Behind a full-on public relations initiative, Theranos' embattled wunderkind CEO Elizabeth Holmes continued to beat the transparency drum in an article in Bloomberg Businessweek published this week amid the fallout from a Wall Street Journal article earlier this fall that was highly critical of the company.
In the Bloomberg story, which was an overview of the company's situation and response to mounting criticism over its testing technology that has followed the WSJ article calling the Theranos business model and testing devices into question, Holmes continued to reiterate a pledge she began making early last month that the company promises to boost transparency and would publish data that would validate the accuracy of its tests.
In the meantime, the FDA's push to regulate the molecular diagnostics industry as a whole continued to gain momentum with a report it presented to Congress two weeks ago.
She told the publication that a group of independent medical experts will spend two days in the company's labs this month to examine the technology, data, and regulatory filings, after which they will be allowed to talk publicly about their findings. Holmes also said the Cleveland Clinic will run a study comparing Theranos' results with traditional blood draws and will publish their findings.
Additionally, the company is putting together a medical advisory board that will bring more scientific and regulatory expertise, as well as preparing "manuscripts" containing Theranos' testing data previously submitted to the FDA. That information, she told Bloomberg, will be published in a medical journal. Which journal and when it might be published, however, she wouldn't say.
"What we need to do now is focus on the technology and focus on the science and the data and put that out there," she told Bloomberg. "Because that speaks for itself."
The WSJ exposé targeted Therano's proprietary testing technology. One story showed that the Palo Alto, CA-based company's lab device only handled a small fraction of its tests by the end of 2014. Another article said that Theranos stopped collecting tiny vials of blood drawn from finger pricks for all but one of its more than 200 tests after the FDA paid a surprise visit in August and September.
Holmes was asked by Bloomberg if the company is currently running any patient samples on its own analyzers versus those devices made by other manufacturers. Her reply, "We can run them on our analyzer, but it depends on the test order."
- check out the Bloomberg Businessweek article