In another blow to embattled blood testing startup Theranos, the FDA posted inspection reports on Tuesday that reveal potentially disastrous pitfalls for the company. The FDA calls the miniature vial used by Theranos to collect blood samples an “uncleared medical device” and notes that the company has been shipping it across state borders. These findings bolster the Wall Street Journal‘s extensive reporting on Theranos over the past two weeks, which stated that the company was now using the vials for its herpes test alone–the only Theranos blood test the FDA has approved thus far.
The FDA documents also argue that Theranos shrugged off customer complaints and did not have an airtight quality control process. “Complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated where necessary,” one report read.
In a statement, Theranos explained that the claims made in the FDA’s report–which was conducted between August 25 and September 16–had since been “addressed and corrected” and that the company had “submitted documents to FDA that say so, including extensive documentation.” Theranos also said it opted to stop using the blood vials, which the company has dubbed “nanotainers,” until the FDA clears the rest of its tests. “We believe this is the right action to take as we wait for clearance of the Nanotainer™ tubes, for which we have submitted all our data to the agency, so that we can be compliant with operating under the FDA quality systems framework in and of itself,” the statement reads. “Over 120 of the tests developed for use on our devices used as part of Theranos proprietary technologies have been submitted in pre-submissions to FDA.”
On Monday night, Theranos CEO Elizabeth Holmes disclosed that the company would make its data available to the public, to combat the numerous allegations set forth by the WSJ. Holmes has vehemently denied the claims made by the newspaper, repeatedly calling its reporting inaccurate; last week, Theranos published a blog post that individually addressed and refuted the numerous damning charges detailed by the WSJ.
[via Wall Street Journal]