Highlights

• Laboratory developed tests play a critical role in medical innovation, but there is a long-standing debate over their regulatory oversight.
• Two competing bills are trying to address the issue: VITAL would maintain the status quo and VALID would transfer oversight to the FDA.
• The debate hasn’t been settled yet, and according to LDT expert Kurtis Davies “the FDA will always be trying to grab this power.”

Arguments over LDT Regulation – VITAL vs VALID

Laboratory developed tests (LDTs) are critical to medical innovation and an integral part of routine clinical care. Take, for example, the recent pandemic: COVID-19 tests are LDTs that the Food and Drug Administration (FDA) approved for emergency use. These tests played a critical role in providing rapid diagnosis and helping to control the spread of disease. This recent event has reignited a long-standing debate about which governing body should have control over LDT regulation. Is it the FDA, or should the Centers for Medicare and Medicaid Services (CMS) have control through Clinical Laboratory Improvement Amendments (CLIA)?

Historically, the FDA has authority to regulate new medical devices through the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetics Act. On the other hand, CLIA gives the Department of Health and Human Services the authority to oversee labs, including those that develop LDTs. The Department delegated this responsibility to CMS. The FDA has been pushing for control of LDT regulation as part of the Medical Device Amendments. In a 2014 draft guidance, the FDA noted that the Medical Device Amendments added authority to regulate in vitro diagnostics devices (IVDs) and, as stated in the guidance, LDTs can be defined as an IVD. The FDA also argues that CLIA is not sufficient to regulate LDTs; CLIA confirms that a laboratory can perform tests reliably and accurately, but does not evaluate a test’s clinical validity, safety, or efficacy. This regulatory debate has come to a head with two competing acts presented to Congress.

The Verifying Accurate Leading-edge IVCT Development (VALID) Act was introduced in 2021 in the House of Representatives. VALID would give the FDA sole authority over a newly-defined category of in vitro clinical tests (IVCTs) that encompasses both IVDs and LDTs. The Act proposes a two-tier regulatory system to separate high-risk tests from low-risk tests or those under emergency use authorization. Additionally, test modification would need subsequent approval. VALID would also establish a side effects reporting system. Despite the increase in regulatory oversight, VALID does encourage innovation with a “breakthrough” category designed to incentivize and expedite tests for unmet needs.

The competing Verified Innovative Testing in American Laboratories (VITAL) Act was introduced in the Senate in 2021. A much smaller bill, VITAL supports LDT regulation remaining under CMS’ CLIA including during a public health emergency like the COVID-19 pandemic.

“VITAL would maintain status quo,” said Kurtis Davies, Ph.D. Davies is an Assistant Professor and Lead Assay Development Scientist in the Department of Pathology at University of Colorado, Anschutz medical campus. VALID had strong input from the FDA as well as from industry. But, according to Davies, “VALID would essentially create a monopoly – the small biotech companies and academic centers developing cutting-edge LDTs wouldn’t be able to afford to go through the new, intensive regulatory process.” Industry giants would financially benefit from VALID passing into law. Also, more regulation isn’t always a good thing. “Just because an assay or test has been FDA-approved doesn’t make it ‘better’ than an LDT that has not been FDA-approved,” Davies explained. Even current FDA-approved tests have limitations and increased regulation could slow innovation and prevent LDTs coming to market quickly.

The community is waiting with bated breath to see when the VITAL vs VALID debate will be settled. While neither bill has passed yet, “it will always be looming over our heads,” said Davies. “The FDA will always be trying to grab this power.”

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References

1. Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs). (2014). https://www.fda.gov/media/89841/download
2. Verifying Accurate Leading-edge IVCT Development Act, H.R. 4128, 117^th (2021). https://www.congress.gov/bill/117th-congress/house-bill/4128
3. Verified Innovative Testing in American Laboratories Act, S. 1666, 117^th (2021). https://www.congress.gov/bill/117th-congress/senate-bill/1666