Skip to main content
Premium Trial:

Request an Annual Quote

Foundation Medicine, Natera Launch ctDNA Therapy Response Assay With Medicare Coverage

NEW YORK – Foundation Medicine and Natera announced on Tuesday the clinical launch and Medicare coverage of the jointly developed FoundationOne Tracker personalized circulating tumor DNA (ctDNA) monitoring assay.

The tissue-informed ctDNA monitoring test is now available to healthcare providers within the US.

Medicare contractor Palmetto GBA, through its MolDx test assessment program, agreed to cover the test for the monitoring of response to immune-checkpoint inhibitor therapy for qualifying Medicare beneficiaries with all solid tumors. The assay has also been approved for coverage through New York state's Clinical Laboratory Evaluation Program of New York.

FoundationOne Tracker uses genomic information from the FoundationOne CDx comprehensive genomic profiling test. The two companies had launched an early-access program for the assay in the beginning of the year.

Physicians may use the assay to monitor their patients' response to therapy, thereby identifying treatment-resistant patients who may benefit from alternate therapies, as well as patients who respond well to therapy and who might benefit from dose reduction or therapy discontinuation.

"Tissue-informed ctDNA monitoring is a natural extension of Foundation Medicine's current genomic testing portfolio, and we believe this new offering will further enable oncologists to make the best possible decisions about their patients' care through actionable and personalized data," Foundation Medicine CEO Brian Alexander said in a statement.