Why Clinical Labs Must Still Lead on Laboratory-Developed Test Quality

There is regulation, and then there is overreach. In the months since a federal judge in Texas blocked the U.S. Food and Drug Administration from implementing additional oversight around laboratory-developed tests (LDTs), many lab directors have expressed relief. The FDA may have been well-meaning, but many in the industry saw the agency’s proposal as over-regulation. At the same time, others supported the move toward stricter regulations. Nevertheless, the 60 days allotted to appeal the judge’s ruling have long passed. 

Proponents of the judge’s action believe that the Clinical Laboratory Improvement Amendments (CLIA) and the Commission on Office Laboratory Accreditation (COLA) criteria are robust, flexible, and science-backed regulations that are already stringent enough to promote high quality laboratory testing. Additional FDA regulatory layers would have increased testing time, expense, and the risk of impeding innovation, responsiveness, and access to LDTs. The industry might have been more receptive to FDA oversight if the agency had focused on specific LDTs, like those used for oncology or prenatal testing, instead of proposing blanket regulations. 

The time and resources needed to meet more stringent FDA criteria could also force the hand of lab directors. Some small- or medium-sized labs might have no choice but to forgo production of specific tests, which could limit the ability for researchers to detect rarer conditions or to support an effective antibiotic stewardship program.

A real need for flexible innovation and delivery

Speedy creation and validation of LDTs is critical in many instances, including detection of rare diseases and pathogens behind emerging infections. Meeting stricter FDA standards would have added up to two years to test development, time we couldn’t afford to wait during a public health emergency. 

The Association for Molecular Pathology (AMP) filed a lawsuit in August 2024 to block the FDA’s final rule, citing the agency's lack of authority to regulate LDTs. Although the AHA requested that hospital and health system LDTs be excluded from the FDA’s final rule, the agency proceeded without making that exception. The AHA expressed concern that the FDA’s regulation of LDTs as medical devices would lead to unnecessary and costly paperwork.

Mpox serves as a prime example of the need for flexibility in developing LDTs. During the peak of the outbreak in summer 2022, for example, the CDC reported there were 21,798 undiagnosed cases in the US. By the time an FDA-cleared test was available, there would be a lot fewer infected people on which to test its validity and consistency. 

Currently, LDTs can be created and implemented in a matter of weeks or months. There is strength in this agility. 

Industry inconsistencies?

The FDA likely sought stricter LDT regulations after the quality of some prenatal and oncology tests came into question. These instances prompted the FDA to act, even if the inconsistencies were few and far between. The agency believed it was difficult to guarantee uniformity when laboratories were creating their own tests. 

However, CLIA and COLA officials routinely inspect testing laboratories and continuously monitor test performance, consistency, and validation. Inspectors audit the data and documents labs are required to maintain to ensure quality and report any incidents on an ongoing basis. In addition, because CLIA falls under the purview of the Centers for Medicare and Medicaid Services, a federal agency is already overseeing lab quality and consistency. 

This does not mean the FDA is completely out of the picture. The agency still regulates claims made by testing laboratories around product marketing and messaging. 

Other quality reassurances

Manufacturers of the scientific components that LDTs use need to follow Good Manufacturing Practices (GMPs) and International Organization for Standardization (ISO) quality management system (QMS) to elevate the level of trust in LDTs. Qualified, highly trained leadership and personnel are needed to meet all these standards and practices consistently and without exception. 

CLIA and COLA mandate roles and requirements of lab leadership and testing personnel. Labs are required to staff multiple high-level positions, and each position must meet specific credentials and years of experience. Investing in certified and experienced lab leaders, techs, and staff ensures excellence and strengthens a long-term commitment to quality. 

Quality assurances also extend to the raw materials that go into creating LDTs. Labs yielding tests with indeterminate results on a regular basis can improve their quality, for example, by choosing best-in-class testing material suppliers to ensure consistency, reliability, and validity of testing components.

Perform internal audits

No laboratory director wants to have to respond to a negative audit. It’s better to be proactive and make every effort possible to meet quality and consistency standards. Conduct regular internal reviews rather than waiting for a future surprise audit. Insist that staff maintain robust documentation at all times, so your lab is complying. Document all staff credentials and qualifications. 

Going beyond minimum quality requirements can also mean anticipating and preparing for upcoming regulatory changes. The details of government and industry oversight can change at any time. Remaining proactive and informed helps safeguard against the disruptions of regulatory back and forth in the future. 

Oversight of the laboratory testing field must balance safety with speed and innovation. CLIA and COLA have demonstrated for decades they can achieve both. Many lab directors applauded the judge’s decision to vacate additional FDA oversight, but the conversation about LDT regulation is not over. Laboratories should lead by example, adhering to industry standards and exceeding minimum quality and consistency benchmarks. Leaders and staff should continue to be driven by data, bound by existing rigorous standards, and focused on improving the quality of laboratory testing for decades to come.