The US Food and Drug Administration (FDA) is looking for up to nine drugmakers to join a pilot program intended to improve transparency for oncology drugs that rely on in vitro diagnostics to identify patients who may benefit from a particular treatment. Use of so-called companion diagnostics has increased with the proliferation of targeted therapies in recent years, especially in the oncology space.
Alongside its announcement of the pilot program on Monday, FDA released a final guidance detailing the program, which aims to establish minimum performance characteristics for tests meant to be used for patient treatment decisions.
Oncology drugs are often approved alongside an in vitro companion diagnostic, though the agency in some cases will approve a drug before a corresponding companion diagnostic is authorized, which creates a gap that is often filled by laboratory developed tests (LDTs)…
