Comments on Oversight Framework for Molecular Diagnostic Tests, including Laboratory Developed Tests (LDTs)/House Version

Various organizations representing patients, scientists, advocates, caregivers and health care professionals, including the Alliance, sent this letter to House Speaker Rep. Paul Ryan and House Minority Speaker Rep. Nancy Pelosi that urges them to “make updating the oversight framework for all molecular diagnostic tests, including laboratory developed tests (LDTs), a priority early in the 115th Congress.” The letter continues, “We also believe strongly that FDA should play a critical role in a modernized framework that supports patient safety and access to valid tests.”

 

Lab Developed Test Guidance