Devices & Diagnostics, Hospitals

Theranos CEO wants to make blood tests less painful and easier to get (video)

Theranos CEO Elizabeth Holmes' appearance at TEDMED 2014 this week drew a lot of attention as the company prepares with Walgreens to roll out physician-ordered diagnostic test collection centers at stores around the country.

Theranos CEO Elizabeth Holmes’ appearance at TEDMED 2014 this week drew a lot of attention as the company prepares with Walgreens to roll out physician-ordered diagnostic test collection centers at stores around the country. She noted that lab decisions drive 70 percent to 80 percent of clinical decision-making. In an area with relatively little price transparency, she is positioning her company to take a more patient-friendly approach to how blood tests are ordered and carried out.

The company requires less blood to do tests (which is manna from heaven as a parent of a young child recounted to me) and offers prices side by side the tests listed on its website. But that transparency hasn’t yet extended to an explanation of the technology behind its tests. The lack of validation studies in peer-review journals has peeved the diagnostic community. A recent Fortune interview with CEO Elizabeth Holmes could only squeeze out that “the company uses ‘the same fundamental chemical methods’ as existing labs do. Its advances relate to ‘optimizing the chemistry’ and ‘leveraging software’ to permit those conventional methods to work with tiny sample volumes.

“We see a world where everyone knows ahead of time how much a test will cost,” Holmes said. “By making the costs of tests so low, it becomes possible to engage individuals in the testing process.”

A company that can attract to their board of directors two former U.S. senators, three former cabinet members, a couple of former military commanders from the Marine Corps and Navy and, most recently, a former director of the Centers for Disease Control is interested in shaking things up. Theranos is certainly positioning itself to do just that in the diagnostic world.

In the company’s defense, it uses CMS certified labs and lab developed tests do not currently require FDA clearance. Still, Holmes has told Fortune that the company is pursuing FDA approval anyway.

At TEDMED’s Hive section, Theranos offered blood tests to evaluate cholesterol levels and I participated. I couldn’t take pictures of anything but they warmed up my index finger before they pricked it and then milked it like dairy farmers squeezing milk out of cows the old fashioned way. It looked quite a bit more than a drop but much less than would typically be required and with my baby veins, the phlebotamist didn’t have to use a blood pressure cuff to get it.

Theranos’ work could raise the patient data ownership debate to new levels if it succeeds at granting consumers greater access to and control over their diagnostic tests, eclipsing a discussion that has been limited mostly to wearables and electronic health records.

Update: This story has been updated to include video clip of Elizabeth Holmes’ talk at TEDMED 2014

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