In a recent report issued by the U.S. FDA, the agency detailed a need for more authority to regulate medical laboratory testing. The report outlined 20 examples of tests performed by a single laboratory that fall under the jurisdiction of CMS – rather than the FDA – that may have led to patient harm due to vetting and validation issues.
Currently, the FDA typically reviews test systems or kits that are sold by manufactures for use in multiple hospitals, physician offices, or other laboratories. However, laboratory tests performed in a single, centralized location do not require FDA review and approval as long as standards set forth by CMS are met.
The FDA seeks to gain more control in this area, citing that, currently, patients may be incorrectly diagnosed, receive false-positives, or a disease may be missed. Another concern noted by the FDA is the potential for no clear relevance to the disease being tested, which can lead to an increase in costs, estimated by the FDA to be $66.1 million.
“FDA oversight would help ensure that tests are supported by rigorous evidence, that patients and health-care providers can have confidence in the test results, and that laboratory-developed tests have more scientifically accurate product labeling,” wrote Peter Lurie, MD, MPH, the associate commissioner for public health strategy and analysis at the U.S. FDA, in a blog post from the agency.
Sources: U.S. Food and Drug Administration. “Why FDA should oversee laboratory developed tests.” November 16, 2015; Stat News. “FDA warns of dangerous lab tests in bid for regulatory control.” November 17, 2015.