Debate Emerges Over FDA's Plan to Regulate Laboratory Medical Tests

The FDA has finalized a plan to regulate laboratory medical tests due to concerns about reliability and patient risks, leading to debate over access to tests, innovation, and patient care in the medical field.

There are several voices of opposition to the recently approved regulations that focus on the lucrative sector of laboratory-developed tests (LDTs), which are created, produced, and evaluated within a single lab for use in screening and diagnosis. Critics fear increased FDA oversight will hinder the rapid development of new tests, and industry players, including academic medical centers and commercial laboratories, have voiced opposition to the proposed regulations. Some analysts predict that opponents will take legal action against the FDA to prevent the implementation of the new rules, according to reporting by The Washington Post.

The FDA’s plan will regulate lab tests over 4 years, requiring premarket review and adherence to new requirements. Tests already in use will stay on the market to avoid the risk of patients losing access to them because of compliance costs. 

Shares of Quest Diagnostics and LabCorp rose by the end of market trading on Monday, April 29 following this announcement, noted The Washington Post. 

Hospital systems can now use new tests without needing agency approval as long as they address unmet needs, which hospital lobbyists have praised. These LDTs can detect and provide crucial health information about various substances in the body like proteins, glucose, cholesterol, and DNA. Inaccurate results from these tests can greatly influence patient decisions, as seen with a prenatal screening test warning from the FDA in 2022. Reports of women ending pregnancies based solely on false test results highlight the importance of accurate testing.

Decades ago, LDTs were rare, but their prevalence has increased due to the ability to send samples nationwide. Lawmakers have been focused on this issue for years, but bipartisan legislation has not yet been passed.
Hospital systems can now use new tests without needing agency approval as long as they address unmet needs, which hospital lobbyists have praised. These laboratory-developed tests can detect and provide crucial health information about various substances in the body like proteins, glucose, cholesterol, and DNA. Inaccurate results from these tests can greatly influence patient decisions, as seen with a prenatal screening test warning from the FDA in 2022. Reports of women ending pregnancies based solely on false test results highlight the importance of accurate testing.

Decades ago, LDTs were rare, but their prevalence has increased due to the ability to send samples nationwide. Lawmakers have been focused on this issue for years, but bipartisan legislation has not been passed. The FDA issued its own rules due to the lack of guidance. Some lawmakers criticize the rule, while others believe it is necessary for patients' decisions. Share

Reference
Roubein R, Gilbert D. FDA moves to regulate some tests it says may be unreliable. The Washington Post. April 29, 2024. Accessed May 3, 2024. https://www.washingtonpost.com/health/2024/04/29/fda-lab-developed-test-medical/