Liquid CDX, a blood test, analyzes more than 300 genes and genomic signatures across all solid tumors.
The FDA this week approved another liquid biopsy test to inform precision medicine for solid tumors, the second such approval in less than a month.
FoundationOne said the approval is for Liquid CDx, a companion diagnostic for 4 FDA-approved targeted therapies, including rucaparib (Rubraca) for prostate cancer and 3 tyrosine kinase inhibitors for non–small cell lung cancer (NSCLC).
The pan-tumor liquid biopsy test, which analyzes more than 300 genes and genomic signatures, will launch Friday, August 28 and is for use on all solid tumors.
The test can also assist accelerated companion diagnostic development developing their own precision drugs, FoundationOne said in a statement. As a comprehensive genomic profiling assay, it 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.
The results give providers clinical trial information and “includes interpretive content developed in accordance with professional guidelines in oncology for patients with any solid tumor,” the company said.
“We are seeking additional companion diagnostic claims for FoundationOne Liquid CDx, which, if approved, would further enhance utility of the test in clinical practice,” Brian Alexander, MD, MPH, chief medical officer at Foundation Medicine. “Additionally, this test is an important tool for the acceleration of drug development and for understanding mechanisms of resistance.”
Earlier this month, the FDA approved Guardant360CDx to provide information on multiple solid tumor biomarkers and to help identify EGFR mutations in patients who will benefit from treatment with osimertinib (Tagrisso), which is approved for a form of metastatic NSCLC.