NEW YORK – Stakeholders appear largely indifferent to an amendment meant to address concerns about a bill aimed at settling a longstanding issue for laboratory-developed tests.
Currently working its way through Congress, the Verifying Accurate Leading-edge IVCT Development (VALID) Act will — if it becomes law — formally give the US Food and Drug Administration authority over LDTs, settling an issue that has roiled the lab and diagnostics industries for decades.
Worries remain, however, about the new regulations the bill will place on test developers, with some observers suggesting they could lead to less test development and potentially impact patient care. An amendment proposed by Sen. Tommy Tuberville, R-Ala., could help address this issue, but it has sparked relatively little interest, both within Congress and among industry participants.
A major challenge to regulating LDTs is the fact that these tests span a wide variety of settings, use cases, and commercial strategies. Traditionally, many LDTs have been developed in hospital labs or at academic medical centers in response to physician requests with labs stepping in to provide assays that doctors need for patient care but for which commercial in vitro diagnostics don't exist.
In recent decades, though, the LDT route has emerged as a popular go-to-market strategy for diagnostic companies looking to commercialize their products without having to first take them through the FDA. While these firms offer their tests out of a single CLIA facility as is required of LDTs, they are typically sold nationally, allowing them to achieve distribution similar to that of an IVD. Many of these tests also use new and complex genomic and proteomic technologies, which has drawn the attention of regulators and helped drive the push for legislation like VALID.
While some argue placing these nationally distributed LDTs under FDA regulation will hamper innovation, many believe that this segment of the industry will be little affected.
"My view, and what we have heard from a lot of our clients who are working at specialty commercial labs, is that they are not as worried about VALID because they have to put so much evidence behind their tests to reach the threshold of clinician and payor adoption that it is way above and beyond what the FDA is looking for," Gary Gustavsen, a partner and managing director at consulting firm Health Advances, told 360Dx last month.
More concerning is the possibility that VALID will prevent hospital and academic labs from developing tests doctors request for patient care. While medically useful, these tests may not have a large base of users or be particularly profitable and, some observers argue, labs could cease or cut back their development in the face of new regulations.
In a June letter to the Senate Health, Education, Labor, and Pensions (HELP) committee, the American Hospital Association raised concerns that as currently written, VALID "could lead to a loss of patient access to many critical tests and could dramatically slow down advances in hospital and health system laboratory medicine."
The association suggested that Congress instead prioritize oversight of "manufacturers and commercial laboratories selling and distributing test kits" and "direct-to-consumer tests and tests used outside of the physician-patient context."
Tuberville's amendment, which he introduced during Senate HELP committee markup of the VALID Act in June, aimed to draw at least a rough distinction between these two kinds of LDTs by exempting tests developed at academic medical centers from regulation under VALID. Under the amendment, an academic medical center is defined as "an accredited medical school; an accredited academic hospital; a faculty practice plan affiliated with a hospital; or a hospital in which the majority of the physicians on the medical staff consists of physicians who are faculty members."
Introducing the bill, Tuberville said it was intended to ensure "that access to care is not threatened and innovation in our medical centers is protected."
Though it doesn't address all the objections of VALID's opponents, Tuberville's amendment would assuage some concerns about the bill's impact on patient care. It could also, however, create new loopholes and challenges for LDT regulation. Would, for instance, large academic medical centers step up development of nationally distributed LDTs? Could they potentially do so in partnership with outside diagnostic firms in ways that would let those firms evade VALID?
In any case, the amendment has generated relatively little visible interest and appears to have little momentum at present. Industry observers contacted by 360Dx said they hadn't seen it receive much attention to date. Tuberville's office declined to discuss the amendment and its potential workability beyond pointing to the text of the amendment and his statements introducing it during the June HELP committee meeting.
The Association of American Medical Colleges similarly had little to say on the matter, declining an interview request. Heather Pierce, senior director of science policy and regulatory counsel at AAMC emailed a comment that said the organization "appreciate[s] Sen. Tuberville’s amendment and recognition of the unique clinical care environment of academic medical centers and integration of LDTs developed in academic clinical labs into the delivery of patient care."
Shannon Haymond, associate professor of pathology at Northwestern University Feinberg School of Medicine and president of the American Association for Clinical Chemistry, which has been one of the most vocal opponents of VALID, noted that the organization had "previously circulated legislative language on Capitol Hill that would have exempted the 11,000 high-complexity CLIA labs" from VALID.
Haymond noted that this sort of broader amendment would be AACC's preference, but said that it supports the Tuberville amendment "as an improvement over the alternative to ensure that patients are not denied tests, particularly for rare diseases for which laboratory-developed tests are an integral part of patient care."
As might be expected, VALID's supporters have generally come out against the amendment.
Michael Dobias, officer on the Pew Charitable Trusts’ Health Care Products project, which has been a strong advocate for the bill, said the amendment "would be a departure from VALID’s risk-based approach and would recreate the kinds of loopholes that this bill is meant to end."
Sen. Richard Burr, R-N.C., and Senate HELP Chair Patty Murray, D-Wash., who have led the push for VALID in the Senate, both opposed the amendment when it was introduced, with Burr emphasizing the need for all diagnostics to be covered by a single, coherent regulatory framework and Murray saying that the language of the amendment "is far too broad and would leave large gaps in the VALID framework."
Murray tabled the amendment, meaning it was not considered during the HELP committee meeting.
Rep. Larry Bucshon, R-Ind., one of the sponsors of VALID in the House, said that he would have opposed the amendment had it come up in the House deliberations on the bill. Bucshon said that he believes "that exemptions to the requirements of the VALID Act should be based not on the affiliation of a lab, but on the particular set of circumstances under which a test is performed."
He noted that the Senate bill includes exemptions "for [tests] identifying conditions affecting fewer than 10,000 individuals and a low-volume exemption for tests that will be used only by a limited number of patients."
Indeed, the bill sets a threshold at 10,000, or higher if determined by the secretary of Health and Human Services, as long as the test is not meant for screening or for diagnosing a contagious disease with a potential public health impact.
For the custom or low-volume exemption, the bill sets a threshold of "a test system performed for not more than five patients per year (or such other higher number determined by the Secretary)," and "for which no other in vitro clinical test is commercially available in the United States."
Unlike the Tuberville amendment and as per the principle Bucshon espoused above, these exemptions are based on the characteristics of a given test as opposed to the lab performing it. The cited thresholds have proved controversial, with, for instance, Pew arguing the 10,000 individual limit is too high and AACC arguing it is too low.