Health startup Theranos Inc. has made a name for itself in the industry by offering lab tests that require just a few drops of blood, but four former employees have claimed that this highly touted technology is used for just a small portion of the company's tests, the Wall Street Journal reported.
According to the former employees of the California-based company, who remain unnamed, the technology was used for only 15 out of more than 240 types of tests in 2014.
Further, the four were unsure of the accuracy of the Edison machine, which is used to test the blood samples, they told WSJ. In particular, 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 shot back at the newspaper with a statement, calling the 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 statement goes on to say that more than 1,000 pages of statements and documents were supplied to the WSJ reporter to refute the allegations, but those were not mentioned in the article.
Nonetheless, the WSJ detailed additional suspicions about the tests based on interviews with employees and other information obtained by the newspaper. Employees told reporters, for example, that proficiency-testing samples gave different results when tested with the company's Edison machines and with technology from other companies.
Theranos, founded by Elizabeth Holmes, is no stranger to headlines. Just last summer it announced a major partnership with Capital BlueCross, through which BlueCross introduced the company's tech and lab services to its members. Theranos received lab technology approval from the U.S. Food and Drug Administration one week before the announcement, FierceHealthPayer previously reported.
In early September, FierceHealthIT named Holmes to its 10 Influential Women in Health IT for 2015 list, noting that in July Theranos' test and test system for the herpes simplex 1 virus received a Clinical Laboratory Improvement Amendments waiver from the FDA.
To learn more:
- read the WSJ report
- here's the Theranos statement