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LDT Regs Coming

The US Food and Drug Administration plans to implement a risk-based regulation of laboratory-developed tests over the course of the next decade, GenomeWeb Daily News reports.

"Just as drugs need to be safe and effective for treating diseases, medical devices used to help diagnose disease and direct therapy also need to be safe and effective," Margaret Hamburg, the FDA commissioner, said at a news conference yesterday, according to the New York Times. Inaccurate results, she added, "could lead patients to seek unnecessary treatment or to delay or to forgo treatment altogether."

The agency plans to release its draft guidance in 60 days, and yesterday's announcement of its intent fulfills a requirement of the Food and Drug Administration Safety and Innovation Act to inform Congress of its intent to release the draft.

According to GWDN, moderate-to-high risk lab tests will be subject to premarket review as well as registration, listing, and adverse event reporting requirements. The agency will first focus on high-risk devices that have the same intended use as cleared or approved companion diagnostics before concentrating on LDTs with same intended use as FDA-approved Class III devices and those that determine whether blood products are safe and effective.

FDA plans to continue its "enforcement discretion" of low-risk, Class I devices and LDTs for rare diseases and unmet medical needs.

"AdvaMedDx welcomes the publication of the draft framework on a risk-based approach to the regulation of LDTs and looks forward to reviewing the draft guidance when it is issued," says Andrew Fish, executive director of AdvaMedDx, in a statement. "These types of tests are increasingly being used to diagnose and guide the treatment of potentially life-threatening conditions, and FDA oversight of higher risk diagnostic tests including companion diagnostics, regardless of the manufacturer, is essential to patient safety."

The draft guidance has been held up at the White House Office of Management and Budget for review, remaining there for a number of years. Five Democratic Senators recently wrote a letter to the office asking for its release. "Because these more advanced LDTs are a staple of clinical decision-making and are being used to diagnose, high-risk, but relatively common diseases, it is imperative that they perform as they are expected," the senators led by Massachusetts' Ed Markey said in the letter.

Others, however, argue that FDA oversight of LDTs will slow the pace of medical advances.

"The ability of laboratories to develop custom diagnostic tests has been critical to the growth of personalized medicine and keeping pace with the changing face of disease," nearly two dozen laboratory directors and pathologists said in a recent letter to the Obama administration, according to the Times. Tighter regulation, they argue, will make it more difficult to respond to situations such as SARS and influenza outbreaks as well as incorporate new knowledge about cancer into tests.

"Laboratories have been regulated for decades by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) and by state law," says Alan Mertz, the president of the American Clinical Laboratory Association, in a statement. "Under the CLIA framework, a thorough and detailed regulatory process, we've seen an explosion of innovation in laboratory diagnostics that has allowed labs to diagnose and measure disease with an accuracy and precision never before possible. This has changed how the medical world views and treats everything from rare diseases to infectious disease to cancer."

There will be a 60-day public comment period after the draft regulations are published in the Federal Register, FDA says.