NEW YORK — Laboratory geneticists are concerned about the possibility of changes to how laboratory-developed tests are regulated in the US, according to survey results presented at the American College of Medical Genetics and Genomics annual meeting this week.
The organization's advocacy and governmental affairs committee found that laboratory geneticists, more so than clinical geneticists, thought that the regulation of LDTs should be a priority policy area for the organization. This comes amid increased expectations that a bill introduced to Congress, dubbed the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, may pass. That bill would have the Food and Drug Administration oversee a new class of products dubbed in vitro clinical tests (IVCT).
"After multiple discussions with individuals within the laboratory community, I can see the value of improved regulation within our laboratories," Brandon Shaw, director of the cytogenomic laboratory at Henry Ford Hospital, said during an ACMG session on public policy and legislation on Thursday. "However, the solution cannot result in a lack of innovation or put our laboratories in a position where they must choose between offering the best tests for the patients and the cost of developing these tests."
The ACMG advocacy and governmental affairs committee, established in 2020, conducted the survey to help guide its policy priorities, asking the voting members or fellows of the organization about their policy concerns.
Of the eligible members, 166 responded to the survey, 93 of whom were clinical geneticists and 73 were laboratory geneticists. Most respondents worked in academic medical centers or universities, according to Marco Leung, a clinical director at the Institute for Genomic Medicine at Nationwide Children's Hospital, who presented the results at the ACMG meeting. He noted that the survey had limitations, including a low response rate.
As part of the survey, respondents were asked to choose their top five policy issues on which they thought ACMG should focus from a list of about 20 options. These options ranged from patient access to clinical trials to telehealth coverage to reducing disparities in genetic medicine.
Across all respondents — both clinical and laboratory geneticists — the top three concerns were payor coverage of genetic services, growing the medical genetics workforce, and patient access to medical genetics services.
The two groups had differences in priorities, though. Laboratory geneticists were more concerned about the regulation of laboratory-developed tests, as about 30 percent of those respondents chose it as a policy issue to focus on, as compared to about 10 percent of clinical geneticists.
LDT regulation, Leung noted, is already a priority within ACMG, and the committee already has reviewed both the VALID Act as well as another bill called the Verified Innovative Testing in American Laboratories (VITAL) Act. Either bill would clarify a long-running debate regarding the FDA's authority to regulate LDTs. The agency has generally exercised enforcement discretion over LDTs, allowing the Centers for Medicare & Medicaid Services to oversee them through the Clinical Laboratory Improvement Amendments.
The VALID Act, which has been introduced into both the House of Representatives and the Senate, would create a new product class of IVCTs that encompasses test kits and laboratory-developed tests. It would also give the FDA both pre- and postmarket authority over IVCTs. Under a risk-based framework to oversee the regulation of IVCTs, low-risk tests would be exempt from premarket review but would have to go through technological certification, while high-risk tests would need to undergo premarket review. Existing tests could be grandfathered in.
Lawmakers have recently indicated that the act would be taken up this year and could be attached to the must-pass reauthorization bill, the Medical Device User Fee Amendments (MDUFA) program, which enables the FDA to charge companies fees for reviewing medical devices.
A number of points of the VALID Act are unclear, Shaw said. In particular, it is not yet known which manual tests might be exempt, what factors could mitigate an otherwise high-risk test, or which tests would be considered low risk. He also said that the reporting requirements — such as annual reports and of adverse events — could stress many labs and could require them to hire people with particular experience dealing with FDA reporting requirements. He also added that the costs associated with undergoing reviews could stifle innovation in the lab.
"In its current state, there are several unknowns. … I feel like due to these unknowns, the VALID Act should remain separate from MDUFA allowing for further development of criteria, definitions, and possibly portals that allow for these reporting requirements to be done more easily for the laboratories," Shaw said.
The VITAL Act, which was introduced in 2020 and again in 2021, would instead place the regulation of lab-developed tests under the authority of the US Health and Human Services Secretary. This, Shaw said, would keep oversight of LDTs under the auspices of CMS and CLIA. Leung added that the ACMG advocacy and governmental affairs committee recommended supporting the VITAL Act, which ACMG did in a 2020 letter to lawmakers.
However, Shaw noted that the VITAL Act does not have much support in either the House or the Senate.
Michelle McClure, the director of public policy for ACMG, noted during the session that the organization is trying to work with members of Congress "to find a good compromise and solution for this effort to increase FDA regulation of laboratory-developed tests."