FDA Watch: New VALID Act Would Establish Risk-Based System for LDTs Regulation

After months of dormancy, Congress has resumed its efforts to clean up the mess over regulation of laboratory-developed tests (LDTs). As part of the FDA user-fee bill that’s working its way through the Senate, members of the Senate Committee on Health, Education, Labor and Pensions (HELP) have proposed a modified version of legislation that would allow the FDA to continue to regulate LDTs on a risk-tiered basis.

The New VALID Act

The Senate bill is a revised version of the Verifying Accurate Leading-edge IVCT Development (VALID) Act, that’s been around in several different incarnations for a number of years, most recently in 2020. VALID would treat LDTs the same as tests developed by commercial companies with all in vitro clinical tests to be grouped into three tiers:

• High-Risk tests, i.e., those whose inaccurate results would be likely to cause death, serious harm or other negative outcomes, would be subject to FDA premarket review;
• Moderate-Risk tests whose inaccurate results would cause only non-life threatening or medically reversible injury or treatment delay, could be brought to market via a voluntary “technology certification” program requiring companies to demonstrate merely that they have appropriate internal test validation processes; and
• Low-Risk tests would be exempt from premarket review.

Labs and test makers would also be allowed to make changes to moderate-risk tests that reach the market without undergoing premarket FDA review, unless those changes have a potentially significant impact on the product’s safety and effectiveness.

The VALID Act Controversy

While all acknowledge the need for reforming LDT regulation, the new VALID Act has received mixed reviews. The first controversy is in regard to tactics, namely, attempting to use the FDA user-fees bill to push through systematic changes to lab test regulation, an issue that has been subject to longstanding debate across industry, Congress, the FDA, and other stakeholders. “The VALID Act remains a complex bill that will have far reaching implications for clinical microbiology laboratories and infectious disease diagnostic testing,” stated the American Society for Microbiology (ASM), while urging lawmakers “to address these concerns before advancing the bill as part of [the user-fees bill], which is a fast-moving legislative package.”

But the really divisive aspect of the new VALID is its regulatory leniency. The American Clinical Laboratory Association (ACLA), which has advocated for a risk-based regulatory framework, has embraced the bill, characterizing it as a “pivotal moment in the multiyear effort on diagnostic regulatory reform.”

But others expressed concern about the implications of allowing labs and test makers to have such easy access to the market. The bill’s exemptions “need to be narrowed to ensure that high-risk tests are subject to the appropriate oversight,” wrote the Pew Charitable Trusts. The nonprofit called for giving the FDA discretion to evaluate tests when it deems it necessary.

Others have criticized the bill for its provisions imposing user-fees for IVCT review and the financial burdens it would cause to labs. There are “vast differences between large commercial test developers and individual, nonprofit laboratories at academic and other medical centers that develop LDTs,” wrote the ASM. “Clinical microbiology laboratories already operate on a thin margin within the health care facilities and are not profit centers.” Lumping them together with big commercial entities for user-fees purposes is “unreasonable,” it added.

And, of course, there’s also the issue of whether the FDA should be in the business of regulating LDTs at all. Many believe that the agency’s assertion of control over LDTs exceeds its legal authority under the Food, Drugs and Cosmetics Act. Thus, rival legislation called the Verified Innovative Testing in American Laboratories (VITAL) Act of 2021 would strip the FDA of any oversight of LDTs and give HHS sole jurisdiction to regulate such tests under the Clinical Laboratory Improvements Act (CLIA).

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This article originally appeared in G2 Intelligence, Laboratory Industry Report, June 2022.