Order Form - Response Genetics

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