- On Friday, the US Food and Drug Administration (FDA) said that it intends to step up its oversight of laboratory-developed tests to ensure their safety and effectiveness.1
- The proposed rule would formally bring thousands of tests performed in large laboratories under the FDA's regulatory authority.2
- According to the FDA, the change would treat laboratory-developed tests as medical devices and require manufacturers to register their kits with the FDA.3
- The tests, primarily developed and used by high-tech laboratories, include tests for cancer, heart disease, autism, Alzheimer's, and sexually transmitted infections, among others.4
- The FDA claims most laboratory-developed tests were previously 'lower risk, small volume.' However, today, 'clinical diagnostic tests are being offered as laboratory-developed tests without assurance that they work.'5
- Meanwhile, King & Spalding, an international law firm representing laboratories behind such tests, stated that 'the proposed rule will be open for public comment and likely will be challenged in court.'2
- Pro-establishment narrative, as provided by ProPublica. Unregulated laboratory-developed tests, which have long skirted FDA oversight, pose a growing risk to patients because of potentially inaccurate results. The proposed rule would end decades of regulatory ambiguity and ensure the tests are safe, accurate, and reliable.
- Establishment-critical narrative, as provided by Senate. Before it tries to close the so-called loophole that has allowed laboratory-developed tests to bypass oversight for decades, the FDA must prove it has the authority to regulate these tests and examine the potential impact of its proposed regulation on the diagnostic industry.