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US Senators Urge Obama Administration to Release FDA Draft Guidance on LDTs

NEW YORK (GenomeWeb) – US Senators are urging the Obama Administration to release draft guidance from the US Food and Drug Administration covering the regulation of laboratory-developed tests.

Last week in a letter to Brian Deese, the acting director of the Office of Management and Budget, five Senate Democrats called for "prompt action in releasing draft guidelines" on LDTs "to ensure appropriate and efficient oversight of diagnostic tools can move forward in an open and transparent manner."

Signed by Sens. Richard Blumenthal of Connecticut, Sherrod Brown of Ohio, Richard Durbin of Illinois, Edward Markey of Massachusetts, and Elizabeth Warren of Massachusetts, the letter is the latest development in a long-brewing issue over the regulation of LDTs.

Such tests were initially developed by laboratories for use in limited numbers of patients being treated at the same facility where the test is developed and have traditionally been regulated under Centers for Medicare and Medicaid Services' Clinical Laboratory Improvement Amendments. But with the propagation of LDTs and their deepening complexity, the FDA has taken steps to oversee their development and uses.

In 2011, the FDA released a draft guidance recommending agency approval of LDTs that are used to determine whether a patient should receive a drug, and last year FDA Commissioner Margaret Hamburg suggested to an audience at the American Society of Clinical Oncology's annual meeting that the agency could once again move to regulate LDTs, according to Pharmacogenomics Reporter.

LDT makers argue that increased regulation of tests would impede innovation, create an unlevel playing field, and drive up costs.

In their letter, the senators outlined the evolution of LDTs from "relatively simple, well-understood pathology tests … for low-risk diagnostics or for rare diseases for which adequate validation would not be feasible," to tools that are now being widely used by medical professionals. As the understanding of genetics and its role in diseases has grown, physicians and other clinicians are increasingly using LDTs for diagnostic purposes and to determine the most appropriate course of treatment and care, the senators said. It follows then that steps need to be taken to ensure that such tests work properly, they added.

The lawmakers noted that the Centers for Disease Control and Prevention recently reviewed a "frequently utilized LDT" for Lyme disease and found "'serious concerns'" about the test's false-positive results and misdiagnosis. The CDC determined that diagnosis for Lyme disease should be made using FDA-approved tests.

The FDA's draft guidance on LDT regulation, the senators said, "has languished" at the Office of Management and Budget for years, "causing continued unpredictability and uncertainty for industry, clinicians, patients, and the general public." By releasing the draft guidance, the public will be able to comment on it, and then FDA can finalize its guidelines. As it is, that process could take "an additional significant amount of time," necessitating a prompt release of FDA's draft guidance, they said.

Their letter follows a similar note sent by members of the House of Representatives almost a year ago to OMB also urging the release of FDA's draft guidance.