FOUNDATIONONE CDx FFPE Tissue Shipping Kit Instructions
- June 5, 2024
- FOUNDATIONONE
Table of Contents
Specimen Instructions
FoundationOne®CDx is a broad companion diagnostic (CDx) test for multiple tumor types, including one pan-tumor indication. In addition, to use as a companion diagnostic, FoundationOne CDx provides cancer-relevant alterations that may inform patient management in accordance with professional guidelines. The information generated by this test is an aid in the identification of patients who are most likely to benefit from associated therapeutic products as noted in Table 1 of the Intended Use.
Acceptable Samples
- Formalin-fixed paraffin-embedded (FFPE) specimens, including cut slide specimens, are acceptable.
- Use standard fixation methods to preserve nucleic acid integrity. 10% neutral-buffered formalin for 6–72 hours is industry standard. DO NOT use other fixatives (Bouins, B5, AZF, Holland’s).
- Do not decalcify.
SAMPLE SIZE
- When feasible, please send the block + 1 H&E slide.
10 unstained slides (positively charged and unbaked at 4-5 microns thick) + 1 H&E slide.
-
For smaller samples, providing the original H&E will preserve material for testing.
SURFACE AREA-
MINIMUM: 25 mm2
If sending slides, provide 10 unstained slides cut at 4-5 microns thick to achieve a tissue volume of 1 mm3 .
Specimens with a smaller surface area may meet volume requirements by submitting additional unstained slides (USS) or blocks.
TUMOR CONTENT -
OPTIMUM: 30% TN MINIMUM: 20% TN
Percent tumor nuclei (%TN) = the number of tumor cells divided by the total number of all cells with nuclei
Note for liver specimens: higher tumor content may be required because hepatocyte nuclei have twice the DNA content of other somatic nuclei
-
Shipping Instructions
- Place the completed Foundation Medicine Test, Foundation Medicine Test Requisition Form, insurance information, and any other attachments into the FoundationOne CDx Specimen Shipping Kit.
- Place the specimen shipping kit (including samples and paperwork) into the provided FedEx shipping pack, first ensuring that primary specimen containers (e.g. blocks, slides) are labeled with two patient-specific identifiers. Seal the shipping pack.
- If using the shipping pack provided in this kit (recommended), recording the Kit ID # will allow you to properly track the specimen. If you use a different shipping pack, consider recording that pack’s tracking #.
- Call 800.463.3339 to request a pick-up or drop the package at your site’s designated FedEx pick-up location and ship a sealed shipping pack to:
Foundation Medicine, Inc.
150 Second Street
Cambridge, MA 02141
Phone: 888.988.3639
FoundationOne®CDx is a qualitative next-generation sequencing-based in vitro diagnostic test for advanced cancer patients with solid tumors and is for prescription use only. The test analyzes 324 genes as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for the labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For the complete label, including companion diagnostic indications and important risk information, please visit www.F1CDxLabel.com.
© 2020 Foundation Medicine, Inc.
Foundation Medicine® and FoundationOne® are trademarks of Foundation Medicine,
Inc.
www.foundationmedicine.com
Tel: 888.988.3639
Fax: 617.418.2290
US-FDX- 2000038 V2.0
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>