FoundationOne® Heme
Use
FoundationOne Heme is a comprehensive genomic profiling (CGP) test that combines DNA and RNA sequencing to detect known, novel, and complex fusion events as well as substitutions, indels, and CNVs. It is designed for patients with hematologic malignancies and solid tumors, with the aim of identifying potential targeted therapy options, detecting alterations in prognostic genes, and sub-classifying diagnoses. This test can provide valuable insights for treatment strategies by broad coverage across guideline-recommended genes in leukemias and MDS.
Special Instructions
FoundationOne Heme is validated for a wide variety of sample types including FFPE tissue, peripheral whole blood, and bone marrow aspirate, accommodating different clinical scenarios. The test includes comprehensive fusion profiling for BCR-ABL1-like B-ALL classification and provides Variant Allele Frequency (VAF) % to support clinical interpretation.
Limitations
This laboratory developed test (LDT) has not been cleared or approved by the U.S. Food and Drug Administration. While it provides broad genomic coverage, the test's detection might vary for certain genomic alterations, such as low-frequency variants or complex rearrangements, across different sample types. FoundationOne Heme might not cover all possible cancer-related genes, and the results are not prescriptive for specific therapies.
Methodology
NGS (CGP)
Biomarkers
Result Turnaround Time
14 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided