Skip to main content
Premium Trial:

Request an Annual Quote

Congress Revives LDT Regulation Efforts, but Prospects are Cloudy


This story has been updated to note that the VALID Act was reintroduced in Congress this week.

NEW YORK – Legislators this week reintroduced the Verifying Accurate Leading-edge IVCT Development (VALID) Act, reviving the effort to reform diagnostics regulation after it fell short last year.

With a divided Congress and the retirement of one of VALID's most prominent supporters in the Senate, however, the bill's prospects are somewhat cloudy.

VALID aims to resolve the issue of LDT regulation by creating a risk-based framework for in vitro clinical tests (IVCTs) — which would include both IVDs and LDTs — with high-risk tests, such as novel assays, required to go through US Food and Drug Administration premarket review, and lower-risk tests allowed on the market after passing through technological certification. The law would grandfather in LDTs currently in clinical use.

VALID was introduced in the House this week by Rep. Larry Bucshon, R-Ind. and Rep. Diana DeGette, D-Colo., both of whom also introduced the bill in the previous Congress.

It is less clear how things might proceed in the Senate. There, VALID was introduced during the last Congress by Sens. Michael Bennet, D-Colo., and Richard Burr, R-N.C. Bennet remains in the Senate, but Burr has retired. As the former ranking member on the Senate Committee on Health, Education, Labor, and Pensions (HELP), Burr was one of VALID's leading supporters. He has been replaced as ranking member on the HELP committee by Sen. Bill Cassidy, R-La. Cassidy expressed reservations about the bill during a HELP committee hearing last year and advocated for an amendment introduced by Sen. Tommy Tuberville, R-Ala., that would have exempted LDTs developed at academic medical centers from FDA regulation under VALID.

Meanwhile, Sen. Patty Murray, D-Wash., also a staunch supporter of VALID, has moved from her position as chair of HELP to chair of the Senate Appropriations Committee.

"I think the roles of ranking member Burr and chairperson Murray last year in the HELP committee were enormously instrumental in the revisions to VALID and to moving it as far forward in the legislative process as it has ever gone," said Susan Van Meter, president of the American Clinical Laboratory Association. "With Mr. Burr's retirement and chair Murray moving from HELP to [appropriations], that likely has a downward impact on the chances of VALID moving forward this year."

Additionally, this reshuffle has occurred against the backdrop of a newly divided Congress and a looming debt ceiling battle that is likely to dominate lawmakers' attention.

Last year, VALID's proponents eyed the reauthorization of the Medical Device User Fee Amendments (MDUFA), a must-pass legislation to which the bill could be attached. This year, reauthorization of the Pandemic and All-Hazards Preparedness Act has been raised as a likely vehicle for the bill.

One factor that could drive a reconsideration of VALID is the FDA's recent announcement that it is working on plans to regulate LDTs through the rulemaking process. The agency's authority to regulate LDTs remains a matter of dispute, and any efforts by it to do so would almost certainly face legal challenges. Nonetheless, the FDA said it is moving forward with the rulemaking process while also continuing to advocate for VALID, arguing that the former approach would be less advantageous to labs and test developers than the latter.

This is very likely true for the IVD industry, which already operates under the FDA's oversight and for which VALID and features of the bill, like the technical certification pathway, could provide a new, more flexible and more streamlined regulatory process. For LDT developers the calculus is a bit more complicated as it depends on the difficult question of how likely the FDA is to succeed in regulating these tests via rulemaking.

"Certainly the broader industry would benefit from VALID being the new way that FDA regulates these tests, but under their current authority, FDA would have to rely on the existing medical device regulations," said Zach Rothstein, executive director at industry group AdvaMedDx, which represents a number of IVD firms.

Reforming diagnostics regulation within the existing FDA framework would be an uneasy fit, Rothstein said. "If FDA were to go forward ultimately with regulating LDTs under the current structure, I think the LDT community really needs to think about [whether] they maybe want to come back on board with talking about VALID."

Academic medical centers were one of the most prominent and effective sources of opposition to the bill last year, with organizations like the American Association for Clinical Chemistry (AACC) and the Association of American Medical Colleges (AAMC) advocating against it. Burr's office attempted to address these centers' concerns at the end of 2022 by writing an exemption for academic medical centers into a late draft of the bill, but it was deemed by some to be too narrowly written to be meaningful.

AACC remains steadfast against VALID and similar legislation, with President Shannon Haymond telling 360Dx that the organization is "anticipating the reintroduction of VALID" and "will continue to oppose any legislation that seeks to extend FDA oversight to clinical laboratories that are already regulated under CLIA."

She added that AACC will "continue to vigorously oppose FDA's efforts to regulate [LDTs], whether those efforts come in the form of legislation or the rulemaking process."

AAMC appears somewhat more open — at least in theory — to the idea of FDA oversight of LDTs. Heather Pierce, the organization's senior director of science policy and regulatory counsel, told 360Dx that it is "entirely willing to continue these conversations as we have with both the Hill on legislative approaches and with the FDA."

Pierce highlighted several specific parts of VALID that the organization finds problematic, including a lack of clarity around what tests would be grandfathered in under the law and how updating those tests might affect their status, and a concern that the test threshold for exempting assays for rare diseases is too low.

Under VALID, tests "developed to diagnose a unique pathology or physical condition of a specific patient or patients" were exempt from regulation under the law, provided the test wasn't intended for use in more than five patients and wasn't included on the performing lab's test menu or in its marketing materials.

Pierce said that the five-patient threshold, though subject to upward revision by HHS, was too low to make sense given the practical realities of academic medical center laboratories.

"The issue with the number of five is that if an institution couldn't be sure that there would be four rather than six patients [needing the test] … there certainly might be a decision not to move forward with developing that test," she said, adding that a higher but still relatively low threshold, like 100 patients, could give academic medical centers more confidence in this regard.

AACC, as well as other VALID opponents like the Association for Molecular Pathology (AMP), continue to advocate that any forthcoming LDT regulation be handled via modernization of CLIA rather than through the FDA.

AMP Executive Director Mary Steele Williams said that the organization has "reconvened a working group of CLIA experts to update" its 2015 CLIA modernization proposal, which included a framework for increasing oversight of LDTs through CLIA.

In 2021, AMP, AACC, and a number of other lab and medical organizations issued a letter to Reynolds Salerno, director of the division of laboratory systems at the US Centers for Disease Control and Prevention and designated federal official of the US Clinical Laboratory Improvement Advisory Committee (CLIAC), advocating that CLIAC take up the question of LDT regulations and how they could be modernized under CLIA.

In comments to 360Dx last year, though, Salerno said that CLIA modernization "would not provide the necessary oversight of LDTs" and that "regulating diagnostic tests is within FDA's purview."

Neither AMP nor AACC directly addressed Salerno's comments when asked if they suggested that LDT regulation via CLIA modernization was unlikely, but both maintained that CLIA modernization was the appropriate way forward on LDTs.

"We are hopeful that federal agencies will eventually support efforts to discuss and update the laboratory-developed test provisions of the CLIA regulations," AACC's Haymond said.