Laboratory developed tests increasingly used to help diagnose conditions such as Lyme disease and cancer, and determine treatments


Washington (July 2, 2014) – Senator Edward J. Markey (D-Mass.) was joined today by Senators Richard Blumenthal (D-Conn.), Elizabeth Warren (D-Mass.), Sherrod Brown (D-Ohio), and Dick Durbin (D-Ill.) in calling on the Obama administration to release draft guidance to ensure appropriate oversight of laboratory developed diagnostic tests (LDTs), which are used to help diagnose specific forms of cancer and other diseases and are not approved by the Food and Drug Administration (FDA). Laboratories initially manufactured LDTs that could be used for low-risk diagnostics or for rare diseases, but with new technology, they have become a staple of clinical decision-making and are being used to diagnose high-risk but relatively common diseases such as ovarian cancer. Recently, the Centers for Disease Control and Prevention (CDC) reviewed a frequently utilized LDT to detect Lyme disease and found “serious concerns” about false-positive results and misdiagnosis. The CDC recommended that the diagnosis of Lyme disease should instead be left to tests approved by the FDA. In 2008, a company that sold a diagnostic test used for ovarian cancer pulled the product from the market after receiving complaints that women who did not have cancer were undergoing surgery to remove ovaries as a result of incorrect test results. Several years ago, the FDA submitted draft guidance to ensure oversight of these diagnostic tools. However, the Office of Management and Budget (OMB) has yet to act and release the draft guidance, causing confusion for doctors, patients and the marketplace.


“For years this draft guidance has languished at OMB causing continued unpredictability and uncertainty for industry, clinicians, patients and the general public,” write the lawmakers in the letter to OMB. “These tests and their results are increasingly relied on by patients and medical professionals to help predict the most appropriate course of treatment and care. These tests hold great promise to customize healthcare to be more efficient and targeted for an individual patient.” 


A copy of the letter to OMB can be found HERE.