FDA Approves Comprehensive Multi-Tumor Liquid Biopsy Test FoundationOne Liquid CDx for Solid Tumors


The test was also approved as a companion diagnostic test to determine which select patients with metastatic castration-resistant prostate cancer could benefit from Rubraca, as well as for three frontline TKIs in patients with non-small cell lung cancer.

The Food and Drug Administration (FDA) approved FoundationOne Liquid CDx, a comprehensive multi-tumor liquid biopsy test, for all solid tumors with multiple companion diagnostic indications, according to the biopsy test’s developer Foundation Medicine.

FoundationOne Liquid CDx was also approved as a companion diagnostic test to determine which patients will benefit from FDA-approved targeted therapies, including Rubraca (rucaparib) for select patients with BRCA1/2-mutated metastatic castration-resistant prostate cancer, and three frontline tyrosine kinase inhibitors in non-small cell lung cancer.

“We believe that cancer patients and their physicians deserve the highest quality genomic testing to make informed decisions about personalized treatment,” said Foundation Medicine’s chief medical officer Dr. Brian Alexander in a company-issued press release. “We are seeking additional companion diagnostic claims for FoundationOne Liquid CDx, which, if approved, would further enhance utility of the test in clinical practice. Additionally, this test is an important tool for the acceleration of drug development and for understanding mechanisms of resistance.”

The agency based its approval on data from validation and analytical studies that included more than 7,500 samples and 30,000 unique variants across more than 30 cancer types. The data, according to the release, showed high sensitivity and specificity.

“From a clinical perspective, I believe physicians should discuss tumor genomic profiling with every metastatic prostate cancer patient to inform the use of targeted and immunotherapies,” said Dr. Neeraj Agarwal, director of the Genitourinary Oncology Program at the Huntsman Cancer Institute in Salt Lake City, Utah. “This approval addresses the need for blood-based genomic testing options when tissue can be challenging to obtain.”

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