WASHINGTON – During a panel discussion at the Next Generation Dx Summit this week in Washington, D.C., stakeholders from the lab and diagnostics world tackled questions around the Verifying Accurate Leading-edge IVCT Development (VALID) Act and how it could affect those industries.
The bill, which would formally give the US Food and Drug Administration authority over laboratory-developed tests, remains contentious, with the panelists split on whether it would bring needed oversight to LDTs or add unnecessary red tape that could compromise patient care.
The panel featured Jeff Allen, president and CEO of Friends of Cancer Research; Sarah Thibault-Sennett, director of public policy and advocacy at the Association for Molecular Pathology; Lauren Silvis, senior VP of external affairs at Tempus; Susan Van Meter, president of the American Clinical Laboratory Association; and Zach Rothstein, executive director at AdvaMedDx and senior VP of technology and regulatory affairs at AdvaMed.
There was, by and large, consensus among the panelists that a change in the current LDT regulatory landscape is needed — both to provide the industry with clear and predictable guidelines and to ensure test quality and consistency — but there was less agreement on what path those changes should take.
AdvaMed, which represents in vitro diagnostics manufacturers, has been a vocal proponent of the bill, arguing that both IVDs and LDTs should be under a single, consistent regulatory regime, and Rothstein reiterated this view, noting that the organization believes that all of these tests "should come under FDA review."
Allen, of Friends of Cancer Research, likewise spoke favorably of the bill, noting the increasing complexity of cancer care and the tests used to diagnose different cancers, and suggested VALID was needed to establish consistency and assure quality across the industry.
Taking the opposite position was AMP's Thibault-Sennett, who argued that the stated goals of VALID's advocates could be better achieved by modernizing CLIA.
Tempus' Silvis and ACLA's Van Meter were both more circumspect, noting that the bill could provide the industry with regulatory certainty while also raising some areas of concern.
The VALID Act aims to resolve decadeslong questions around the FDA's authority to regulate laboratory-developed tests by placing them within the agency's purview. The proposed legislation would create a risk-based framework for in vitro clinical test (IVCT) regulation, with high-risk tests, such as novel assays, required to go through premarket review, while lower-risk tests could go to market after passing through technological certification. VALID would grandfather in LDTs currently in clinical use.
A key factor driving the push for FDA oversight of LDTs is the boom in recent years in LDTs using highly complex technologies like next-generation sequencing and addressing high-stakes areas like cancer diagnosis and treatment.
In making the case for VALID, Allen highlighted such tests, noting that Friends of Cancer Research has found a lack of consistency across labs.
"These are very complicated tests that are executed and developed by highly qualified experts and individuals," he said. "But with that consistency of performance standards, what we've seen is that there can be variations between different tests that are being used for the same intended use."
He added that consistent rules around reporting of performance details are needed to address this issue.
Thibault-Sennett agreed with Allen's general point about the need for greater consistency but argued that in the case of LDTs this could be better handled by updated existing CLIA regulations. In 2015, AMP released a proposal for modernizing CLIA to better oversee LDTs. Thibault-Sennett noted that the proposal included processes like interlaboratory comparisons to ensure test performance and consistency across labs.
An important question for several of the panelists was whether the FDA and the lab industry will have the money and personnel to meet VALID's requirements if the bill ultimately passes. VALID will likely increase costs for labs as they will need to hire new staff and institute new procedures to comply with the law. Those increasing costs would come at a time when both private and government insurers are squeezing lab reimbursements.
Noting this, ACLA's Van Meter highlighted the recently introduced Saving Access to Laboratory Services Act, or SALSA, as a key priority for the lab industry. The bill would institute a statistical sampling-based approach to collecting lab test pricing data that proponents believe would both alleviate the administrative burden on labs and ensure that price data is collected from a more representative slice of the industry. It would also stop price cuts scheduled under current law to go into effect at the start of 2023, extend the time between price reporting periods from three years to four, and place caps of 5 percent on both the annual cuts and increases a given test could see under PAMA.
Thibault-Sennett also warned of "the incredible financial burden laboratories would be under if VALID were to pass," and added that "small laboratories" have not been sufficiently considered in conversations around VALID. She also suggested that the law's potential impact on labs at academic medical centers could threaten lab training programs at these centers, which, she said, could further exacerbate the industry's staffing shortages.
