
FoundationMedicine's Liquid CDx to Launch After FDA Approval for All Solid Tumors
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
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. 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.”
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