Foundation Medicine Wins Approval of Comprehensive Pan-Tumor Liquid Biopsy Test


With a new regulatory approval in hand for its comprehensive pan-tumor liquid biopsy test, Foundation Medicine said it plans for the product to be available for commercial use by Friday, Aug. 28.

This morning, Cambridge, Mass.-based Foundation Medicine announced the U.S. Food and Drug Administration (FDA) approved FoundationOne Liquid CDx, its new pan-tumor liquid biopsy test that is indicated for use as a companion diagnostic for four FDA-approved precision therapies. Those therapies include an indication for Clovis Oncology’s Rubraca (rucaparib), a PARP inhibitor approved by the FDA for treatment of metastatic castration-resistant prostate cancer patients with BRCA1/2 mutations, and three first-line EGFR-TKIs for the treatment of non-small cell lung cancer patients.

Liquid biopsies are becoming more important in the treatment of some cancers. One of the issues facing some patients is the location of a tumor in the body, which may make it difficult and highly invasive to take a tissue sample.

“For many patients, getting a tissue biopsy is not an option due to tumor location or the patient’s health status, or a patient may simply prefer not to have an additional procedure. Blood-based biomarker testing options can help to expand access to these actionable genomic insights in patients with advanced cancer,” Andrea Ferris, president and chief executive officer of LUNGevity Foundation said in a statement.

Through the use of a blood sample, FoundationOne Liquid CDx analyzes over 300 cancer-related genes for alterations. The results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies and, within its professional services section, delivers information about the genomic signatures micro-satellite instability and blood tumor mutational burden, as well as single-gene alterations, including all NTRK fusions, to help inform the use of other therapies including immunotherapies, the company said. The report also provides relevant clinical trial information and includes interpretive content developed in accordance with professional guidelines in oncology for patients with any solid tumor, Foundation Medicine added.

The FDA’s approval of FoundationOne Liquid CDx was based on analytical and clinical validation studies that included more than 7,500 samples and 30,000 unique variants across over 30 cancer types. Evaluation of the platform using multiple validation methods across a broad range of tumor types demonstrated high sensitivity and specificity, even at the low allele frequencies often observed in clinical blood samples.

Foundation Medicine Chief Medical Officer Brian Alexander said FoundationOne Liquid CDx underscores the company’s commitment to advance patient care across all cancer types by bringing forward multiple comprehensive genomic profiling options that are essential for high-quality cancer care.

“We believe that cancer patients and their physicians deserve the highest quality genomic testing to make informed decisions about personalized treatment,” Alexander said in a statement.

Alexander added that Foundation Medicine will seek additional companion diagnostic claims for FoundationOne Liquid CDx, which would broaden the use of the test in clinical practice if those claims are approved. Additionally, Alexander said FoundationOne Liquid CDx test is an important tool for the acceleration of drug development and for understanding mechanisms of resistance.


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