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FAQs
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What will happen to Theranos: acquisition, sustainable company at lower valuation, or full shutdown and return of investor monie
Hard to say - but I don't see how it gets resolved outside a court of law. The allegations by the Wall Street Journal are serious - and mostly around manipulating proficiency tests (designed to verify the accuracy of testing equipment with great precision - down to machine make and model number - three times a year).If those allegations are true - it potentially throws into question the accuracy of 3.5 million blood tests run by the company to date. The results of those tests were used by millions to make (potentially) life and death healthcare decisions. That's serious liability - and not just just for Theranos. Walgreens may not have vetted the technology as carefully as they would have normally for clinical reasons because this wasn't just a partnership - it was an investment in the company. Lot's of this hinges on the use of their proprietary technology for transporting blood samples (taken via finger-stick) called nanotainer's. The company has since acknowledged that they stopped using these for any test other than the one that was FDA approved (for Herpes Simplex Virus), but when did they stop in the run-up to 3.5 million tests? The FDA has indicated that the nanotainers are considered a Class II medical device and were not approved for any use other than the one test. This is critical because the HSV test is relatively easy - and binary. It's more like a pregnancy test that you can buy OTC. But what about the 3.5 million OTHER tests? How many used "nanotainers" and what testing equipment was used on those samples and was the proficiency testing (for non Theranos invented testing equipment) manipulated in any way as a part of using those nanotainers?We already have strong evidence that at least one test was inaccurate - using the nanotainer - from (ready for this?) a venture capitalist that lives in Silicon Valley - Jean-Louis Gassee (who wrote to Ms. Holmes with questions about his test earlier this year). [1]I'm not an attorney - but the first legal opinion certainly makes it look like the only path forward is through a judicial process. [2]I happen to know that Theranos was using nanotainers - for tests other than FDA approved one for HSV - in July - because I paid for one here in Arizona. Here's a picture of my "nanotainer" with my blood. Now, I'm fortunate because my test was entirely based on curiosity - there was NO medical neccessity, but there are 3.5 million OTHER tests that (arguably) were medically necessary - and where healthcare decisions (potentially fatal ones) were made base on those test results. Hey, feel free to experiment with 23andMe genetic testing - or Uber - or any of a dozen other "disruptive" services. Those are 100% OPTIONAL and as consumers - we have a choice to use or not use the service. No one of clinical authority is ordering a test for us to take in order to render a clinical assessment or judgment - with all the attendant liability. Again, I'm not an attorney - but it's hard to see how this gets resolved for the 3.5 million tests to date - outside of legal action. [1] Theranos Trouble: A First Person Account | Monday Note [2] Here's What Troubled The FDA When It Inspected Theranos This Summer
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