What steps are necessary?
Submitting a Sample
When submitting a sample for the Oncotype DX® assay, please choose the one block with both the greatest amount/area of invasive breast carcinoma/associated stroma and the least amount of non-invasive mammary epithelium (in situ carcinoma, hyperplastic epithelium, normal epithelium).
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.
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 Breast 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 001-650-569-2080 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 at customerservice@genomichealth.com 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 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 returned via online secure access, fax and priority mail, within 10 to 14 calendar days of specimen receipt.
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Note: For physicians located in Greece, Israel, Turkey, Japan and the United Kingdom, please contact Genomic Health's local partner in your country. You can receive partner information by contacting Customer Service at customerservice@genomichealth.com or by calling 001-650-569-2080.
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: customerservice@genomichealth.com
Domestic Phone: 866-ONCOTYPE (866-662-6897)
International Phone: 001-650-569-2080