Roche and Foundation Medicine have launched a new blood test in the U.S. that analyzes 70 genes known to drive solid tumor growth, as well as microsatellite instability high status, to help guide the use of precision cancer treatments and immunotherapies.
“With the commercial launch of FoundationOne Liquid, we are further expanding access to important genomic information that has the potential to match more patients to targeted therapies,” as well as aid clinical trial design and product development, Foundation Medicine Chief Commercial Officer Tom Civik said in a statement.
“For many cancer patients, traditional tissue testing is not feasible, and there is a pressing need for minimally invasive solutions to help inform personalized treatment decisions,” Civik added. Roche estimated that—in certain patients with advanced non-small cell lung cancer, for example—about 15% would be ineligible for tissue biopsy, while 10% would have a biopsy too small to be tested.
The FoundationOne Liquid next-generation diagnostic detects gene substitutions, rearrangements, insertions and deletions, as well as copy number alterations, from sequences of circulating cell-free DNA isolated from the bloodstream.
It expands on the company’s previous liquid biopsy test, FoundationACT, and complements the FoundationOne CDx tissue-based genomic profiling test launched in the U.S. this year.
This past summer, Roche agreed to a $2.4 billion deal to buy out the Cambridge, Massachusetts-based Foundation Medicine, following up on its $1 billion investment from three years before, which gave it a 56% stake in the company.
Roche plans to maintain an arm’s-length relationship, with Foundation continuing its companion diagnostic deals with Merck and Pfizer, while allowing Roche to further its plans in pan-cancer genomic profiling tests.
In April, the FDA granted a breakthrough device designation to Foundation’s liquid biopsy assay under development for measuring blood tumor mutational burden as a genomic biomarker. If approved, the test could be the first liquid biopsy to incorporate multiple companion diagnostics and biomarkers to guide cancer therapies, the company said.