FDA Approves Companion Diagnostic Device FoundationOne Liquid CDx for Patients with Prostate Cancer

The FDA approved this liquid biopsy to check blood for prostate-tumor DNA that indicates the presence of genetic mutations or rearrangements. The test was also recently approved for use in patients with ovarian, non-small cell lung or breast tumors.

The Food and Drug Administration (FDA) approved FoundationOne Liquid CDx, a liquid biopsy that analyzes cancer DNA circulating in the blood to look for genetic mutations or alterations, as a companion diagnostic device for patients with metastatic castration-resistant prostate cancer who are eligible for treatment with Lynparza (olaparib).

The test, developed by Foundation Medicine, Inc., can specifically identify mutations in BRCA1, BRCA2 and ATM genes in this specific patient population, according to an alert from the FDA. It works by analyzing more than 300 cancer-related genes for genomic alterations that may make cancer treatable with targeted drugs or other novel therapies.

“With this latest companion diagnostic approval, physicians now have the option to choose either tissue or liquid-based comprehensive genomic testing based on their patients’ need and condition,” Foundation Medicine’s chief medical officer, Dr. Brian Alexander, said in a company-issued press release.

“Since tissue availability can be an issue for some patients with metastatic prostate cancer, blood-based testing is an important option to consider and critically important for informing patient care. The approval of this companion diagnostic will allow more patients to access genomic testing, regardless of specimen type, and provide oncologists with another tool to guide personalized treatment decisions.”

This approval comes shortly after another FDA approval on Oct. 26 for several indications for this same test:

  • to identify BRCA1 and BRCA2 gene mutations in patients with ovarian cancer who are eligible for treatment with Rubraca (rucaparib);
  • to identify ALK rearrangements in patients with non-small cell lung cancer who are eligible for treatment with Alecensa (alectinib); and
  • to identify PIK3CA gene mutations in patients with breast cancer who are eligible for treatment with Piqray (alpelisib).

FoundationOne Liquid CDx offers oncologists an important and minimally invasive tool to consider when making treatment decisions for their patients regardless of the type of cancer they have,” Alexander said in another company-issued press release. “These three additional companion diagnostic claims expand the test’s clinical utility into breast and ovarian cancer.”

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