The VALID Act appeared to win hearts over the hammer of a forthcoming U.S. Food and Drug Administration (FDA) final rule expected to drop heavy regulations on clinical laboratory developed tests (LDTs), a hearing of the House Subcommittee on Health revealed Thursday.
Medical technology trade organization AdvaMedDx and other clinical lab stakeholders appeared before members of Congress. For years now, they’ve been embattled over two key decisions facing U.S. lawmakers and federal regulators. One is passing the Verifying Accurate Leading-Edge In Vitro Clinical Test Development (VALID) Act. The other is issuing the final rule granting the FDA greater power to regulate LDTs as medical devices.
Legislators expressed near-frustration that the issue of LDT oversight has not been resolved, saying that the FDA’s hand was forced due to inaction of lawmakers. AdvaMedDx Executive Director Zach Rothstein and others spoke out for, against, and somewhere in the middle of supporting the VALID Act versus FDA rulemaking.
LDTs in market unknown
As the debate over LDT oversight has persisted through the years, an unknown number of LDTs have come to market and are actively used in clinical practice. Many LDTs pose no problems, but some — especially those with a major impact on medical treatment decisions and patient safety — may be debatable depending who you ask.
AdvaMedDx’s Rothstein urged passing diagnostic regulatory reform. Rothstein’s organization is a division of the Advanced Medical Technology Association (AdvaMed), a trade organization that represents industries, including manufacturers of in vitro diagnostic (IVD) tests.
“As a nation, we would all be better off in a system that really puts test makers in a place where they are competing based on quality and innovation not gaming out a bifurcated regulatory program,” Rothstein told lawmakers and peers.
Noted of VALID Act
Rothstein explained that the VALID Act includes provisions that encourage regulatory certainty as well as the development of “cutting-edge novel diagnostics.” During testimony, he emphasized the role of technology certification and usefulness of a clarified mechanism for all tests to follow. Both are provided in the VALID Act, he said.
“… we have supported, and continue to support, comprehensive legislative reform that would result in a modernized regulatory framework that spurs innovation and access to testing and is applied to all diagnostic tests based on their level of risk.”
Some LDTs confusing
Among the key points made during the hearing is that no one knows how many LDTs are currently being used in the market.
Jeff Allen, PhD, president and CEO of Friends of Cancer Research, pointed out the magnitude of decisions being made based on the results of some types of LDTs, as well as the risks associated with inaccurate results and difficulty of test interpretation. The environment is increasingly complicated, he said.
“There are multiple different tests that have a similar intended use,” Allen said. “There needs to be a more transparent system to be able to understand how different tests relate to one another. … Under the current paradigm, there’s no way of knowing the number of tests that are being offered, let alone how they are performing, and I think that that is issue number one that would be achieved by additional oversight here, by bringing all tests into a common construct, a level playing field, and understand what is being done in the environment and giving FDA the ability to act if warning signs are seen so that they can work with the developer, mitigate those challenges, and make sure they’re resolved.”
Dear Congress: help the FDA
Rothstein suggested that Congress help the FDA increase its review capacity of LDTs. He also encouraged the proposed user fee program, saying it is essential for bringing both the industry and the FDA together to ensure that both product makers and regulators have clear rules in terms of what an FDA review timeline would look like and that the FDA meets timelines.
Another key point Rothstein made is that currently, LDTs that are not subject to FDA regulations don’t include a public repository of the data associated with how they operate.
“CMS has actually testified to this issue before, before this committee in the sense that not only can LDTs have variability in their results but also that there’s no public mechanism to understand what that variability looks like,” Rothstein continued. “So we think it’s important that any comprehensive regulatory reform in this space include that public repository so that both patients and providers have access to that information …”
Other points made
AdvaMedDx further recommends that LDT oversight framework include “a premarket review standard that is clearly defined for diagnostics as analytical and clinical validity,” and a risk-based approach exempting low-risk, well-established tests from premarket review.
The hearing also featured testimony from Drs. Dara Aisner, a professor of pathology and medical director of the Colorado Molecular Correlates Laboratory at the University of Colorado, representing the Academic Coalition for Effective Laboratory Developed Tests; Donald Karcher, president of the College of American Pathologists (CAP); and Susan Van Meter, president of the American Clinical Laboratory Association (ACLA). Watch the full hearing via YouTube.
