In a significant move to address concerns surrounding lab-developed tests (LDTs), the U.S. Food and Drug Administration (FDA) has announced a new rule that aims to improve the oversight of these tests. The decision comes after extensive coverage of issues with LDTs by several media outlets and researchers, including ProPublica articles.

Lab-developed tests, which include prenatal genetic screenings, certain cancer screenings, and tests for rare diseases, have long operated without extensive federal oversight due to their single-lab manufacturing and use. However, increased scrutiny and incidents of faulty testing have prompted the FDA to take action.

The rule, which will be implemented over a four-year period, introduces a series of requirements for test manufacturers. Within two years, test-makers will be expected to meet registration and listing requirements, ensuring transparency about the existence and functioning of these tests. High-risk tests will undergo new FDA review requirements starting in November 2027, while moderate-risk and low-risk tests will follow suit in May 2028.

Notably, the registration and listing provisions are hailed as a critical aspect of the rule, as they will provide crucial information about the number and types of lab-developed tests in circulation. This transparency aims to ensure that patients and healthcare providers can make informed decisions based on reliable and accurate test results.

While the FDA's approach to oversee LDTs has historically been minimal, the agency recognizes the significant impact that these tests now have on healthcare. Due to the absence of federal registration, the exact number of lab-developed tests remains unknown. However, estimates suggest that around 12,000 labs could potentially deploy these tests, with some processing thousands of tests daily.

The decision to implement this rule comes after a ProPublica investigation highlighted the concerning practices of a Chicago-based lab testing company during the COVID-19 pandemic. The company was found to provide unreliable testing services while expanding its reach, despite inaccurately informing infected individuals of negative test results.

Despite widespread support for increased FDA involvement from a large coalition of labs, associations, and academic medical centers, objections have been raised by those concerned about potential limitations on patient access to health services. Some argue that these tests should be regulated through legislation instead of rulemaking.

Nevertheless, FDA Commissioner Robert Califf asserts that the new rule is crucial to ensuring that Americans can rely on accurate test results for important healthcare decisions. The final rule represents a significant shift in the FDA's approach and reflects the agency's commitment to public health.

While criticism of the rule persists, with some arguing that the FDA is exceeding its authority and bypassing the legislative process, the Association for Molecular Pathology, representing laboratory professionals, is currently reviewing the implications of the ruling on its members and patient care.

The FDA's efforts to address the regulation of lab-developed tests go back a decade, with a draft guidance being issued in 2014. However, opposition led the agency to drop the proposal. Subsequent attempts to pass legislation on the matter have faced obstacles.

This long-awaited rule signifies an important step forward in enhancing oversight and accountability of lab-developed tests. It demonstrates the FDA's commitment to ensuring the reliability and trustworthiness of test results for the betterment of public health.