This summer, a “bicameral, bipartisan bill” of lofty aspirations—and lengthy debate—was appended to must-pass legislation to create a new framework for regulating lab developed tests. In case you missed it, the 245-page Verifying Accurate, Leading-edge IVCT Development (or VALID) Act quietly entered the “preconference process” in June. This detour is intended to provide an opportunity for key members of the House and Senate to create a unified bill while bypassing additional amendments and stakeholder input.
The bill’s status and potential impact on U.S. laboratories was the subject of Monday afternoon’s scientific session “VALID VITAL LDTs: Current State of Regulation Legislation of Laboratory Developed Tests.”
VALID seeks to add FDA regulation to laboratory developed—and modified—tests, commonly referred to as LDTs, in addition to current CLIA regulation. “CLIA was last updated in 1988, and many of the standard-of-care technologies used in the clinical laboratory today were not even invented the last time CLIA was updated,” noted Dr. Eric Konnick.
Konnick, who moderated the session, has more than 20 years’ experience in the industry, first as an R&D Scientist at ARUP Laboratories and now as a molecular pathologist at the University of Washington.
Konnick was quick to add that while “regulations and regulatory policy can enable and promote quality and safety if designed in a thoughtful and rational way, it can also create unnecessary and wasteful work if constructed without a clear understanding of the laboratory environment.”
Indeed, the concerns voiced by the speakers, which also included Dr. Karen Kaul, Dr. David Flannery, Dr. Dennis Dietzen, and Dr. Jonathan Genzen, echoed comments submitted to the Senate Committee on Health, Education, Labor and Pensions (HELP) by AACC and the Association for Molecular Pathology.
These and other groups have noted that the legislation has failed to resolve issues in key areas, including: duplication with and lack of modernization of CLIA; a deficiency in clarity of terms and eligibility criteria for test classification and mitigating measures; unpredictable regulatory processes subject to the discretion of the Secretary of the Department of Health and Human Services; absence of subject matter experts in the accreditation process; lack of FDA resources in meeting these obligations; preemption of state requirements; and the passing of a provision that would set the stage for a repeat performance of the emergency use authorization crisis surrounding SARS-CoV-2 testing.
Other important critiques of the bill featured prominently during Monday’s session were its impediments to innovation and constriction of patient access to care. “Many of the advances in laboratory medicine that we currently use on a daily basis were pioneered in academic and hospital laboratories as LDTs,” Konnick noted. “[Some of these] were taken up and commercialized, but many, many more tests were not because there was a clinical need but not a profitable market.”
Fortunately, the discussion was interspersed by moments of levity, and even better, a renewed sense of a path forward. In addition to helping attendees prepare for the possibility of a new regulatory regime, speakers encouraged laboratorians to continue to provide constructive suggestions to legislators and regulators to benefit patients.
“It’s important to try and find ways to build relationships and to keep a meaningful dialogue going between our professional societies as well as with our potential regulators and elected officials,” said Kaul.
To that end, attendees were invited to engage with their local representatives, to support the organizations advocating on their behalf, and to visit AACC kiosks around the convention center to submit their concerns regarding VALID to the legislators driving this drastic alteration to the LDT landscape. Just look for the sign that says, “Add your voice to ours.”