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Test Code FND1HSO FoundationOne HEME

Important Note

For internal ordering only. Not available to outreach clients.

Useful For

FoundationOne Heme is a laboratory developed test (LDT) that combines DNA and RNA sequencing for patients with hematologic malignancies, sarcomas, or solid tumors where RNA sequencing is desired.

Synonyms/Keywords

Hematologic Malignancies

Sarcomas

Solid Tumors

Tumor Mutational Burden (TMB)

Microsatellite Instability (MSI)

Specimen Requirements

Fasting Required Specimen Type Preferred Container/Tube
No Varies

FoundationOne HEME Kit: Supplied in Specimen Lab Processing Department.

Refer to the Kit and the Collection Processing Instructions (below).

Acceptable Specimen Types

FoundationOne Heme is validated on multiple sample types: peripheral whole blood, bone marrow aspirate, extracted DNA/RNA, and formalin-fixed paraffinembedded (FFPE) tissuewith a minimum tumor/lesional content of 20% for optimal analysis.

Collection/Processing Instructions

  1. Ensure that you are utilizing the correct kit for the patient. Each kit should be utilized for one patient. Do not include different patient samples in the same box.
  2. Follow the collection and shipping directions included in the test kit.
  3. Fresh samples (peripheral blood and bone marrow aspirate) must arrive at the testing lab within 24 hours of sample collection.

If procuring samples on Friday, please FedEx priority overnight and specify Saturday delivery on the shipping label to ensure timely receipt.

 

PERIPHERAL WHOLE BLOOD: Collect 2.5 mL EDTA Lavender Top Tube (LTT) AND 2.5 mL blood in one PAXgene blood RNA tube (this needs to be sent with the EDTA Lavender Top Tube but should ALWAYS be the last tube drawn). 

 

BONE MARROW ASPIRATE:   Discard the PAXgene collection tube in kit.  Collect one 2.5 mL bone marrow aspirate in EDTA Lavender Top Tube (LTT).

 

FFPE Specimens (Block or Slides): Tumor content should be >20% for optimal analysis.  Ship at Room Temperature. ***DO NOT FREEZE***

Specimen Stability Information

Refer to Kit and Collection Processing Instructions

Rejection Criteria

Frozen specimens; specimens that have been frozen.

Test Components

Includes results from genomic signatures:

Tumor Mutational Burden (TMB)

Microsatellite Instability (MSI)

Test Information

FoundationOne Heme is a comprehensive genomic profiling (CGP) test combining DNA and RNA sequencing for patients with hematologic malignancies, sarcomas or solid tumors where RNA sequencing is desired. FoundationOne Heme detects known, novel, and complex fusion events as well as other common genomic alterations (substitutions, indels, and CNVs). This laboratory developed test (LDT) can be used by physicians to identify potential targeted therapy options, detect alterations in prognostic genes, and sub-classify sarcoma diagnoses.

  • Identifies the four main classes of genomic alterations (base substitutions, insertions and deletions, copy number alterations, and rearrangements).
  • Sequences RNA of 265 genes commonly rearranged in cancer to better identify known and novel gene fusions.
  • Sequences DNA to a median depth of ~500X unique coverage and RNA to an average of ~6.9 million unique pairs.

Interpretations

An interpretive report will be provided

Reference Range Information

An interpretive report will be provided

Performing Laboratory Name

Foundation Medicine

Marshfield Labs Performing Department

Sendout

Referral Laboratory Information

Address Telephone Website Link Marshfield Lab Account #

150 Second Street 

Cambridge, MA 02141

 888-988-3639

https://www.foundationmedicine.com

https://www.foundationmedicine.com/test/foundationone-heme

  

Performing Information

Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
Foundation Medicine, Inc   Sunday through Saturday 14 days Hybrid capture-based next-generation sequencing

CPT Codes

CPT Modifier
(if needed)		 Quantity Description Comments
81455   1 Targeted genomic sequence analysis panel, solid organ or hematolymphoid neoplasm, DNA analysis, and RNA analysis, when performed, 51 or greater genes  

Ordering Applications

Ordering Application Description
COM FoundationOne HEME
Cerner FoundationOne HEME