FDA Approves FoundationOne Liquid CDx as Companion Diagnostic

The FDA approved the FoundationOne Liquid CDx based on analytical and clinical validation studies that included more than 7500 samples and 30,000 unique variants across over 30 cancer types.

The FDA has approved the FoundationOne Liquid CDx, a comprehensive pan-tumor liquid biopsy test, according to Foundation Medicine, the developer of the test.

The liquid biopsy test is now approved to identify patients who may benefit from treatment with specific FDA-approved targeted therapies, including an indication for rucaparib (Rubraca), a PARP inhibitor for the treatment of patients with BRCA 1/2-mutant metastatic castration-resistant prostate cancer, and 3 first-line tyrosine kinase inhibitors (TKIs) for the treatment of non-small cell lung cancer (NSCLC).

“We believe that cancer patients and their physicians deserve the highest quality genomic testing to make informed decisions about personalized treatment,” Brian Alexander, MD, MPH, chief medical officer at Foundation Medicine, said in a press release. “Created from our scientific expertise and pioneering spirit, FoundationOne Liquid CDx underscores our commitment to advance patient care across all cancer types by bringing forward multiple FDA-approved comprehensive genomic profiling options that are increasingly essential for high-quality cancer care.”

“We are seeking additional companion diagnostic claims for FoundationOne Liquid CDx, which, if approved, would further enhance utility of the test in clinical practice,” Alexander continued. “Additionally, this test is an important tool for the acceleration of drug development and for understanding mechanisms of resistance.”

In addition to acting as a companion diagnostic, the FoundationOne Liquid CDx also acts as a comprehensive genomic profiling test that reports genomic alteration results, including genomic signatures such as blood tumor mutational burden and high microsatellite instability, as well as single gene alterations, including all NTRK fusions, for patients with any solid tumor to further aid in patient care.

The approval of FoundationOne Liquid CDx was based on analytical and clinical validation studies that included more than 7500 samples and 30,000 unique variants across over 30 cancer types. The platform was evaluated using multiple validation methods across a wide range of tumor types, demonstrating high sensitivity and specificity even at low allele frequencies often observed in clinical blood samples.

The high throughput hybridization-based capture technology is able to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of patients with advanced cancer. Overall, the test is approved to report short variants in 311 genes.

Notably, use of the test does not guarantee that a patient will be matched to a treatment. Moreover, if a patient receives a negative result for companion diagnostic mutations, it does not mean that the presence of an alteration can be ruled out.

“Liquid biopsies are becoming an increasingly important option to inform personalized treatment decisions for physicians treating certain advanced cancer patients who require minimally invasive solutions to genomic testing,” Mark Socinski, MD, executive director of Thoracic Cancer and medical oncologist at the AdventHealth Cancer Institute in Orlando, Florida, said in the release. “This approval helps expand access to important genomic information needed for physicians to make more informed decisions about targeted treatment approaches for their patients and is another important step toward making comprehensive genomic testing a part of routine clinical cancer care.”

The FoundationOne Liquid CDx will be commercially available on Friday, August 28 and is covered across all solid tumors for eligible Medicare and Medicare Advantage beneficiaries in accordance with the Centers for Medicare and Medicaid Services National Coverage Decision Memo criteria, according to Foundation Medicine.


FDA Approves Foundation Medicine's FoundationOne®Liquid CDx, a Comprehensive Pan-Tumor Liquid Biopsy Test with Multiple Companion Diagnostic Indications for Patients with Advanced Cancer [news release]. Cambridge, Massachusetts. Published August 26, 2020. Accessed August 27, 2020. https://www.foundationmedicine.com/press-releases/445c1f9e-6cbb-488b-84ad-5f133612b721

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