FDA LDT Guidance Delayed

Laboratory developed tests (LDTs) in the US have long been under the jurisdiction of the Clinical Laboratory Improvement Law – which covers laboratory regulations in general. From vitamin assays to tests for genetic mutations, as long as the in vitro LDTs were designed, manufactured, and used within a single laboratory, there were no regulatory issues. That is, until the FDA got involved…

In recognition of the rising complexity and availability of LDTs, the US regulator now believes that tests could cause a potential health risk to patients and the public unless closely controlled. How did it reach that conclusion? As well as recognizing the criticality of tests to patient care, it closely assessed 20 LDTs and found some to display false-positives, false-negatives, or incorrect data leading to over- or under-medication (1). Its solution to this potential hazard was to release an official framework for FDA oversight of LDTs. After notifying Congress of its intentions back in 2014 (2); one year later, it submitted a 185-page discussion draft, giving a rough idea of what the regulations might be (3), and indicating that the final guidance will be released by the end of 2016. Now we’re nearing its self-imposed deadline though, there’s a delay.

“We have been working to develop a new oversight policy for LDTs, one that balances patient protection with continued access and innovation, and realizes just how important it is that we continue to work with stakeholders, our new Administration, and Congress to get our approach right,” says Deborah Kotz, FDA press officer. “The FDA believes that patients and health care providers need accurate, reliable, and clinically valid tests to make good health care decisions – inaccurate or false test results can harm individual patients.” To that end, the FDA will continue to refine the bill until it comes to what it deems “an appropriate risk-based approach” in the near future.