Regulating Laboratory Tests: What Framework Would Best Support Safety and Validity?

The dangers of faulty laboratory tests have been highlighted recently because of reporting on the collapse of Theranos owing to fraudulent claims about its blood tests¹ and a New York Times investigation finding 85% false-positive rate among prenatal tests.² Patients have learned in these and other cases, including around the COVID-19 pandemic, that many of the tests they trust for their clinical care have never been formally evaluated by the Food and Drug Administration (FDA).³ Perhaps the most common of these non–FDA-reviewed tests are laboratory-developed tests (LDTs), which are “designed, manufactured and used within a single laboratory.”⁴

After years of calls for reform, the Verifying Accurate Leading-edge IVCT [In Vitro Clinical Test] Development (VALID) Act of 2022,^5, 6 which was championed by the FDA and some congressional leaders, seemed to portend a change in the FDA’s approach to LDTs. The VALID Act would have overhauled regulation of LDTs, but it failed to get through Congress, including in a year-end Food and Drug Omnibus Reform Act signed by President Biden in December 2022. After another push in 2023,⁷ the legislation stalled again. In 2024, the FDA finalized regulation on its own, intending to pursue some overhaul by regulation what could not be achieved through legislative reform.⁸ In this article, we discuss the rationale for changes to oversight of LDTs and the potential impact of some of the key proposals pursued by Congress and the FDA, first in the VALID Act and then in recently finalized regulatory changes.

References

1. Waltz E. After Theranos. Nat Biotechnol. 2017;35(1):11-15. doi: 10.1038/NBT.3761
2. Kliff S, Batia A. When they warn of rare disorders, these prenatal tests are usually wrong. New York Times. January 1, 2022. Accessed April 12, 2024. https://www.nytimes.com/2022/01/01/upshot/pregnancy-birth-genetic-testing.html
3. Clark A, Gallardo A, Deam J, Elba M. They trusted their prenatal test. They didn’t know the industry is an unregulated “Wild West.” ProPublica. December 6, 2022. Accessed April 12, 2024. https://www.propublica.org/article/how-prenatal-screenings-have-escaped-regulation
4. Laboratory developed tests. US Food and Drug Administration. September 27,2018. Accessed April 12, 2024. https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests
5. HR 4128, VALID Act of 2021, 117th Congress (2021). Accessed April 12,2024. https://www.congress.gov/bill/117th-congress/house-bill/4128/
6. S 4348, FDASLA Act of 2022, Subtitle C, 117th Congress (2022). Ac-cessed April 12, 2024. https://www.congress.gov/bill/117th-congress/senate-bill/4348/
7. HR 2369, VALID Act of 2023, 118th Congress (2023). Accessed April 12,2024. https://www.congress.gov/bill/118th-congress/house-bill/2369
8. Medical Devices: Laboratory Developed Tests, 89 Fed Reg 37286 (2024). Accessed May 1, 2024. https://www.federalregister.gov/public-inspection/2024-08935/medical-devices-laboratory-developed-tests