ADLM President: 'LDTs Should Remain under CLIA'

     

Clinical laboratory leaders continue to digest the U.S. Food and Drug Administration’s (FDA) final rule to more strictly regulate laboratory-developed tests (LDTs), which the agency released on April 29.

The Association for Diagnostics & Laboratory Medicine (ADLM) was among the lab industry groups opposed to the FDA’s rule. In this Q&A with Today’s Clinical Lab, Octavia M. Peck Palmer, PhD, FADLM, president of ADLM and vice chair of health equity, diversity, and inclusion at the University of Pittsburgh School of Medicine, gives her thoughts on why LDTs should not be considered medical devices and what ADLM sees as the role for the Clinical Laboratory Improvement Amendments of 1988 (CLIA) when it comes to LDTs.

Palmer’s answers have been lightly edited for clarity.

Were you surprised to see some limited discretionary enforcement remain in the final rule? Is that an olive branch from the FDA to LDT developers?

We anticipated that the FDA would make some modifications in the final rule, particularly regarding grandfathering in existing tests. Based on our initial review of the rule, we believe that the modifications listed in the rule are not sufficient to address the overall concerns about patient access to critical clinical tests. Even with the FDA’s limited changes, the rule is costly, duplicative, and overly burdensome. Many labs will be forced to reduce or discontinue the laboratory-developed tests they perform if this is implemented.

Some critics of the FDA rule say CLIA is best suited for oversight of LDTs, but that CLIA needs to be modernized to be able to do that. Where does ADLM stand on that debate? 

ADLM believes that CLIA works and that is where any changes should be made. The FDA still has not demonstrated what problem they are trying to fix other than the agency lacking direct oversight of laboratory-developed tests. ADLM has long advocated for having discussions at the Clinical Laboratory Improvement Advisory Committee; allowing the advisory committee and other relevant parties to identify what, if anything, needs to be done; and make changes as warranted within the existing regulatory construct. 

The FDA insists that CLIA does not have the expertise to evaluate the clinical utility of laboratory-developed tests. However, more than 8,000 laboratories are accredited by the College of American Pathologists or The Joint Commission—both deemed accrediting organizations under CLIA. Both require clinical validation of any claim relating to the use of laboratory-developed tests for patient care. Considering this, expanding clinical validity to all laboratory-developed tests under CLIA appears to be a viable regulatory option that would achieve the goal of ensuring clinical validity without the prohibitive administrative burden of dual oversight by FDA and the Centers for Medicare & Medicaid Services, which regulates laboratory-developed tests via CLIA.

Do you agree with the FDA’s fundamental point that lab-developed tests and all in vitro diagnostics (IVDs) are medical devices as opposed to medical procedures? Should all IVDs, including LDTs, fall under CLIA oversight? 

Laboratory-developed tests are not medical devices. They are medical services provided by clinical laboratories that provide vital medical data that enable physicians and health care providers to diagnose disease, monitor disease progression, and treat their patients. Laboratory-developed tests are developed in house by highly trained and experienced laboratory directors when there is no test on the market or the tests that exist do not meet the specific need of the physician. Laboratory-developed tests are not test kits or devices that are sold. Medical devices are regulated by the FDA, whereas laboratory-developed tests are, and should remain, under CLIA.

From a COVID-19 testing perspective, what do you think would have happened during the pandemic if this final rule was in effect? Do you think the testing options for the public would have been stifled, or would the government have overridden any limits during the public health emergency?

The entire nation observed the catastrophic effect of the FDA granting a sole-source Emergency Use Authorization to the Centers for Disease Control and Prevention during the initial phases of the pandemic. This severely limited our ability to proactively identify community spread of SARS-CoV-2, which was done through laboratory-developed tests. This new rule would have a similar impact by reducing clinical testing options across all sectors of medical care, from newborn screening to cancer diagnosis and treatment.

Based on what you’ve read in the rule, is ADLM thinking about any legal action against the FDA?

ADLM, like others in the laboratory community, is considering all options as it reviews the rule.