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Beats me. Analysis of public information suggests their lobbying and business partnerships were far more successful than their science. Only one peer-reviewed pilot study published in an online-only journal (1). Total of 6 patients, one test, nothing to do with routine blood diagnostics. Slim pickings so we need to move on.

Much of the public record on Theranos’ science and business activities pertain to

  • Patents initiated with the late Ian Gibbons, a microfluidics expert, and continued with others.
  • Running tests for big pharma clinical trials but no data disclosed by either side, and even denied by the pharmas.
  • Successfully lobbying at least one state legislature to pass a bill favorable to its business model.
  • Partnerships with Safeways and Walgreens to open on-site blood collection centers, partnerships that either never materialized or are floundering.

Theranos Patents: Generic Process Patents on Blood Collection and Data Analysis

(2)

‘In 2005, Ms. Holmes hired Ian Gibbons, a British biochemist who had researched systems to handle and process tiny quantities of fluids. His collaboration with other Theranos scientists produced 23 patents, according to records filed with the U.S. Patent and Trademark Office. Ms. Holmes is listed as a co-inventor on 19 of the patents’

(3)

‘A search in the JUSTIA patent database using Theranos as a search term yielded 71 items retrieved as of January 5, 2015’

A Sep 2013, WSJ article even refers to a patent filed for a ‘a wearable diagnostic device that would attach to the body with silicon microneedles “about the size of a human hair”‘ (4).

(5)

‘In an interview for Fortune in 2014, Elizabeth Holmes described the Theranos approach as “lab-on-a-chip technology” based on microfluidics and, on searching the US Patent Office for “Theranos”, this term appears in nine of the 31 patents’

This means as of 2015, Theranos filed ~71 patents, 9 of which were approved. Most of these patent filings are on nothing revolutionary by any stretch of the imagination. Rather they are just generic pieces on blood collection processes and data analysis. It seems as though they sought to patent protect the entire process of routine blood collection, handling and processing by simply introducing a little tweak at the front end, i.e., starting with a finger-prick. An end run if ever there was one.

Theranos Running Tests For Big Pharma Clinical Trials: None of these big pharma partners have publicly concurred or shared any of this data

A prominent 2015 Inc profile of Theranos’ CEO, Elizabeth Holmes says she raised $6 million by 2005, spent the early years working on some kind of wearable patch and the next few years as an ‘outsourced pharma lab‘ (6) by ‘securing contracts with pharma companies to function as their testing facility‘ for clinical trials. Big pharmas namechecked by Holmes in such interviews include Pfizer and GlaxoSmithKline (7). These pharmas report their relationship rather differently (8),

‘Pfizer said its work with the company was limited and ended years ago. GlaxoSmithKline also said it had not conducted any work with Theranos in the last two years and that none of it had involved its clinical trials’

Holmes has publicly stated, ‘We have data that show you can get a perfect correlation between a finger stick and a venipuncture for every test that we run‘ (7). Where is this data? Not shared publicly as far as I can tell, not by Theranos nor by their alleged big pharma partners. Neither their proprietary technology.

David Crow and Adam Samson at the Financial Times write (9),

‘Theranos has not made its proprietary equipment available for testing by independent experts, citing a desire to stop its competitors copying its technology. Eleftherios Diamandis, head of clinical biochemistry at Toronto’s Mount Sinai Hospital, described this as “highly abnormal”‘

Why highly abnormal? ‘When someone brings out a new machine or technology, they usually seek a specialist to test it and to publish the data in a peer reviewed journal,” Dr Diamandis said. “If you have technology that is patentable then no one can copy it — I don’t think they want to expose it to the scrutiny of independent assessors‘ (9).

Successfully Lobbying A State Legislature To Pass A Bill Favorable To Its Business Model

First reports of Theranos’ lobbying efforts started appearing in the Arizona Republic around Feb 2015 (10), bearing fruit just a few months later in July 2015 when Arizona passed a bill co-authored by Holmes allowing patients to order blood tests without a prescription (11).

Theranos Partnerships With Safeway, US Grocery Chain, and Walgreens, US Drugstore Chain: Still-born and Unraveling, Respectively

Sometime in 2012-2013, the US grocery chain, Safeway apparently signed a deal with Theranos to be ‘the exclusive supermarket provider of Theranos tests‘  (12) but the deal soon floundered and petered out. According to this John Carreyrou WSJ report (12),

‘Safeway spent ~$350 million to build clinics in more than 800 of its supermarkets to offer blood tests by startup Theranos Inc. But the tests never began, the clinics are now used largely for flu shots and travel-related vaccines, and the two companies have been negotiating to officially dissolve their partnership, according to people familiar with the matter’.

