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.