FDA Announces Diagnostic Testing Measures

FDA has announced it is taking steps to ensure that certain diagnostic tests are accurate, consistent and reliable.

The Agency is first issuing a final guidance on the development, review and approval or clearance of companion diagnostics, which are commonly used to detect certain types of gene-based cancers.

Second, it will publish a risk-based oversight framework for laboratory developed tests (LDTs) designed, manufactured and used within a single laboratory. They include some genetic tests and tests that are used by healthcare professionals to guide medical treatment for their patients. The FDA already oversees direct-to-consumer tests regardless of whether they are LDTs or traditional diagnostics.

The companion diagnostics guidance is intended to help companies identify the need for these tests during the earliest stages of drug development and to plan for the development of a drug and a companion test at the same time. The goal of the final guidance is “to stimulate early collaborations that will result in faster access to promising new treatments for patients living with serious and life-threatening diseases”.