Earlier this month, Senator urged Obama administration to release draft guidance to ensure appropriate oversight of laboratory critical diagnostic tests


Washington (July 31, 2014) – Senator Edward J. Markey (D-Mass.) today applauded the Food and Drug Administration (FDA) for releasing long-overdue guidance to ensure appropriate oversight of laboratory developed diagnostic tests (LDTs), which are used to help diagnose specific forms of cancer and other diseases but are not approved by the FDA. Earlier this month, Senator Markey led a letter to the Obama administration with Senators Richard Blumenthal (D-Conn.), Elizabeth Warren (D-Mass.), Sherrod Brown (D-Ohio) and Richard Durbin (D-Ill.) calling for it to release the draft guidance that has been languishing for years at the Office of Management and Budget. Laboratory developed tests are being increasingly used to help diagnose conditions such as Lyme disease and cancer and determine appropriate treatments. However, the Centers for Disease Control and Prevention recently reviewed a frequently utilized LDT to detect Lyme disease and found “serious concerns” about false-positive results and misdiagnosis.


“I am pleased that OMB and FDA have responded to my call to finally release draft guidance to provide clarity in the oversight of laboratory developed diagnostic tests. The advancement of personalized medicine will help transform our healthcare landscape. Once this guidance is finalized, doctors and patients can rest and test assured knowing that certain high-risk diagnostic tests have been subject to the additional oversight by the FDA that will help ensure that diagnoses based on these tests are sound. I look forward to the public comment period sparked by the release of this draft and quick finalization of the guidance that can provide certainty and help continue to spur the development of innovative tests for patient care.”