UnitedHealthcare Provides Commercial Coverage for FoundationOne CDx and FoundationOne Liquid CDx in Multiple Companion Diagnostic Indications

Foundation Medicine, a pioneer in molecular profiling for cancer, announced that UnitedHealthcare commercial plans will cover FoundationOneCDx as a companion diagnostic in all solid tumors for patients with unresectable or metastatic cancer being considered for treatment with an immune checkpoint inhibitor and meeting coverage criteria. Additionally, FoundationOneLiquid CDx will be covered as a companion diagnostic for patients with advanced breast cancer, metastatic non-small cell lung cancer (NSCLC), recurrent ovarian cancer and metastatic castrate-resistant prostate cancer (mCRPC) meeting coverage criteria. Coverage is effective April 1, 2023. FoundationOne CDx, a tissue-based comprehensive genomic profiling (CGP) test, and FoundationOne Liquid CDx, a CGP liquid biopsy test, are used to identify patients who may benefit from treatment with specific FDA-approved targeted therapies.

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“UnitedHealthcare’s coverage decision will improve patient access to molecular profiling and enable better outcomes for patients.”

“We believe patients and their physicians deserve the highest quality genomic testing to make informed decisions about personalized treatment,” said Foundation Medicine Chief Executive Officer Brian Alexander, M.D., M.P.H. “UnitedHealthcare’s coverage decision will improve patient access to molecular profiling and enable better outcomes for patients.”

UnitedHealthcare’s planned coverage of FoundationOne CDx and FoundationOne Liquid CDx is in addition to coverage that Foundation Medicine already has for these tests from other national and regional commercial providers, as well as by Medicare and Medicare Advantage plans.

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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.

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.

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 mutation status confirmed using an FDA-approved tumor tissue test, if feasible.

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