Allegations of Data Manipulation At Theranos (wsj.com)

An anonymous reader writes: A lengthy report at the Wall Street Journal brings allegations of data manipulation against blood-testing startup Theranos. The company raised hundreds of millions of dollars from investors, at a valuation of roughly $9 billion, on the hope that they can revolutionize medical diagnosis. They've also made agreements with Safeway and Walgreen's to offer blood tests within stores. But multiple former employees say Theranos was shaky on the science at best, and intentionally misrepresentative at worst.

Engineer Anthony Nugent says the device intended for Walgreen's was still experimental. He also recalls seeing the machines labeled "for investigational use only," because of poor accuracy. A Theranos lab worker "told federal authorities that the results from the quality-control runs diverged from the known amount by more than two standard deviations, a red flag that suggested possible accuracy problems." When that employee notified superiors within the company, somebody came and deleted the quality control data, which made the device's test runs appear better than they were. There are also reports that inspectors and auditors were purposefully kept away from parts of Theranos's lab. A Theranos spokesperson denied everything.

Comments

The tech was never important to me.

[w3woody]

It's a shame Theranos is having so many problems, because to me it was never about blood testing using small volumes of blood, but about low cost DIY blood testing available at places like Walgreens. The ability to walk in and get a Cholesterol test for $3, and a comprehensive metabolic plane for $7 instead of going through a doctor (and paying several hundred dollars for the privilege of having that doctor cluck-cluck at me) is a big deal: it means I could (for example) try different diets and get a blood test monthly to see how those diets affect me.

Re:The tech was never important to me.

[ebrandsberg]

The tech is actually already cheap. A local hospital performs a 35 point blood screening with most of the commonly done tests twice a year for $40 a shot, and they do this as a FUND RAISER. A link to the event from earlier this year (although very short on details): http://www.topofwv.com/ai1ec_event/blood-analysis-weirton-medical-center-2/?instance_id=

The reason that the tests are so expensive in the Dr's office is that they run each one as a distinct test vs. using bulk analysis. They should NEVER just do a "cholesterol" test, but it is more profitable if they split it up.

Cult of personality?

[Facekhan]

After reading TFA, it seems like the company runs like a cult of personality of Ms. Holmes. Their answer for every objection is to impugn the integrity or intelligence of the person who raised the issue. Their remembrance of the facts diverges wildly from the first hand accounts of their critics. Whenever they mention Ms Holmes odd behavior, they basically make the No True Scotsman defense, that Ms Holmes would never do that. That is classic cult-like behavior.

I can't get my head around how they raised so much money with nothing but the most basic outline of an idea and not even an original one. Score one for political connections.

I smell something funny, but I don't think they have a test for that at Theranos.

Re:Also

[doru]

"Theranostics" is a contraction of "therapeutics" and "diagnostics". It's been a fashionable term in research over the last decade.

Scam company

[pesho]

I can't believe they are valued at ~10billion. They raise some telling red flags:

• 1. Board of directors with no expertise in the product their are making. Their board of directors is more suited to head a military invasion of a third world country than a biotech company (two former Secretaries of State, Kissinger and Shultz, a former Secretary of Defense and couple of retired generals).
• 2. They claim huge improvement in sensitivity (I am reading about two logs better sensitivity compared to traditional tests), but there is no information how this is achieved. Such improvement requires a radically different analytical approaches. Just miniaturizing the existing chemistries is not going to cut it.
• 3. Their IP is protected by trade secrets rather than patents. This one actually is quite absurd for a company that needs FDA approval. FDA wants to know not only that your product works but also how it works before issuing an approval. Peer review of the research is part of the process. There is no way for them to go through the approval process and keep a trade secret.
• 4. Virtually all the tests they perform are currently made by traditional tech. This may have changed, but initially they collected very small sample volumes. So they had to dilute their samples to do all the test, which increases the error and even the "classical" tests do not perform to specification when done by Theranos.

Who the hell invests in a company with non-existing tech and incompetent board???