Labs Express Concern about Testing Access if FDA Regulates LDTs

Nearly 85% of respondents to an ARUP Laboratories survey on the impact of the FDA’s proposed rule to regulate laboratory-developed tests (LDTs) believe the proposal will hurt their laboratories and, ultimately, patient care. 

Most respondents were either “extremely concerned” or “very concerned” about the impact of the proposed rule on patient access to essential testing and innovation, the financial and personnel resources required to comply, and the FDA’s ability to implement the proposed rule.

Further reading: Is There a Balancing Point for LDT Regulations?

Survey: The FDA’s LDT Regulation

The survey is the largest exploration of the impact of the proposed rule on clinical laboratories to date. Of 503 respondents, only 41 (8.2%) support the FDA’s proposed rule. A total of 83.9% of respondents believe the proposed rule will negatively impact their laboratories, whereas only 3% believe they have the financial resources to pay FDA user fees, which can be as high as $483,000 for “high-risk” premarket authorization submissions, according to the survey. Additionally, nearly 61% of participants say they would likely remove tests from their laboratory menus if the proposed rule is enacted, and an additional one-third of respondents are not yet sure what they would do.

“This survey shows there is profound concern within the clinical laboratory community about the proposed rule and its negative impact on patient care,” says Jonathan Genzen, MD, PhD, ARUP’s chief medical officer and senior director of governmental affairs. “If labs cannot afford to comply with the proposed regulations, they will have to discontinue essential tests, and that harms patients.”

A detailed exploration of the survey results and the issues surrounding the proposed rule for labs and patients can be found in a manuscript authored by Genzen and colleagues, publicly available on medRxiv, a health sciences preprint server.

Reaction to FDA’s Proposed LDT Rule

The FDA released the proposed rule in October 2023 and denied numerous requests, including one from ARUP and 88 other industry partners, to extend the public comment period, which closed on Dec. 4, 2023. Approximately 6,700 public comments were submitted during the open comment period, although many were form letters. To better understand how clinical laboratorians perceive the proposed rule, ARUP Laboratories conducted a survey of the clinical laboratory community.

“I was disheartened by the rushed nature of the public comment process, given the legitimate risks to public health if the rule moves forward. Once the comments were available for review, we also quickly realized there’s not a reliable mechanism to analyze public comments quantitatively by the clinical laboratory sector, so we decided to proceed with our own survey. This project compiles valuable information from hundreds of clinical laboratorians in a way that is easy to access, share, and interpret,” Genzen says.

Most respondents identified themselves as lab managers, lab supervisors, lab directors, lab employees, medical directors, pathologists, physicians, clinicians, or PhD scientists, says ARUP Laboratories. They were also provided an open-text field for feedback, and 63 left additional comments, with only one supporting the FDA’s proposed rule. Many opposed the proposed rule with comments, including the following:

“If this rule is finalized it is going to adversely impact patient care and health equity.”

“…The FDA proposed rule is akin to a sledgehammer approach to a problem that requires scalpel intervention.”

“…This would have a significant impact to the community we serve and to public health as a whole.”

“…Additional burdens to the LDT process make our country less prepared to handle the inevitable next pandemic.”

“This rule could destroy our lab.”

Defining LDTs

The FDA has defined LDTs as in vitro diagnostic tests (IVDs) that are “intended for clinical use and designed, manufactured, and used within a single clinical laboratory.” As the manuscript by Genzen and his coauthors notes, there is no statutory definition of LDTs from Congress or in current federal regulations, nor are LDTs mentioned in the Medical Device Amendments of 1976, the U.S. law that established the current framework for medical device regulation. Still, the FDA seems intent on moving forward with the proposed rule on LDT oversight, which may be released as early as April, according to the Biden administration’s Unified Agenda.

“The FDA continues to portray a message to the public that lab testing is dangerous, even though the clinical laboratory community prides itself on a remarkable culture of quality and safety and is already highly regulated,” Genzen says. “Over a hundred thousand clinical laboratorians dedicate their professional lives to ensuring high-quality testing and patient care every day in the U.S. Instead of blanket regulation that will stifle innovation and undermine the ability of laboratories to care for unique patient needs, we need to find a mechanism to support labs and patient safety in a more appropriate regulatory framework.”

ARUP Laboratories has urged the FDA to withdraw the proposed rule and to continue to solicit feedback and work with stakeholders to better understand the implications of the proposed rule on clinical laboratories and public health.

Charts: ARUP Laboratories: