Laboratory developed test

Laboratory developed test (LDT) is a term used to refer to a certain class of in vitro diagnostics (IVDs) that, in the U.S., were traditionally regulated under the Clinical Laboratory Improvement Amendments program.[1]

United States

In the United States, the Food and Drug Administration (FDA) has determined that while such tests qualify as medical devices, these products could enter the market without prior approval from the agency. In 2014, the FDA announced that it would start regulating some LDTs.[2][3] In general, however, it has not done so, as of April 2019.[4]

As LDTs do not require FDA 510(k) clearance required by other diagnostic tests, they have been viewed as a regulatory loophole by opponents.[5][6]

Direct-to-consumer

Direct-to-consumer tests are regulated as medical devices, although they are not necessarily reviewed by the FDA.[7]

23andMe direct-to-consumer genetic tests were originally offered as LDTs, but the FDA challenged that and forced the company to submit the test for approval as a class II medical device.[8][9]

Companies

Several companies offer lab-developed tests.[2]

References
  1. "CLIA Overview". CMS. 11 April 2018.
  2. Pollack, Andrew (2014-07-31). "F.D.A. Acts on Lab Tests Developed In-House". The New York Times. ISSN 0362-4331. Retrieved 2019-05-22.
  3. "Laboratory Developed Tests". FDA. 26 March 2018.
  4. "Oversight Of Laboratory-Developed Tests" (PDF). CAP FAQs, Topic: Laboratory-Developed Tests. College of American Pathologists. 2 April 2019. Archived from the original (PDF) on 21 May 2019. Retrieved 15 December 2022.
  5. Jotwani, Rohan; Boumil, Marcia; Salem, Deeb; Wetterhahn, Madeline; Beninger, Paul (September 2017). "Theranos Experience Exposes Weaknesses in FDA Regulatory Discretion". Clinical Pharmacology in Drug Development. 6 (5): 433–438. doi:10.1002/cpdd.374.
  6. Duhaime-Ross, Arielle (Nov 17, 2015). "FDA wants to close the loophole that Theranos used, but Republicans don't understand why". The Verge. Retrieved 5 April 2018.
  7. Health, Center for Devices and Radiological. "In Vitro Diagnostics - Direct-to-Consumer Tests". www.fda.gov. Retrieved 2018-12-02.
  8. Yarbrough, Knobbe Martens-Daniel K.; Fuller, Michael. "FDA Approval of 23andMe Genomic Test Shows the Way for Direct-to-Consumer Diagnostics | Lexology". Retrieved 2018-12-02.
  9. "23andMe Warning Letter Climaxes 7-Year Dilemma Over Lab-Developed Tests". MDDI Online. 2014-01-14. Retrieved 2018-12-02.


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