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FoundationOne® Heme
Clinical Genetic Test
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offered by
Foundation Medicine, Inc.
View lab's test page
LinkOut
GTR Test Accession: Help GTR000527977.1
NYS CLEP
CANCER
Registered in GTR: 2015-08-31
View version history
Last annual review date for the lab: 2022-07-08 Past due LinkOut
At a Glance
Test purpose: Help
Therapeutic management
Conditions (2): Help
Hematologic neoplasm; Sarcoma
Genes (405): Help
ABL1 (9q34.12); ACTB (7p22.1); ADGRA2 (8p11.23); AKT1 (14q32.33); AKT2 (19q13.2) more...
Methods (4): Help
Molecular Genetics - Deletion/duplication analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS); ...
Target population: Help
Patients diagnosed with hematologic malignancies or sarcomas
Clinical validity: Help
Clinical validity for base substitutions, short insertions and deletions (indels), …
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Foundation Medicine, Inc.
View lab's website
View lab's test page
Test short name: Help
F1H
Specimen Source: Help
Who can order: Help
  • Licensed Physician
How to Order: Help
To order F1H please download the requisition form, complete all of the information requested and fax it along with the pathology report and insurance information to (617) 418-2290. Alternatively, set up an account by completing an online account request. If sending peripheral blood or bone marrow aspirate, please follow the …
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Order URL
Test service: Help
Clinical Testing/Confirmation of Mutations Identified Previously
Foundation ACCESS program
    Comment: Matches patients to open clinical trials
Test development: Help
Test developed by laboratory but exempt from FDA oversight (eg. NYS CLEP approved, offered within a hospital or clinic)
Informed consent required: Help
Based on applicable state law
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Test Order Code, Lab contact for this test, Contact policy, Test strategy
Conditions Help
Total conditions: 2
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 405
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 4
Method Category Help
Test method Help
Instrument
Deletion/duplication analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Illumina HiSeq 2500
RNA analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Illumina HiSeq 2500
Sequence analysis of select exons
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Illumina HiSeq 2500
Sequence analysis of the entire coding region
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Illumina HiSeq 2500
Clinical Information
Test purpose: Help
Therapeutic management
Clinical validity: Help
Clinical validity for base substitutions, short insertions and deletions (indels), copy number alterations and selected fusions across 405 cancer-related genes was established along with RNA sequencing across 265 genes to capture a broad range of gene fusions. The performance characteristics were determined using 3,824 routine formalin-fixed and paraffin-embedded (FFPE) clinical … View more
View citations (1)
  • Submitted for publication.
Target population: Help
Patients diagnosed with hematologic malignancies or sarcomas
View citations (7)
  • Giulino-Roth L, Wang K, MacDonald TY, Mathew S, Tam Y, Cronin MT, Palmer G, Lucena-Silva N, Pedrosa F, Pedrosa M, Teruya-Feldstein J, Bhagat G, Alobeid B, Leoncini L, Bellan C, Rogena E, Pinkney KA, Rubin MA, Ribeiro RC, Yelensky R, Tam W, Stephens PJ, Cesarman E. Targeted genomic sequencing of pediatric Burkitt lymphoma identifies recurrent alterations in antiapoptotic and chromatin-remodeling genes. Blood. 2012;120(26):5181-4. doi:10.1182/blood-2012-06-437624. Epub 2012 Oct 22. PMID: 23091298.
  • Sharman JP, Chmielecki J, Morosini D, Palmer GA, Ross JS, Stephens PJ, Stafl J, Miller VA, Ali SM. Vemurafenib response in 2 patients with posttransplant refractory BRAF V600E-mutated multiple myeloma. Clin Lymphoma Myeloma Leuk. 2014;14(5):e161-3. doi:10.1016/j.clml.2014.06.004. Epub 2014 Jun 11. PMID: 24997557.
  • Chiron D, Di Liberto M, Martin P, Huang X, Sharman J, Blecua P, Mathew S, Vijay P, Eng K, Ali S, Johnson A, Chang B, Ely S, Elemento O, Mason CE, Leonard JP, Chen-Kiang S. Cell-cycle reprogramming for PI3K inhibition overrides a relapse-specific C481S BTK mutation revealed by longitudinal functional genomics in mantle cell lymphoma. Cancer Discov. 2014;4(9):1022-35. doi:10.1158/2159-8290.CD-14-0098. Epub 2014 Jul 31. PMID: 25082755.
  • Chalmers ZR, Ali SM, Ohgami RS, Campregher PV, Frampton GM, Yelensky R, Elvin JA, Palma NA, Erlich R, Vergilio JA, Chmielecki J, Ross JS, Stephens PJ, Hermann R, Miller VA, Miles CR. Comprehensive genomic profiling identifies a novel TNKS2-PDGFRA fusion that defines a myeloid neoplasm with eosinophilia that responded dramatically to imatinib therapy. Blood Cancer J. 2015;5(2):e278. doi:10.1038/bcj.2014.95. Epub 2015 Feb 06. PMID: 25658984.
  • Wang HY, McMahon C, Ali SM, Young LE, Yekezare S, Ross JS, Ball ED. Novel FNDC3B and MECOM fusion and WT1 L378fs* 7 frameshift mutation in an acute myeloid leukaemia patient with cytomorphological and immunophenotypic features reminiscent of acute promyelocytic leukaemia. Br J Haematol. 2016;172(6):987-90. doi:10.1111/bjh.13552. Epub 2015 Jul 06. PMID: 26147192.
  • Detection of novel and potentially actionable anaplastic lymphoma kinase (ALK) rearrangement in colorectal adenocarcinoma by immunohistochemistry screening. Lee J, et al. Oncotarget. 2015;6(27):24320-32. doi:10.18632/oncotarget.4462. PMID: 26172300.
  • Heuck CJ, Jethava Y, Khan R, van Rhee F, Zangari M, Chavan S, Robbins K, Miller SE, Matin A, Mohan M, Ali SM, Stephens PJ, Ross JS, Miller VA, Davies F, Barlogie B, Morgan G. Inhibiting MEK in MAPK pathway-activated myeloma. Leukemia. 2016;30(4):976-80. doi:10.1038/leu.2015.208. Epub 2015 Jul 31. PMID: 26228812.
Sample reports:
Sample Negative Report Help
Sample Negative Report

