Theranos

[Michael Scally MD]

Preface: I am a med tech and have managed a lab. This looks like bullshit. She's invented a marketing campaign for her lab. Her 'nano-tube' is the exact same thing that already exists, called a 'microtainer' made by BD. These get used in hospitals right now every day. Finger pricks also get done daily, usually on kids.

Finger pricks are undesirable samples for the following reasons:

1) Manual manipulation ('milking') the blood out of the finger results in higher chances of hemolysis - which can render the results of many tests invalid.

2) Finger pricks have a higher volume of interstitial fluid in the sample, possibly skewing the results

3) Finger pricks take longer

4) Finger pricks actually hurt more than a needle

5) Finger pricks tend to clot in the tube, a big no-no for CBCs. Modern chemistry and hematology analyzers only use microlitre amounts of serum per test. Every day labs do full chemistry panels on microtainers of blood - so I'm not sure why her system is better.

Now cost.

I'm sure that in the US testing costs a lot more than in Canada (dat profit) but in my lab the cost of reagents to do a standard panel (electolytes (Na, K, Cl), glucose, kidney function (BUN, Creatinine), liver function (ALP, AST, ALT, Total Bilirubin), automated CBC) would be on the order of $4-6 (and this is in a fairly low volume lab). If a stat sample is delivered to me I can have results back in 15-20 minutes on any modern chemistry analyzer for the above mentioned tests.

The reasons we take tubes with 'large' amounts of blood (I put 'large' in quotes because each tube holds about a teaspoon of blood, I could literally take 100s of them out before you'd feel the effects of blood loss) are:

1) It's a better sample - less recollections

2) We have extra in case there is a problem in analysis - less recollections

3) The Dr. can add on more tests if something comes back weird - less recollections

4) The Dr. can order immunoassays or esoteric testing that requires more volume - less recollections

Are you seeing a pattern here? The lab does NOT want to be recollecting. It's a waste of your time and a waste of our time. Why not take extra that you're not going to miss in the first place instead of having to come back a second time? Unless she has some breakthrough testing methodologies that require significantly less blood than is currently used. And I don't think some Stanford dropout working in her garage is better able to develop these tests than multibillion dollar diagnostics companies.

Trust me, if some company came along with an analyzer that required 10x less sample with no downsides, they would win the entire market and sell billions of dollars of reagents. Of course they'd be doing it if they could. She goes on about 'automated analysis' in her interview a bit, but labs are already HIGHLY automated. The trouble comes from shitty collections (fingerpricks) and shitty delivery times. She mentioned the problems of people not coming to get their bloodwork done because scared of needles - this is a problem, but its a pre-analytic problem that is not going to be solved with a new micro sampling technique. Bullshit.

https://np.reddit.com/r/technology/...invented_a_way_to_run_30_lab_tests_on/cif048f

 

[Michael Scally MD]

Bill Maris: Here's why Google Ventures didn't invest in Theranos
http://www.businessinsider.com/bill-maris-explains-why-gv-didnt-invest-in-theranos-2015-10

 

[Michael Scally MD]

Why I Believe My Theranos Blood Test Was Inaccurate And Useless
https://medium.com/@danmunro/why-i-...naccurate-and-useless-7854ed96f4ef#.4gclc5pd5

 

[Michael Scally MD]

FDA just posted two form 483 letters:
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm469395.pdf
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm469396.pdf

 

[Michael Scally MD]

At Theranos, many Strategies and Snags
At Theranos, Many Strategies and Snags

The night before a big meeting with a Swiss drug company in 2008, Theranos Inc. founder Elizabeth Holmes and a colleague sat in a Zurich hotel, sticking their fingers with a lancet.

They drew drops of their own blood to try the company’s testing machine, but the devices wouldn’t work, says someone familiar with the incident. Sometimes the results were obviously too high. Sometimes they were too low. Sometimes the machines spit out only an error message.

After two hours, the colleague called it quits, leaving Ms. Holmes still squeezing blood from her fingers to test it again.

Ever since she launched Theranos in 2003 when she was 19 years old and dropped out of Stanford University, Ms. Holmes has been driven by ambition that is big even by Silicon Valley standards. Instead of a smartphone app to hail a car or order food, she wants to revolutionize health care with a vast range of diagnostic tests run with a few drops of finger-pricked blood.

