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Outside the Lab Regulation and standards, Quality assurance and quality control, Laboratory management, Technology and innovation, Clinical care

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.

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  1. U.S. Food & Drug Administration, “The public health evidence for FDA oversight of laboratory developed tests: 20 case studies”, (2015). Available at: Accessed December 7, 2016.
  2. U.S. Food & Drug Administration, “FDA’s Laboratory Developed Tests Framework”, (2014). Available at: Accessed December 6, 2016.
  3. U.S. House of Representatives Document Repository, “[Discussion Draft] 114th Congress 1st Session”, (2015). Available at: Accessed December 6, 2016.
About the Author
William Aryitey

My fascination with science, gaming, and writing led to my studying biology at university, while simultaneously working as an online games journalist. After university, I travelled across Europe, working on a novel and developing a game, before finding my way to Texere. As Associate Editor, I’m evolving my loves of science and writing, while continuing to pursue my passion for gaming and creative writing in a personal capacity.

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