What steps are necessary for submitting a colon tumor sample?
Submitting a Sample
When submitting a sample for the Oncotype DX® colon cancer assay, please choose the one block with both the greatest amount/area of invasive colon carcinoma/associated stroma.
All specimens must be labeled with S barcode labels from the Oncotype DX Specimen Collection and Transportation Kit Box for that patient.
While the Genomic Health laboratory can accept tumor blocks and unstained slides, blocks are preferred due to the frequent requirement for manual microdissection of the specimen consistent with clinical trial experience.
The pathology requirements for MMR testing are the same as the submission criteria for Oncotype DX Colon: at least 2 mm of invasive adenocarcinoma or mucinous carcinoma that is formalin fixed and embedded in a paraffin block.
Click on the PDFs below for detailed pathology guidelines.
Oncotype DX Assay Requisition Form Instructions
When submitting an Oncotype DX assay sample, please fill out each section of the Requisition Form. The PDF below contains an example of a completed form, as well as instructions.
International Customers
Genomic Health is able to accept specimens from outside the US for the Oncotype DX Colon Cancer Assay. In addition to all other requirements for these specimens, payment is required prior to processing.
Payment can be made by entering valid credit card information on the Requisition Form or by enclosing an international money order in US dollars.
A Customs Declaration is also required for the specimen to be accepted into the United States. A sample Customs Declaration can be found here. Oncotype DX Specimen Kits comply with international packaging regulations for diagnostic specimens (IATA 650 Packaging Instruction). Please contact Customer Service at +1-650-569-2080 in advance to discuss any special requirements.
Below are ordering/sample submission instructions for international customers.
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- Contact Genomic Health's Customer Service or by calling 001-650-569-2080, to receive Oncotype DX Requisition Forms and Specimen Collection and Transportation boxes to submit your patient's sample.
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- When you are ready to submit your patient's colon cancer specimen, complete the Oncotype DX Requisition Form. Pre-payment is required prior to the release of results. Acceptable forms of payment include credit card, bank wire transfer, or international money order in U.S. dollars. Please see the Billing section on the Requisition Form for more details.
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- Prepare and submit the specimen in the Specimen Collection and Transportation Kit. Enclose the Requisition Form with the specimen. Please see above for further specimen preparation details. Please note, if a tumor block is submitted, Genomic Health will not be responsible for any specimens retained or fees imposed by customs in your country during specimen return.
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- Send the specimen in the Oncotype DX specimen transportation box to Genomic Health via Federal Express (800-GO-FEDEX), using the pre-printed shipping Airway bill. A Customs Declaration and commercial invoice are required for the specimen to be accepted into the United States. Please include these documents along with the Federal Express Airway bill.
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- Results are, delivered via fax, overnight mail or secure online transfer generally within 7 to 10 days from the date laboratory processing begins. Please allow 1-2 additional days for MMR testing. Click here for more information on reports.
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Note: For physicians located in Australia, Brazil, Columbia, Costa Rica, Cyprus, Greece, Hong Kong, Hungary, India, Israel, Japan, Kuwait, Panama, Russia, South Africa, Spain, South Korea, Taiwan, Turkey, and Venezuela please contact Genomic Health's local partner in your country. You can receive partner information by contacting Customer Service at international@genomichealth.com or by calling +800 662 68973.
Specimens are analyzed in the United States. To submit a specimen, a Customs Declaration is required for the specimen to be accepted into the United States. A sample Customs Declaration can be found here. Oncotype DX Specimen Kits comply with international packaging regulations for diagnostic specimens (IATA 650 Packaging Instruction). Please contact Customer Service at 001-650-569-2080 in advance to discuss any special requirements.
Order Forms for International Customers
If this is your first time filling out any of our forms, call 001-650-569-2080 for more detailed information.
Order Supplies/Questions
Please contact Customer Service for any questions you may have when completing the Oncotype DX Requisition Form or how to submit a specimen:
Email: Customer Service
Domestic Phone: 866-ONCOTYPE (866-662-6897)
International Phone: +1-650-569-2080