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FDA says some lab tests are not reliable. It wants to change that.

by Mark Mendoza

The Food and Drug Administration (FDA) has proposed a rule to regulate laboratory medical tests, including those used to diagnose cancer and detect abnormalities in fetuses. The agency aims to phase in regulation over the next five years to ensure the safety and effectiveness of these tests. The tests in question are called laboratory developed tests (LDTs), which are developed and used in a single laboratory as screening and diagnostic tools.

The FDA Commissioner, Robert M. Califf, stated that these widely used tests are not generally coming to the FDA for review, and this situation is one of the most significant gaps in the US healthcare system. Patients may make the wrong treatment choices based on unreliable information from these tests. If the rule is finalized, the FDA would likely require at least some of the tests, including cancer and genetic prenatal screening tests, to go through agency review before being offered to patients.

However, the proposed regulation is facing opposition from groups representing academic medical centers that develop their own tests and from large commercial laboratories. These groups argue that FDA regulation would hinder innovation and delay the development of effective treatments for diseases like cancer. They believe that LDTs are not medical devices and should not be regulated as such. They suggest that Congress should determine the role of the FDA in overseeing LDTs.

Legislation to modernize the regulation of LDTs failed last year, prompting the FDA to move forward with its own proposal. Peter G. Lurie, president of the nonprofit Center for Science in the Public Interest, praised the FDA’s efforts, stating that filling this regulatory gap is a significant step.

Critics of the proposed rule may attempt to block it by suing the FDA. Currently, the Centers for Medicare and Medicaid Services regulate clinical labs on cleanliness issues but do not monitor the accuracy of lab tests. Some lab tests are already regulated by the FDA when they are made by manufacturers of testing equipment, such as Roche and Abbott.

Over the years, LDTs have become increasingly complex and versatile. They can measure a variety of substances, including cholesterol, glucose, and DNA, and provide insights into effective cancer treatments. However, the FDA has repeatedly expressed concerns about the increasing risks these tests pose to consumers. In 2015, the agency published a report on poor-quality LDTs that potentially caused harm to patients. Last year, the FDA issued warnings about inaccurate results from certain genetic noninvasive prenatal screening tests.

The nonprofit Friends of Cancer Research supports stepped-up regulation, citing substantial variability in diagnostic tests used to identify cancer patients who are most likely to benefit from immunotherapy. They emphasize that accurate test results are crucial in making informed treatment choices.

While the FDA has long argued that it has the legal authority to regulate LDTs, it has not yet utilized that power. Under the proposed rule, the FDA aims to change that approach. However, the specific details of the new regulatory regime are still uncertain. FDA officials have stated that they are open to alternative strategies, such as grandfathering some tests or using a different approach with certain academic medical centers. They will review public comments on the matter.

The trade association AdvaMed, which includes companies like Roche and Abbott, expressed support for increased regulation of LDTs. However, they prefer if Congress passes legislation outlining the FDA’s authority in this area.

In conclusion, the FDA’s proposed rule to regulate laboratory medical tests, specifically laboratory developed tests (LDTs), has stirred debates among stakeholders. While the FDA aims to ensure the safety and effectiveness of these tests, opposition from certain groups highlights concerns about potential limitations on innovation. The future of LDT regulation will depend on public comments, potential legal challenges, and the decisions made by Congress and the FDA.

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