Dec. 1, 2017—Foundation Medicine announced Nov. 30 that the FDA approved FoundationOne CDx for solid tumors. The test is intended for use by health care professionals to help inform cancer treatment management in accordance with professional guidelines for patients with solid tumors and is the first FDA-approved test of its kind for all solid tumors.
FoundationOne CDx is a next-generation-sequencing–based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability and tumor mutational burden using DNA isolated from formalin-fixed, paraffin embedded tumor tissue specimens. It is also indicated as a companion diagnostic for patients with certain types of non-small cell lung cancer, melanoma, colorectal cancer, ovarian cancer, or breast cancer to identify those patients who may benefit from treatment with one of 17 on-label targeted therapies, including 12 therapies currently approved as first-line therapy for their respective indications.
Concurrent with FDA approval, the Centers for Medicare and Medicaid Services issued a preliminary national coverage determination for FoundationOne CDx. The draft NCD would provide coverage for FDA-approved companion diagnostic claims, as well as a pathway for additional coverage with evidence development in other solid tumor types. The final policy is expected to issue during the first quarter of 2018 following public comment of the preliminary NCD and an administrative period.
“Today’s historic parallel review decision from the FDA and CMS represents a major advancement in personalized cancer care,” Troy Cox, CEO at Foundation Medicine, said in a statement. “Physicians will have an FDA-approved test for all solid tumors in their toolkit that can inform targeted and immunotherapy selection, as well as identify patient opportunities for clinical trial participation. Beyond its implications for patient care, we expect that FoundationOne CDx will provide biopharma companies with an FDA-approved platform that can help accelerate drug development and enable personalized oncology care.”