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FDA in Drafting Phase for LDT Oversight

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration is currently drafting its plans for regulating laboratory-developed tests and is considering available options, such as using a risk-based approach for oversight and a registry of tests to know what services are available, an FDA official told the Secretary's Advisory Committee for Genetics, Health, and Society today.

While no specific plans have yet been drawn up for regulating LDTs, the agency has completed a public comment phase, and it is now "putting together a framework document for oversight," drafting an operational plan, and "trying to decide what our options are," Elizabeth Mansfield, director of the personalized medicine staff at FDA's Office of In Vitro Diagnostic Device Evaluation and Safety in the Center for Devices and Radiological Health (CDRH), told the committee today.

FDA made clear in a public meeting in July that it plans to have CDRH begin regulating certain LDTs that currently are not regulated, because the new uses for these tests, as well as their complexity and their marketing, have increased their risks and now warrant oversight.

In decades past, labs that develop and offer LDTs have been overseen by the Centers for Medicare & Medicaid Services, but that oversight has not covered the clinical validity of these offerings, often referred to as 'homebrew' tests.

Today, Mansfield told SACGHS that the "enforcement discretion that we initially applied … became a loophole."

"Business models arose that leveraged our practice of discretion to get to the market without FDA oversight," she said. "The business model is not really problematic; the lack of oversight is problematic."

At this point in the process nothing is certain and all possible plans are only "provisional," Mansfield explained, but she said she is "pretty certain that we'll do risk-based oversight because that's what we're good at."

She added, "Our plan would be to address the highest risk first."

A central point she made to the committee is that the FDA needs to know more about what types of tests are out there, what their uses are and how they are being offered.

According to Mansfield, FDA wants to "look more broadly at all LDTs" and study the field to address this issue.

"How many [LDTs] are there? We don't know. What is being tested? What is at risk? Many of the tests being offered now have new uses," she said, explaining that FDA is "considering how to classify these ahead of time."

At the public meeting in July, Mansfield said that FDA plans to start a collaboration with the National Institutes of Health to develop a test registry that would enable FDA to monitor test developers, GenomeWeb Daily News' sister publication Pharmacogenomics Reporter reported at the time.

She said that the agency "would like to avoid numerous de novo classifications," and that it might develop "public classification panels."

At some point, although Mansfield could not specify when, FDA "will publish guidance documents with general requirements and information on complying," she said.

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