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Theranos Inc. was an American privately held corporation that was touted as a breakthrough health technology company. Founded in 2003 by then 19-year-old Elizabeth Holmes, Theranos raised more than US$700 million from venture capitalists and private investors, resulting in a $10 billion valuation at its peak in 2013 and 2014. The company claimed that it had devised blood tests that required very small amounts of blood and that could be performed rapidly and accurately, all using compact automated devices which the company had developed. These claims were later proven to be false.
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References
- ↑ "CLIA Overview". CMS. 11 April 2018.
- 1 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.
- ↑ "Laboratory Developed Tests". FDA. 26 March 2018.
- ↑ "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.
- ↑ 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.
- ↑ 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.
- ↑ Health, Center for Devices and Radiological. "In Vitro Diagnostics - Direct-to-Consumer Tests". www.fda.gov. Retrieved 2018-12-02.
- ↑ 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.
- ↑ "23andMe Warning Letter Climaxes 7-Year Dilemma Over Lab-Developed Tests". MDDI Online. 2014-01-14. Retrieved 2018-12-02.
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