Sample Positive Report Help
Sample Positive Report
Recommended fields not provided:
Clinical utility, What is the protocol for interpreting a variation as a VUS?, Are family members with defined clinical status recruited to assess significance of VUS without charge?, Will the lab re-contact the ordering physician if variant interpretation changes?, Is research allowed on the sample after clinical testing is complete?
Technical Information
Test Procedure: Help
FoundationOne® Heme is designed to analyze and interpret sequence information for somatically altered genes in human hematologic malignancies (leukemias, lymphomas, and myelomas), many sarcomas and some pediatric cancers. Genes included in this assay encode known or likely targets of therapies, either approved or in clinical trials, or are otherwise known … View more
Test Platform:
None/not applicable
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Analytical validity for base substitutions, short insertions and deletions (indels), copy number alterations and selected fusions across 405 cancer-related genes was established along with RNA sequencing across 265 genes to capture a broad range of gene fusions. The performance characteristics were determined using 76 routine formalin-fixed and paraffin-embedded (FFPE) clinical … View more
View citations (1)
  • Submitted for publication.
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Intra-Laboratory

Description of PT method: Help
Because no approved proficiency testing programs exist for FoundationOne Heme, internal proficiency testing (IPT) is conducted per Massachusetts State Regulation 180.450 and 180.455, CUA 493.801 and 493.1236, and CAP General Laboratory Checklist guideline# Lab Gen.1000-13032. Test method accuracy, turn-around-time and personnel proficiency is confirmed through IPT. Procedure description: A number … View more
Recommended fields not provided:
Test Confirmation, Assay limitations, Description of internal test validation method, PT Provider, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
NYS CLEP Approval: Help
Number: 8686
Status: Approved
Additional Information
Practice guidelines:
Consumer resources:

IMPORTANT NOTE: NIH does not independently verify information submitted to GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.