAF P13K KRAS cKIT ALK (FISH) HER2 (FISH) Breast Profile - ER, PR, HER2 (FISH) Reflex to HER2 (IHC) if HER2 (FISH) is equivocal KRAS NRAS EGFRvIII 1p/19q Individual Markers (or add to profile) HER2 (FISH) HER2 (IHC) ER (IHC) PR (IHC) Ki-67(IHC) PTEN (IHC) FGFR1 (FISH) PI3K RGI Internal Use Only OTHER TUMOR TYPES and PROFILES EGFR Mutation HER2 Mutation BREAST CANCER Brain Profile - IDH1/IDH2, MGMT, EGFRvIII, 1p/19q KI-67 (IHC) ROS1 RET (FISH) PTEN (IHC) MET (FISH) NRAS AML / MDS NGS LEUKEMIA PROFILE* *Includes the following markers by NGS: ABL, ASXL1, BCOR, CBL, CBLB, CEBPA, CREBBP, CSF3R, DNMT3A, ETV6, EZH2, FBXW7, FLT3, GATA1, GATA2, HRAS, IDH1, IDH2, IKZF1, IL7R, JAK1, JAK2, JAK3, KDM6A/UTX, KIT, KRAS, MLL, MPL, NOTCH1, NPM1, NRAS, PAX5, PTPN11 (SHP2), RUNX1, SF3B1, SRSF2, STAT3, SUZ12, TET2, TP53, U2AF35 (U2AF1), WT1, ZRSR2 SOLID TUMOR GENOTYPING PROFILE* *Includes the following markers by NGS: AKT1, AKT2, AKT3, ALK (point mutations only; translocations require separate FISH test), BRAF, CDNK2A, CDK4, DDR2, EGFR, ERBB2 (HER2), FGFR1, FGFR3, GNAQ, GNA11, GNAS, HRAS, KDR, KRAS, KIT, MAP2K1 (MEK1), MET, NTRK2, NTRK3, NF1, NOTCH1, NRAS, PI3KCA, PIK3R1, PTEN, RAC1, RB1, RET, STK11, TP53, TSC1, TSC2, VHL Response Genetics, Inc. proprietary document. Unauthorized use or distribution without prior consent is prohibited. ©August 2014 Received: Initials _____________________________ Date ____________________Time_________________ Path Rep. Insurance Specimen/Sample ID: __________________________ No. of Paraffin Block(s)__________ Slides___________ Unstained____________ Sections_________ H & E __________ ACC#___________________________________ REQ ID__________________________________ AC1002F1L ResponseDX Form Specimen Requirements In order to perform the analysis for the ordering physician, we require the following: 1. A formalin fixed, paraffin embedded (FFPE) block containing the patient’s tumor tissue (Please include address for returning the block) OR 2. For each non-FISH molecular test (including the ResponseDX: Tissue of Origin Test): • One unbaked, unstained 4 micron section on a positively charged glass slide for H&E staining. Label slide(s) as 4 microns. • 10 unbaked, unstained, 10 micron sections on positively charged glass slides. For small biopsies where total tissue area is < 5 mm x 5 mm, pplace two sections on each slide. • Air dry—do not oven dry • Do not use coverslips 3. For each FISH ordered: • Cut 3 tissue sections at 4 microns. Label slides as 4 microns and mount on positively charged glass slides • Air dry • Do not bake, deparaffinize, stain, or cover slip 4. For each Next-Generation Sequencing Test • 15 unbaked, unstained 5 micron sections on positively charged glass slides. For small biopsies where total tissue area is <5mm x 5mm, place two sections on each slide. • Air dry • Do not bake, deparaffinize, stain, or cover slip Important: Specimens suspected of contamination with Mad Cow Disease or Creutzfeldt-Jakob Disease (or any other prion disease) will not be accepted. Shipping Information Please include a copy of the pathology report. If you have any questions concerning the processing of this request, please call Customer Support at 323.224.3900 or 888.700.7110 Ship all specimens to: Response Genetics, Inc. 1640 Marengo Street, Suite 410 Los Angeles, CA 90033 Tel. 323.224.3900 888.700.7110 Fax 323.224.3096
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