Panelists also raised concerns about whether the FDA will have sufficient resources to oversee LDTs.
Tempus' Silvis cited the FDA's struggle to quickly review both COVID-19 and non-COVID-19 tests during the pandemic as an example of "how important it is for any review program to be well resourced."
The COVID-19 pandemic provided "a very clear case study in how the FDA didn't have the bandwidth to handle the just-over-2,000 [Emergency Use Authorization applications] that were submitted," Thibault-Sennett said, adding that if VALID were to pass, "hundreds of thousands of LDTs would newly fall under FDA's jurisdiction."
She said that AMP has "very large concerns" about the agency's ability to handle these new responsibilities, noting that even if the agency receives the necessary funding, "we are honestly not sure they can find the number of people they need to find and review all of these in a timely manner."
Allen, however, argued that while more resources for the FDA will be necessary, he didn't think this was a reason not to pursue VALID.
"I think we have to be driven by the science here … and make sure then that [regulation] can be implemented as appropriate," he said, noting that this could mean providing the FDA additional money beyond what it collects in user fees or ensuring labs and test developers are provided with clear guidance regarding the regulatory pathways and requirements for their products.
Van Meter noted that in its discussions with legislators, ACLA has been focused on establishing a "more robust third-party review program" that would allow developers to take their tests through review bodies outside the FDA like New York's Wadsworth Center, thereby augmenting the FDA's resources.
Rothstein noted that the new Medical Device User Fee Amendments bill (MDUFA V) calls for a substantial increase in FDA staff. He added that, if it passes, VALID would go into effect in five years, which is also when the next MDUFA renewal will come up, meaning Congress will have the opportunity at that time to provide the FDA with additional resources if it becomes apparent that they are needed.
Whether VALID will, in fact, become law, remains an open question. The bill made it out of the Senate Health, Education, Labor, and Pensions (HELP) Committee in June, but one of its main supporters, Sen. Richard Burr, R-N.C., voted against it in committee, and the bill was not included in the House Food and Drug Amendments of 2022 bill (which reauthorizes the FDA user fee program).
"I couldn't put odds on [its passage]," Van Meter said during the panel.
Rothstein said he believed the bill could potentially be attached to another piece of legislation if it fails to pass as part of the Medical Device User Fee Amendments, though he said it was unclear at the moment what that legislation might be.
"A lot of it depends on what happens with the midterm elections," he said. "Today it's really hard to predict. I think if you ask in November, it might be a little easier."
Silvis noted that if the bill doesn't pass, the FDA's concerns around LDT oversight will remain.
She added that, regardless, she hopes to see some of the ideas in VALID applied to diagnostics regulation going forward.
She said that early iterations of VALID adopted "a more traditional medical device framework," but that over time Congress and the FDA have responded to industry feedback by adopting "an approach that has shown more modernization, both for laboratory tests and for IVDs … that may make their review more efficient."
Van Meter agreed that VALID has over time "really changed to become much more truly a diagnostic focused effort." She highlighted as an example, the bill's provision for a "technology certification" pathway, which would allow test developers to launch low-risk tests on certain certified technology platforms without going through premarket review. While it remains unclear how exactly this provision will be interpreted and implemented, Van Meter suggested it could allow test developers to more easily iterate on tests that fit within the scope of such a certification.
This notion that VALID would modernize test regulations by tailoring them to diagnostics as opposed to traditional medical devices gets to a key aspect of the IVD industry's support for the bill. While it would place new burdens on LDT test development, it includes provisions, like the technical certification pathway, that could provide new flexibility for IVD manufacturers.
Point of Care
One topic that didn't come up during the panel and has been little discussed generally is the provision in the Senate draft of the bill that allows for the exemption of certain point-of-care tests from premarket review.
Under current regulations, point-of-care tests cannot be designated 510(k) exempt, meaning they can't be marketed without FDA clearance, even in cases where the lab-based equivalent of that point-of-care test is 510(k) exempt.
As currently written, VALID would change that. According to the law, no later than one year after its enactment, the secretary of the Department of Health and Human Services must issue a draft guidance laying out categories of point-of-care tests that will be exempted from premarket review, essentially loosening regulation of the point-of-care industry even as it tightens up oversight of LDTs.