October 28, 2015
By Alex Keown, BioSpace.com Breaking News Staff
PALO ALTO, Calif. – The hits keep coming for embattled blood-testing company Theranos after the U.S. Food and Drug Administration (FDA) called the company’s proprietary Nanotainer tubes an uncleared medical device in inspection reports released Tuesday night.
Although the FDA’s documents are heavily redacted, federal regulators were critical of some of the practices its inspectors observed, including improper classification for its proprietary Nanotainer tubes used for blood specimens. The FDA said Theranos’ Nanotainer blood specimen tubes are not properly filed as a Class II medical device, but are instead being identified as a Class I medical exempt device. As a result, the FDA said Theranos is “currently shipping this uncleared medical device in interstate commerce between California, Arizona and Pennsylvania.”
Theranos, a $9 billion company, received inspections from the FDA between Aug. 25 and Sept. 16 of this year. Following the visits, federal regulators provided the company with Form 483s, which notifies the company of any problems investigators may have found. In total, the FDA listed 13 different concerns. Following the reports, Theranos told Fortune it has “addressed or corrected all the observations at the time of, or within a week of the inspection.”
In July, the FDA approved Theranos’ systems and test for herpes simplex 1 virus. The FDA clearance includes the use of Theranos’ Nanotainer Tubes for tests run by this method, which allow samples to be collected from just a few drops of blood from a virtually painless prick of a patient’s finger.
Other observations made by FDA inspectors include a criticism that a method for addressing complaints regarding a possible failure of the device to meet its specifications were not “reviewed, evaluated and investigated where necessary.”
The FDA was also critical of Theranos’ documentation of its procedures. Federal regulators noted in several observations that Theranos did not provide adequate documentation regarding input requirements or design risk analysis.
The FDA also noted the “design validation did not ensure the device conforms to defined user needs and intended uses.
Theranos and Chief Executive Officer Elizabeth Holmes have been under fire since a Wall Street Journal report alleged the company only performs 10 percent of its blood tests on its proprietary technology and opts to perform the majority of its blood tests using technology acquired from other companies, including Siemens . In the article, the Journal cited several former Theranos employees, as well as the medical records of patients who had used the Theranos blood test. According to the article, the former employees allege the company split testing between its own proprietary Edison machines and technology acquired from other companies. The use of the two separate technologies yielded different results “when testing for vitamin D, two thyroid hormones and prostate cancer.”
Theranos dismissed the allegations, saying they were “grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents.” Theranos said the report also failed to take into account recent developments made in the company’s Edison technology.
Since the Wall Street Journal expose, Walgreens announced it will hold off on expanding blood testing centers throughout its chain of stores until the California-based Theranos can answer allegations about the viability of its Edison blood-testing systems.
