Startup Theranos rocketed to the forefront of the health industry touting a need for only a few drops of blood to run lab tests--but after a vist from the Food and Drug Administration, the company is now drawing blood from patients through needles like a traditional lab.
The FDA paid a surprise visit to Theranos' office in Palo Alto, California, and concluded from its inspection that the "nanotainers" the company uses to collect and store blood are an unapproved medical device, a person familiar with the matter tells the Wall Street Journal.
The company is now only using its nanotainers for one test, which detects herpes and has FDA clearance.
This news comes just a day after the WSJ ran an in-depth look at Theranos' business practices, revealing that the company, according to former employees, is only using its flagship testing machine for a small portion of its tests.
In addition, the employees voiced concerns to the WSJ about the accuracy of the Edison machine, which is used to test the blood samples. One employee complaint to regulators alleged that Theranos failed to disclose the results of a report that cast doubt on the accuracy of its system.
Theranos, which is run by Elizabeth Holmes, released a statement calling the WSJ article "factually and scientifically erroneous" as well as saying it is "grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents."
The company had been seen as a rising star in healthcare, valued at a whopping $9 billion. It also, over the summer, announced a major partnership with Capital BlueCross, through which BlueCross introduced the company's tech and lab services to its members.
To learn more:
- read the WSJ article