FDA Announces Guidance Regulating Laboratory Developed Tests

The FDA today announced their plans to “publish a proposed risk-based oversight framework for laboratory developed tests (LDTs), which are designed, manufactured and used within a single laboratory. They include some genetic tests and tests that are used by health care professionals to guide medical treatment for their patients.” The guidance would include a regulatory framework for “pre-market review for higher-risk LDTs, such as those that have the same intended use as FDA-approved or cleared companion diagnostics currently on the market.”

Foundation Medicine (FMI) welcomes the adoption of rigorous standards for LDTs, where life-altering treatment decisions can be made based on the results of these tests. We are reviewing the guidance and look forward to participating in the discussion about the guidance with the FDA and other stakeholders. FMI developed FoundationOne® on the basis that tests for patients with advanced cancer should be fully comprehensive, thoroughly validated and backed by peer-reviewed publications. The stakes are extremely high for this patient population, and testing options must meet high quality standards. We will continue our work with the FDA and ensure our approach meets its standards of excellence in this field.