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The FDA announced a final rule that would put lab-developed tests under the same review process as medical devices, potentially slowing clinical trial efforts, critics say.
LDTs, or in vitro diagnostic products (IVDs), are developed by single laboratories and used in clinical settings and in a variety of assays ranging from genetic testing to COVID-19 testing.
These comments have been received since this rule was first proposed. 6,700 comments During the public availability period last fall, many argued that it would limit access to the test and harm clinical trials. In response to comments, FDA updated its phase-out policy to provide a four-year plan for IVDs to meet the new requirements and include additional exceptions. Laboratories that make LDTs are already regulated under the Clinical Laboratory Improvement Amendments of 1988 to meet these requirements, but the FDA said the new rule strengthens the regulatory framework.
“By applying the same general oversight approach to laboratories and non-laboratories that manufacture IVDs, the FDA Reduce regulatory uncertainty“This will provide additional stability, clarity, and confidence to stakeholders and encourage investment in the development of innovative IVDs,” the FDA said in a release.
Highlights of the final rule
Despite its widespread use, LDTs are not without limitations, according to the FDA, and although regulators have long debated oversight of the tests, tests have become more complex and ubiquitous over time. It is said that it has become.
2015 agency Highlighting 20 case studies Number of tests that were not up to standard. The best-known case involves the now-defunct blood testing company Theranos, which produced inaccurate LDTs that were used in clinical practice before the Centers for Medicare and Medicaid Services. Laboratory’s CLIA certification revoked In 2016. Then it fell apart And its top leaders were indicted for fraud.
This problem of oversight was also evident early in the pandemic when diagnostic tests were unavailable and laboratories were unable to distribute LDT due to emergency use authorization requirements at the time.
The final rule defines LDTs similarly to medical devices for regulatory purposes, allowing FDA a more active and traditional oversight process. By May 2028, laboratory-manufactured IVDs will be required to be fully compliant with new regulations under the direction of the FDA. phase out Make a four-year plan. According to the regulator, “the benefits of the phase-out policy outweigh the costs.” The agency also said the benefits of the policy will become clearer over time as more LDTs are brought to market.
One loophole the FDA included is that LDTs already available under the old policy and LDTs designed to fill an “unmet need” do not have to comply with the new market standards. Ta.
Concerns about clinical trials
When the rule was first proposed last year, drug companies weighed its potential impact on clinical trials. Eli Lilly used an academic medical center-produced LDT (different from one produced by a commercial laboratory) in a clinical trial of its cancer drug Retevmo, but the academic medical center-produced LDT did not identify the patient population. He pointed out that this could accelerate enrollment in clinical trials. as soon as you can. Conversely, centralized testing “can lead to significant delays,” the company said, referring to its experience with precision clinical trials in oncology.
“Lilly emphasizes the importance of ensuring patients have continued access to diagnostic tests through AMC laboratories, and that results , enabling greater and more efficient access to clinical trials.” . “We believe that if the proposed rule is implemented as proposed, significantly reduced The amount of testing that AMCs perform limits access to clinical trials in the communities they serve. ”
Regeneron Pharmaceuticals generally supported the proposed rule in comments to FDA, but also noted potential barriers to implementation, such as delays in clinical trials.The company criticized the FDA lack of definition Comparison between assays in the clinical setting and assays in clinical trials.
“If IVD regulations are applied too broadly and do not provide enough flexibility to use well-characterized assays in clinical studies, the initiation of clinical trials will be delayed and subsequent new treatments for patients in need will be delayed. There may be delays in accessing the law,” said Vice President Dr. Edward Cox. Cuancha-Maria Manning, head of regulatory affairs and senior director of regulatory intelligence at Regeneron, wrote in the company’s comments:
Now that this rule is finalized, the lab tech industry has the following possibilities: Start a legal challenge. The rule is also outside the FDA’s jurisdiction, according to the American Clinical Laboratory Association.
“ACLA has serious concerns about this rule as both a matter of policy and law,” the association, which represents diagnostic laboratories, said in a statement shortly after the final rule. “This rule would limit access to many important tests, increase health care costs, and undermine innovation in new diagnostics. Exceeds FDA’s Statutory AuthorityThis is because Congress has never given the agency authority to regulate laboratory-developed testing services provided by laboratory professionals. ”
