clinical chemistry analyzerPhoto credit: Wikimedia CommonsWASHINGTON – In response to calls for the Food and Drug Administration (FDA) to regulate laboratory-developed tests, AACC released a position statement on Feb. 22 strongly recommending that the Clinical Laboratory Improvement Amendments (CLIA) remain the primary mechanism for overseeing these tests. CLIA has a proven track record of ensuring that labs provide accurate test results that enable patients to receive the care they need, and its regulations can be modified easily to enhance oversight of laboratory-developed tests without endangering patient access to this indispensable service. 

Laboratory-developed tests are created by clinical labs in-house to diagnose new or rare conditions for which no commercial test exists. Under the terms of CLIA, an act that Congress passed in 1988 to establish uniform regulation of laboratory testing, these tests must currently meet stringent performance standards established by the Centers for Medicare and Medicaid Services (CMS). Recently, however, the FDA has proposed filling perceived gaps in CMS’ oversight of laboratory-developed tests by requiring these tests to meet criteria similar to those the agency imposes on commercial diagnostics. These criteria would exist in addition to the CLIA criteria. AACC supports enhanced oversight of laboratory-developed tests, but is concerned that complying with regulations from both FDA and CMS could cripple hospitals and smaller labs and force them to stop performing these vital tests. In order to safeguard patient access to critical testing services, AACC advises Congress and CMS to modernize CLIA’s standards instead of expanding FDA authority.

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FDA’s primary concern about laboratory-developed tests is that CLIA does not make labs demonstrate the clinical validity of these tests. However, under CLIA, more than 8,000 labs are already inspected by the College of American Pathologists (CAP) or the Joint Commission—CMS’ deemed accrediting organizations—which do require clinical validation of laboratory-developed tests. In light of these facts, AACC believes that expanding this requirement to all labs performing laboratory-developed tests under CLIA is viable, and would ensure that laboratory-developed tests are effective without introducing the prohibitive burden of dual FDA-CMS oversight. AACC recommends that CMS implement this new requirement by hiring and training additional staff to review the validation data for laboratory-developed tests and/or by contracting with third parties to conduct the reviews, in addition to using the existing processes in place through CAP and the Joint Commission.

“Clinical labs have one of the lowest error rates in healthcare, showing that CLIA has done an excellent job of regulating labs so that clinicians get the quality test results they need to make critical decisions about patient treatment,” said AACC CEO Janet B. Kreizman. “AACC urges Congress and CMS to update the already rigorous CLIA framework, as we firmly believe this is the most effective way to improve oversight of laboratory-developed tests while still fostering innovation and enabling labs to meet the changing needs of patients.”