Blood Testing Company Told to Prove Reliability of it Blood Tests

By George Dvorsky on at

Elizabeth Holmes, the beleaguered founder-and-chief of Theranos, has agreed to publish scientific data that will supposedly affirm the accuracy and reliability of its blood tests. But as a recent inspection report from the US's Food and Drug Administration (FDA) points out, things don’t look good.

Theranos, the makers of an innovative needle-free blood test, has been under intense scrutiny since the recent publication of a damning Wall Street Journal article alleging that the company has been using outside diagnostic equipment to conduct its own blood tests. It was also suggested that the company’s custom-built Edison machines have been producing different results than those generated by conventional diagnostic tools.

In defence, Theranos published a lengthy rebuttal last week dismissing the allegations and affirming its offering, though no actual data was presented to quell concerns. Now, under intense pressure to do so, Theranos CEO Elizabeth Holmes has agreed to publish the data.

As reported in the New York Times, Holmes made the announcement at a conference on Monday night sponsored by the Cleveland Clinic. She said that presenting the data would be more effective than trying to counter “unfair” articles in the media, adding that: “Data is a powerful thing because it speaks for itself”.

This represents a dramatic about-face for the company, which has been incredibly secretive about its proprietary blood test, which can accommodate numerous tests from a few drops of blood extracted by a simple finger-stick, rather than a needle in the arm.

Holmes has said that her company’s primary concern is to submit data to the U.S. Food and Drug Administration instead of making its data public. But observers say this shouldn’t preclude the company from publishing its work in peer-reviewed journals.

“We were never against that,” said Holmes at the conference. “I just always believed that as the FDA decision summaries came out one by one with our data, that actually that would be so much more transparent a model.”

“But that’s OK,” she added, “we can publish our data, and so we’re doing that.”

The details of the data will be of great interest to a number of stakeholders, and drug giants Pfizer and GlaxoSmithKline.

But if recent inspection reports published by the FDA are of any indication, the Theranos story could start to get a lot worse. As reported in Vox earlier today, the FDA is taking issue with Theranos’s failure to sufficiently validate its technology, while finding a number of issues with the company’s lab protocols.

Theranos CEO Agrees to Publish Data Proving Reliability of Its Blood Tests

(Credit: FDA via Vox)

The heavily redacted reports, which were posted in response to a Freedom of Information Act request, can be found here and here.

[ New York Times | Verge | Vox ]

Top image by Getty