Myriad Genetics received FDA approval for its MyChoice Ovarian Cancer CDx, a companion diagnostic designed to guide therapy selection for ovarian cancer patients, according to GenomeWeb.
The approval comes as Myriad executes what the company has described as a broad menu refresh. At the J.P. Morgan Healthcare Conference earlier this year, Myriad outlined plans to launch five minimal residual disease tests in the coming years.
The companion diagnostics market remains competitive. Per 360Dx, FDA cleared tests from Roche, Siemens Healthineers, Beckman Coulter, and other manufacturers in February. In the ovarian cancer CDx space, Myriad faces competition from Foundation Medicine's FoundationOne CDx and other broad tumor profiling platforms.
Companion diagnostic designations create revenue streams tied to pharmaceutical partners' drug sales. Each new drug indication that references a specific CDx in its FDA label creates demand for that diagnostic. For Myriad, which has faced revenue pressure from competition in hereditary cancer testing, the CDx business represents a partner-dependent revenue line less exposed to direct-to-consumer pricing dynamics.