FOUNDATION MEDICINE FoundationOne Heme Specimen Instructions

FOUNDATION MEDICINE FoundationOne Heme Specimen Instructions

Specimen Instructions

Fresh Specimens (Peripheral Whole Blood or Bone Marrow Aspirate)

STEP 1

Ensure that you are utilizing the correct kit for the patient:

• Yellow kits are for FoundationOne®Heme blood or bone marrow aspirate
• Accepted tumor types for FoundationOne Heme Fresh kits are leukemias and lymphomas, including myelodysplastic syndromes (MDS) and myeloproliferative neoplasms (MPN).

STEP 2

Ensure that your sample meets our specimen requirements:
Neoplastic/lesional cells must constitute at least 20% of nucleated cellular elements
(tumor content will be determined based on cytomorphologic review in conjunction with other supporting laboratory results when appropriate).

STEP 3

Understand your timeline:
All FoundationOne Heme fresh samples (peripheral blood and bone marrow aspirate) must be
received the day after collection for optimal analysis , as sensitivity of detection may degrade with time. If procuring samples on Friday, please FedEx priority overnight and specify Saturday delivery on the shipping label to ensure timely receipt.

STEP 4

Collect the specimen. Specimens must NEVER be frozen prior to submission.

STEP 5

Package and mail the specimen(s) to the Foundation Medicine laboratory. Each kit should be utilized for one patient. Do not include different patient samples in the same box.

Shipping Instructions

7. Remove the kit tracking information card and keep for your
8. Place each tube inside the provided absorbent Ziploc®
9. Place the tube(s) back into the foam insert inside the yellow (If submitting bone marrow aspirate, only the lavender-top EDTA tube is required.)
10. Put the completed Test Requisition Form into the yellow box. (Alternatively, email it to Client Services or submit your order online).
11. If the patient has Medicare as his/her primary insurance, fill out an Advanced Beneficiary Notice (ABN) and put into the yellow box. (Completed ABN forms may also be sent to Foundation Medicine via fax at 283.5838 or emailed to myABN@foundationmedicine.com)
12. If readily available, put concurrent or recent laboratory test results (e.g. CBC/differential, flow cytometry results, final bone marrow pathology report) into the yellow (These documents also may be emailed or faxed to Client Services or uploaded via our online portal.)
    • NOTE: Mobile Phlebotomists do not need to collect and submit the test requisition form, ABN, or other laboratory
13. Place the yellow box into the provided clinical shipping
14. Call 463.3339 to request a pick-up. Otherwise, drop the package at your site’s designated FedEx pick-up location.
15. Ship via FedEx overnight, ambient temperature. Refer to step 3 regarding timelines for
16. Packets should be shipped to:

Foundation Medicine, Inc. 7010 Kit Creek Road Morrisville, NC 27560 Phone: 888.988.3639

SAMPLE TYPE

FFPE BLOCK OR 16 UNSTAINED SLIDES (+ 1 H&E SLIDE)
Tissue should be formalin-fixed and embedded into a paraffin block. Use standard fixation methods with 10% neutral-buffered formalin. DO NOT use other fixatives (AZF, B5, Bouin’s, Holland’s). If sending slides, send 16 unstained slides (charged and unbaked, with tissue cut at a 5 micron thickness), plus 1 H&E slide.

SURFACE AREA

OPTIMUM: 5 × 5 mm2
Tissue should have a surface area of at least 25 mm2 (5 x 5 mm2, 2.5
x 10 mm2).

OPTIMUM: 2 mm3

Optimal sample volume can be achieved by sending optimal tissue surface area (25 mm2) at a depth of
³80 microns. For suboptimal tissue surface area, additional depth is required.

DNA is extracted from nucleated cells. Samples with low nucleated cellularity (e.g., those with abundant mature erythrocytes, lesional cells that contain excessive cytoplasm, or tissue with extensive associated fibrosis) may require greater tissue volume to yield sufficient DNA at extraction

MINIMUM: ³20%

If the ratio of nucleated malignant to nucleated non-malignant cells is too low, sensitivity of detection of certain classes of alterations is reduced. High tumor content is preferable.
Note for liver specimens: Higher tumor content may be required because hepatocyte nuclei have twice the DNA content of other somatic nuclei.

Shipping Instructions

1. Remove the kit tracking information card and keep for your records
2. Label each primary specimen container (e.g. blocks, slides) with two patient-specific identifiers (e.g. name and date of birth).
3. Put the completed test requisition form into the orange box. (Alternatively, email it to Client Services or submit your order online).
4. If readily available, put concurrent or recent laboratory test results (e.g. pathology report) into the orange (These documents also may be emailed or faxed to Client Services or uploaded via our online portal.
5. Place the orange box into the provided clinical shipping
6. Call 800.463.3339 to request a pick-up. Otherwise, drop the package at your site’s designated FedEx pick-up

Foundation Medicine, Inc. 7010 Kit Creek Road Morrisville, NC 27560
Phone: 888.988.3639

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References

• FoundationOne Heme | Foundation Medicine
• Foundation Medicine | A World-leading Molecular Insights Company

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