In an initial phase of the project, Safeway had Theranos conduct blood testing at the headquarters clinic, current and former Safeway executives said.

Theranos often drew the same employee’s blood twice, first with blood from a finger prick and then the traditional method of a needle in the arm, according to one former Safeway executive. The former executive said he worried that Theranos’s finger-prick process was still a work in progress. “If the technology is fully developed, why would you need to do a venipuncture?” this person said, using the term for a traditional blood draw.
The concerns deepened when Theranos’s test results for several Safeway employees differed from the results the same employees got from other laboratories, according to the former executive. Another former Safeway executive confirmed those recollections.

One Safeway executive got a frighteningly high result from Theranos on a test to gauge his prostate-specific antigen, according to two former Safeway executives. They said the test suggested that the executive had prostate cancer. Retesting by another lab came back normal.

By early 2013, some stores in California had hired phlebotomists, or the technicians who specialize in drawing blood, according to the current and former Safeway executives.

But Theranos kept delaying the rollout of its blood-testing services, those people said.’

In 2013, Theranos rolled out its partnership with Walgreens, the Theranos Wellness Centers, ~56 blood collection sites in Arizona and California. Early 2016, we’ve come full circle and news reports suggest Walgreen’s looking for ways to wriggle out of its Theranos deal without paying penalty for breach of contract (13).

The latest Theranos setback suggests at least some of their lab staff aren’t competent to even run tests on regular arm vein blood samples run on conventional diagnostic machines. The latest WSJ John Carreyrou story on a federal inspection report says even with repeated quality control failures, they kept running and reporting a blood clot test, prothrombin time, on at least 81 patients over a 6-month period (14). These weren’t on their proprietary machines using proprietary tech but routine tests run on conventional machines made by Siemens AG. Perhaps nothing screams dysfunctional lab more than screwing up a routine lab test.

Bibliography

1. Chan, Steven M., et al. “Intensive serial biomarker profiling for the prediction of neutropenic Fever in patients with hematologic malignancies undergoing chemotherapy: a pilot study.” Hematology reports 6.2 (2014). http://www.ncbi.nlm.nih.gov/pmc/…

2. John Carreyrou, Oct 16, 2015. Hot Startup Theranos Has Struggled With Its Blood-Test Technology

3. Ioannidis, John PA. “Stealth research: is biomedical innovation happening outside the peer-reviewed literature?.” JAMA 313.7 (2015): 663-664. http://citeseerx.ist.psu.edu/vie…; Search Patents – Justia Patents Search

4. Joseph Rago, Wall Street Journal, Sep 8, 2013. Elizabeth Holmes: The Breakthrough of Instant Diagnosis

5. Plebani, Mario. “Evaluating and using innovative technologies: a lesson from Theranos?.” Clinical Chemistry and Laboratory Medicine (CCLM) 53.7 (2015): 961-962. http://www.degruyter.com/dg/view…

6. Kimberly Weisul, Wired, Inc, Sep 16, 2015. How Playing the Long Game Made Elizabeth Holmes a Billionaire

7. Ken Auletta, The New Yorker. Dec 15, 2014. Blood, Simpler – The New Yorker

8. Reed Abelson and Julie Creswell, The New York Times, Dec 19, 2015. Theranos Founder Faces a Test of Technology, and Reputation

9. David Crow and Adam Samson, The Financial Times, Oct 23, 2015. Theranos blood labs under fresh scrutiny on staffing and quality – FT.com

10. Tech company Theranos pushes consumer lab-testing bill. Ken Alltucker, The Arizona Republic, Feb 27, 2015. http://www.azcentral.com/story/n…

11. Marco della Cava, USA Today, July 2, 2015. Now no doctor’s note needed for blood test in Arizona

12. John Carreyrou, Nov 10, 2015. Safeway, Theranos Split After $350 Million Deal Fizzles  

13. David Crow, Financial Times, Feb 29, 2016. Walgreens looks to cut ties with Theranos – FT.com

14. John Carreyrou, Wall Street Journal, Mar 7, 2016. Theranos Ran Tests Despite Quality Problems

https://www.quora.com/What-has-Theranos-been-doing-for-ten-years-if-their-tech-doesnt-work/answer/Tirumalai-Kamala

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