New US FDA Rule Tightens Scrutiny on Clinical Laboratories

The United States Food and Drug Administration (FDA) announced a new rule with tougher guidelines for clinical laboratories on Monday, April 29, 2024. The new rule gives the agency more oversight of diagnostic tests developed by the laboratories.

For many years, the U.S. FDA had allowed labs to use their in-house tests to diagnose a range of conditions, if they met certain standards, without the need for the traditional authorization process. However, the agency said the risks associated with most modern lab-developed tests (LDTs) are greater now with the larger and wider use of the tests. 

“No one truly knows how many of these tests are out there or who makes which one, let alone which tests have a concerning number of issues such as inaccurate results,” FDA executive director Jeff Shuren told Reuters on a call.

The FDA plans to create a database containing all the available LDTs and related information so that healthcare providers and patients will be better informed, according to Shuren. The new rule will require that these tests meet the same requirements as other diagnostic tests from medical device makers. The FDA will also review their applications and the reporting of adverse events.

The FDA will phase out previous LDTs guidelines in four years

According to the FDA, the old approach to LDTs will be phased out over four years. However, the agency will continue to regulate some LDTs using the old approach. This includes those that were first marketed before the final rule and those cleared by the New York State’s Clinical Laboratory Evaluation Program (CLEP).

According to Jefferies, a brokerage, no fewer than 5% of LabCorp’s diagnostic testing volumes are LDTs. That of their rival, Quest Diagnostics, is 10%. Virtually all the LDTs marketed by Quest Diagnostics and LabCorp are CLEP-approved, said Elizabeth Anderson, an analyst with EvercoreISI. 

The new rule is expected to lower the regulatory burden as well as limit ongoing approval costs for the test providers, added Anderson.