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

Various organizations representing patients, scientists, advocates, caregivers and health care professionals, including the Alliance, sent this letter to Senate Majority Leader Sen. Mitch McConnell and Senate Minority Leader Sen. Charles Schumer 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