Now 31, Ms. Holmes has emphasized a variety of strategies—a hand-held device, tests for drugmakers, drugstore clinics—while trying to turn her dream into a business. She often has collided with technological problems, according to interviews with more than 20 former Theranos employees, company emails and complaints filed with federal regulators.

In Switzerland, she went ahead and pricked her finger in front of a group of Novartis AG executives at the meeting the next day, testing for a protein that measures inflammation, says the person familiar with the incident.

All three of her Theranos devices flickered with error messages, the person says. Ms. Holmes was unfazed, blamed a minor technical glitch and continued to pitch the vast potential of her technology.

Ms. Holmes and several current or former Theranos directors declined interview requests. A spokeswoman for Theranos, Brooke Buchanan, says Ms. Holmes recalls only one machine with an error message, because someone tripped over the cord. A second machine ran perfectly, and the third wasn’t used, the spokeswoman says. A Novartis spokeswoman wouldn’t comment.

Since a Wall Street Journal article in October, Ms. Holmes has defended the Palo Alto, Calif., company’s laboratory work and promised to publish data proving the accuracy of its more than 240 tests, ranging from pregnancy to diabetes.

She said earlier this month that customer volume was higher than ever. The company has said it performed millions of tests, with highly positive feedback.

For now, though, Theranos has stopped collecting tiny samples of blood from patients’ fingers for all but one of its tests while it waits for the Food and Drug Administration to review the company’s applications for wider use of the small proprietary vials called “nanotainers.” As a result, Theranos is using traditional lab machines for most of its tests.

…

 

[jJjburton]

I do not have the time to read this all but how is it done? I have not seen an article about this part of it.

 

[Michael Scally MD]

From Academy Award-winning director Alex Gibney comes a documentary about the rise and fall of Theranos, the one-time multibillion-dollar healthcare company founded by Elizabeth Holmes. Premieres March 18 on HBO.

The Inventor: Out for Blood in Silicon Valley
https://www.hbo.com/documentaries/the-inventor-out-for-blood-in-silicon-valley

Academy Award winner Alex Gibney (Enron: The Smartest Guys in the Room, HBO’s Emmy-winning Going Clear: Scientology and the Prison of Belief) directs a documentary investigating the rise and fall of Theranos, the one-time multibillion-dollar healthcare company founded by Elizabeth Holmes.

In 2004, Elizabeth Holmes dropped out of Stanford to start a company that was going to revolutionize healthcare. In 2014, Theranos was valued at $9 billion, making Holmes, who was touted as “the next Steve Jobs,” the youngest self-made female billionaire in the world. Just two years later, Theranos was cited as a “massive fraud” by the SEC, and its value was less than zero.

Drawing on extraordinary access to never-before-seen footage and testimony from key insiders, director Alex Gibney will tell a Silicon Valley tale that was too good to be true. With all the drama of a real-life heist film, the untitled documentary will examine how this could have happened and who is responsible, while exploring the psychology of deception.

 

[Thaistick]

The book was pretty good.

 

[grey]

With all the drama of a real-life heist film, the untitled documentary will examine how this could have happened and who is responsible, while exploring the psychology of deception.

From what I have seen, many folks at the investment decision level were fairly aware that this was all bullshit for quite some time. Looks like they just viewed it as paying the SJW danegeld. Cost of doing business today is throwing money at "diverse" projects like this that you know damn well are going to burn in.

 

[CensoredBoardsSuck]

SCIENCE OF US UPDATED MAR. 19, 2019
What Kind of Person Fakes Their Voice?
By Katie Heaney

Elizabeth Holmes. Photo: Gilbert Carrasquillo/Getty Images

There are many fascinating, upsetting details in the story of Elizabeth Holmes, but my favorite is her voice. Holmes, the ousted Theranos founder who was indicted last year on federal fraud charges for hawking an essentially imaginary product to multi-millionaire investors, pharmacies, and hospitals, speaks in a deep baritone that, as it turns out, is fake. Former co-workers of Holmes told The Dropout, a new podcast about Theranos’s downfall, that Holmes occasionally “fell out of character” and exposed her real, higher voice — particularly after drinking.

https://www.thecut.com/2019/03/why-did-elizabeth-holmes-use-a-fake-deep-voice.html?utm_medium=s1&utm_campaign=thecut&utm_source=tw