BOSTON--(BUSINESS WIRE)--Foundation Medicine, Inc. today announced it was awarded its second consecutive, five-year contract by the U.S. Department of Veterans Affairs (VA) to provide tumor molecular profiling tests and services to eligible Veterans living with cancer as part of the VA’s National Precision Oncology Program. The national contract covers Foundation Medicine’s tissue-based test FoundationOne®CDx, liquid-based test FoundationOne®Liquid CDx, tissue-based RNA sequencing test FoundationOne®RNA and FoundationOne®Heme for hematologic malignancies.
Foundation Medicine’s high-quality diagnostic tests being provided to the VA accurately identify the genomic mutations driving a patient’s cancer and match a patient to the most effective treatment options, including targeted therapies, immunotherapies or clinical trials.
“We are honored to continue our relationship with the VA’s National Precision Oncology Program to provide Veterans with high-quality diagnostic testing,” said Annie Murphy, chief commercial officer at Foundation Medicine. “We know that delivering the right answers requires the confidence that tests reliably produce accurate results. Our comprehensive portfolio of tissue and blood-based tests can simplify complex decisions by generating quality information to enable better decision-making, patient outcomes and treatment options.”
Foundation Medicine was awarded its first contract by the VA in 2019 to provide FoundationOne CDx and FoundationOne®Liquid for solid tumors as well as FoundationOne Heme for hematologic malignancies.
Foundation Medicine and FoundationOne® are registered trademarks of Foundation Medicine, Inc.
About Foundation Medicine: Your Essential Partner in Cancer Care
Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on LinkedIn and X.
About FoundationOne®CDx
FoundationOne®CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. 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 a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit www.F1CDxLabel.com.
About FoundationOne®Liquid CDx
FoundationOne®Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for 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. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and genomic alteration status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.
About FoundationOne®RNA
FoundationOne®RNA is a laboratory developed test that was developed and its performance characteristics determined by Foundation Medicine. FoundationOne RNA has not been cleared or approved by the U.S. Food and Drug Administration. FoundationOne RNA is a test for solid tumors which utilizes RNA sequencing to interrogate 318 cancer-related genes to capture gene fusions and rearrangements. A negative result does not rule out the presence of an alteration. Genomic findings are not prescriptive or conclusive for labeled use of any specific therapeutic product.
About FoundationOne®Heme
FoundationOne®Heme is a laboratory developed test that was developed and its performance characteristics determined by Foundation Medicine. FoundationOne Heme has not been cleared or approved by the U.S. Food and Drug Administration. For more information on FoundationOne Heme, please see its Technical Specifications at foundationmedicine.com/heme.
The test employs RNA sequencing in addition to DNA sequencing to simultaneously detect all classes of genomic alterations, including base pair substitutions, insertions and deletions, copy number alterations and rearrangements, and gene fusions.
