Regulatory Focus™ > News Articles > FDA Form 483: Theranos Initiated Trials Without IRB Approval

FDA Form 483: Theranos Initiated Trials Without IRB Approval

Posted 09 September 2016 | By Zachary Brennan 

FDA Form 483: Theranos Initiated Trials Without IRB Approval

The US Food and Drug Administration (FDA) on Friday released a Form 483 issued 18 August to blood testing startup Theranos, citing the company for allowing patients to consent to sample collection in two Zika-related trials without approval of an institutional review board (IRB).

The one-page FDA report says that the three-day inspection of Theranos' Palo Alto, CA facility in mid-August uncovered evidence that Theranos initiated clinical investigations for two clinical trial protocols and collected samples from subjects without IRB approval.

This is Theranos' third Form 483 from FDA, the first two came last October and included 14 observations, with several deficiencies cited on the design of its Nanotainer device and on how the company deals with complaints.

In March, the company "proactively suspended testing associated with any affected areas last year after learning of the issues" cited by the Centers for Medicare & Medicaid Services (CMS), "which allowed us to ensure comprehensive resolution of any issues identified by CMS, or identified in our own reviews, before patients are tested on any of the instruments impacted."

According to a Wall Street Journal report last week, Theranos voluntarily withdrew its Zika test from FDA review because of the findings highlighted in the Form 483. The letter, which includes only one observation, has redacted sections that would indicate what protocols were impacted by the failure to obtain IRB approval.

According to a presentation from CEO Elizabeth Holmes, who is trying to appeal sanctions imposed by CMS, the company ran a trial of its Zika test in 77 healthy volunteers in the US and 30 Zika-symptomatic volunteers in the Dominican Republic, and another one in 78 participants from US (healthy and febrile subjects) and 102 from Dominican Republic and Colombia (Zika symptomatic).

The trials attempted to compare Theranos’ test, which was submitted to FDA for emergency use authorization (EUA) before it was withdrawn, with a US Centers for Disease Control assay and the Altona Diagnostics RealStar assay. The company did not respond to a request for comment.

Ten other Zika assays have received the EUA designation, including two from CDC and ones from Roche, Hologic and Siemens.

Form 483


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