The Food and Drug Administration (FDA), which has massively screwed up COVID-19 testing, now wants to apply its vast bureaucratic acumen to all other lab-developed tests (LDTs). By insisting on its hidden approval procedures, the FDA early in the pandemic stymied the launch of COVID-19 tests developed by numerous academic and private labs. In contrast, public health authorities in South Korea gave the green light to an effective test for Covid-19 just one week (and several more in the following weeks) after asking representatives of 20 private medical companies to produce such tests .
LDTs are in vitro diagnostic tests for clinical use designed, produced and performed by individual laboratories. They can diagnose diseases and guide treatments by detecting relevant biomarkers in saliva, blood or tissues; the tests can identify small molecules, proteins, RNA, DNA, cells and pathogens. For example, some assess the risks of developing Alzheimer’s disease or guide breast cancer treatment.
The FDA now wants to regulate these tests as medical devices that must undergo premarket review by the agency before doctors and patients can use them. The FDA estimates that between 600 and 2,400 laboratories currently offer 40,000 to 160,000 tests. Overall, approximately 3.3 billion in vitro tests are administered to patients each year.
Out of billions of tests provided, how often do lab-developed tests appear to cause harm? In its remarks, the FDA justifies this burdensome oversight by citing problematic medical device reports and unconfirmed “allegations” for a combined total of nine and four different tests between 2009 and 2023, respectively. The other examples cited by the FDA are tests that were were actually submitted to the agency for review and were subsequently rejected or revised as recommended.
A 2023 study in American Journal of Clinical Pathology analyzed how often these tests were implemented in the University of Utah Health System. Researchers reported that of the more than 3 million lab tests ordered in 2021, 94% of them had already been approved by the FDA. Only 4% of laboratory tests were LDTs. They believe their data is similar across the U.S. healthcare landscape.
The FDA has received strong and widespread resistance from laboratories and doctors. In a letter to the agency, American Hospital Association Executive Vice President Stacey Hughes wrote of the proposed regulation that “the unfortunate outcome would likely be a decline in the rate of clinical innovation, which would negatively impact the ability of United States to keep our health care system at the forefront of discovery, provide quality care to patients, and respond rapidly to emerging public health risks.”
The Biden administration aims to finalize the regulations in April. However, MedTech Immersion According to some reports, analysts at investment bank TD Cowen suggest that “it is unclear if and when the FDA will finalize the rule as it has faced considerable opposition and will likely be challenged in court.”
This article originally appeared in print under the headline “The FDA will test more tests.”