Over the past few years the next-generation sequencing (NGS) company Foundation Medicine Inc. has achieved some major regulatory successes attributed to the company's ability to develop partnerships with key players in the healthcare ecosystem. In an interview with Medtech Insight, the company's data chief discussed its philosophy, approach to partnerships and vision for the future.
In December 2017, the US Food and Drug Administration approved Foundation Medicine's solid tissue gene diagnostic test FoundationOne CDx. It was the first companion broad-panel diagnostic test approved by the agency, and one of the first tests to receive breakthrough designation. It also successfully passed the Center for Medicare and Medicaid Service's parallel review program, which means it was covered by the government insurer almost immediately after being approved
