Theranos Inc., already no stranger to accusations about its testing accuracy, is now the subject of a Food and Drug Administration (FDA) probe as a result of another set of complaints from ex-employees. The most recent complaint alleges that Theranos violated research protocols when getting FDA approval for its herpes test in 2014.
Theranos is a Silicon Valley startup lab worth approximately $9 billion, based around its “breakthrough” technology that can perform tests using only a few drops of blood. The machine, called the Edison, received FDA approval to run herpes tests back in July as a result of what the complaint describes as compromised circumstances. Allegedly, Theranos underreported how often the Edison broke down during the study and that one of the components of the device was modified partway through to improve accuracy. While not strictly wrong, making such changes in the middle of a study is generally frowned on as it can affect the integrity of the resulting data.
A spokeswoman from Theranos has stated that the company has not received copies of any recent complaints and as a result it has no way of evaluating what merits it may have, if any. They did add that many complaints regulators receive are not substantiated and that Theranos trusts in the evaluation process.
Although appreciated by doctors for its fast delivery of results and user-friendliness, Theranos has been the subject of several complaints and run-ins with the FDA in the past. In October, former employees alleged that Theranos ran only 15 tests on its Edison machines in 2014, compared to 190 it ran with traditional devices. There were, allegedly, numerous concerns by employees and some doctors about the validity of Edison’s results as they could vary wildly between re-tests of the same samples. Theranos management allegedly knew of these issues but pressured employees to continue testing regardless.
For its part, Theranos has always denied these accusations and stood by its results and the validation methods it follows in accordance with scientific standards. Although the company does use traditional testing machines when performing unusual or rarely-ordered tests, it fully and publicly discloses this information. It does acknowledge the Edison as a work-in-progress and maintains a commitment to its development and success.
To date, Theranos has not been confirmed to be engaged in any wrongdoing.
Sources for Today’s Article:
Carreyou, J., “Hot Startup Theranos Has Struggled With Its Blood-Test Technology,” Wall Street Journal web site, October 16, 2015; http://www.wsj.com/articles/theranos-has-struggled-with-blood-tests-1444881901.
Carreyou, J., “U.S. Probes Theranos Complaints.” Wall Street Journal web site, December 20, 2015; http://www.wsj.com/articles/u-s-probes-theranos-complaints-1450663103?cb=logged0.9712597096804529.