Lab tests are pivotal in patient care, and inaccurate results can lead to misdiagnosis. A recent opinion piece from The Washington Post discussed the necessity for FDA regulation of lab-developed medical tests to prevent misdiagnoses. While the FDA currently oversees drugs and medical devices, lab-developed tests lack similar oversight. The proposed FDA plan would require evidence of the tests' effectiveness and be phased in over a period of four years.
The lack of regulation for lab-developed tests, which started in 1976, has become problematic as tests have become more complex. Inaccuracies have been found in tests for a variety of conditions, including lead poisoning and autism. Though opponents argue regulation could slow test development and increase costs, it's crucial to ensure accurate diagnostics, reducing healthcare expenses.
