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Theranos

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Vorlage:Infobox company

Theranos is an American privately-held health-technology and medical-laboratory-services company based in Palo Alto, California.[1]

Theranos claimed to have developed a blood-testing device named Edison that uses a few drops of blood obtained via a finger-stick, rather than vials of blood obtained via traditional venipuncture,[2] utilizing microfluidics technology.[3] Its founders raised over $400 million from investors, valuing the company at $9 billion.[4] In 2015, controversy surrounding the company arose after a report in The Wall Street Journal raised concerns about the accuracy of its Edison device.

History

Theranos was founded in 2003 by Elizabeth Holmes with the goal of streamlining and standardizing blood tests by creating a hand-held device.[5]

Holmes claims to have founded a software company and worked on a protein microarray for the detection of SARS in Singapore,[6] and left Stanford University at age 19 while a sophomore majoring in chemical engineering, to start Theranos.[7] Holmes' Stanford chemical engineering professor Channing Robertson had encouraged her in the endeavor, and joined the board of directors.[6] By the end of 2004, Theranos had raised at least $6.9 million, the first $1 million an investment by Tim Draper, a founder of Draper Fisher Jurvetson.[5]

The company had raised $16 million in two rounds of initial fundraising,[8] and $28.5 million in a third round in 2006.[9] In 2010, Theranos raised an additional $45 million from a single unnamed investor,[8] bringing its total funding to more than $70 million. Investors included ATA Ventures, Tako Ventures, Continental Properties Inc.,[10] and Larry Ellison, former CEO of Oracle.[6] With this funding, the company was valued at more than $1 billion.[5]

In February 2015, a Journal of the AMA editorial noted that information about such technology had appeared in the mainstream press including The Wall Street Journal, Business Insider, San Francisco Business Times, Fortune, Forbes, Medscape, and Silicon Valley Business Journal, but not in the peer-reviewed biomedical literature.[11]

Controversies

On October 16, 2015, The Wall Street Journal, quoting many unnamed current and former employees, revealed that Theranos's flagship Edison testing device might provide very inaccurate results.[12] The alleged discrepancies in Theranos' proficiency testing and reporting to regulators led to a formal complaint filed with the New York State Department of Health that was forwarded to the Centers of Medicare and Medicaid Services.[12] Moreover, the bulk of the blood tests being performed by Theranos were revealed to be conducted on traditional machines of competitors' companies, such as Siemens, rather than its own Edison machines.[13] Wired asserted that the company may have been succumbing to Silicon Valley pressures of trying to "spin hype into startup gold" and promising more than they could deliver.[13] Theranos attacked the Wall Street Journal, but did not refute any of the allegations.[14]

Theranos has also claimed to have partnerships with GlaxoSmithKline and Pfizer, which both GlaxoSmithKline and Pfizer have denied.[15] The company also claimed successful venture capital firm Draper Fisher Jurveston had invested in them, but company principal Steve Jurvetson clarified that it had provided the company's first $500,000 seed investment and nothing more.[16]

FDA

On October 28, 2015, the Food and Drug Administration also revealed major shortcomings in the company's practices and ordered Theranos to stop using its Edison device, which it had neither tested for accuracy nor approved, contrary to the company's previous claims.[17] Theranos was ordered to limit its use of Edison to one of the 200 tests it offers. The Arizona Department of Health Services has found issues in the company's other laboratory.[18]

Theranos asserted that the reports were “factually and scientifically erroneous and grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents.”[19] Subsequently, a key metric of Theranos valuation was notably called into question when Walgreens placed on hold further expansion of Theranos Wellness Centers.[20] Additionally, after an FDA inspection Theranos reports it has voluntarily suspended use of its flagship micro or low volume blood testing technique except for Herpes virus testing.[21]

Subsequent articles have called into question the credibility of statements Theranos has previously made regarding the nature and source of its income.[15] Though Theranos has often claimed to have FDA approval for its laboratory tests, FDA inspection reports from 2014 and 2015 suggest that the government has noted significant concerns.[22]

U.S. military

On December 2, The Washington Post revealed the exploration of a partnership with the US military had led to issues being found with the Edison device and a request that the FDA investigate. This request was denied by United States Marine Corps General James Mattis after Holmes's intervention. Mattis later joined the Board of Directors of Theranos.[23]

Corporate partners

After the revelations of October 2015, Theranos's partner Walgreens suspended their plans to rollout Theranos's testing services in their stores,[24] and it was revealed that Safeway had already cancelled a $350 million agreement to use Theranos's testing technology amid doubts about its accuracy.[25] The Cleveland Clinic hospital, recently announced as a Theranos partner, distanced itself from Theranos's technology and denied they had verified its accuracy.[26] Customers have reported writing to Theranos querying inaccurate results, receiving no response.[27]

On October 27, 2015, Theranos claimed to have data verifying the accuracy of its Edison testing device and announced it would publish it.[28]

CMS certification

On January 27, 2016, don't remove this - the Centers for Medicare and Medicaid Services said that Theranos's Newark, California location posed "immediate jeopardy to patient safety," and required a response in 10 days, or it would pull its certification of the lab.[29]

Edison device

Very little information is publicly known of the process Theranos uses to test blood in its proprietary Theranos Edison[13] blood testing device.[30][31] Theranos' device design uses a fingerstick to draw a microlitre sample of blood into a disposable cartridge, which is loaded into the device's "reader" for analysis; results are sent wirelessly from the reader to a secure database, from where they go online to the patient or patient's physician.[32] In July 2015, the Food and Drug Administration provided limited approval for Theranos' Edison device for use in a herpes simplex virus (HSV-1) blood test, which tests for disease using a finger-prick's worth of blood, but did not verify its accuracy.[33] Although this FDA waiver applies only to this one test, Theranos announced it is pursuing FDA clearances on more than 120 other diagnostic exams it performs using similar hardware and software.

The technology used in the Theranos device has not been scientifically peer reviewed,[34] but in response to the Wall Street Journal's revelations, on 27 October 2015 Theranos promised to publish its testing results data for scientific peer review.[5]

Governance

While other aspects of its operations remain secretive,[35] Theranos corporate governance has been the subject of various press disclosures and subsequent news reports.

In July 2013, the composition of the Theranos board of directors changed markedly, with departure of Channing Robertson (emeritus professor, chemical engineering, Stanford University),[36] experienced pharma and biotech executive Robert B. Shapiro (former chairman/CEO of the Pharmacia, Monsanto, and G.D. Searle group of companies), and financier Pete Thomas (principal, ATA Ventures).[6][35] Remaining from the original board were Theranos President and COO Ramesh "Sunny" Balwani and former Secretary of State George Shultz; added to the new board were Riley P. Bechtel (chairman of the board at Bechtel Group), Richard Kovacevich (former Wells Fargo Chairman and CEO), Sam Nunn and Bill Frist (former U.S. Senators), Henry Kissinger (former Secretary of State), William Perry (former Secretary of Defense), William Foege (epidemiologist, former director U.S. CDC), James Mattis (General, USMC, retired) and Gary Roughead (Admiral, USN, retired),[35][37][38] several of whom are members of Stanford's Hoover Institution,[39] with medical doctors Frist and Foege, and lawyer/executive Bechtel being added most recently (in 2014).[40][41][42]

A consequence of these 2013 changes, noted Ron Leuty of the San Francisco Business Times, was that "Theranos’ board… consists mainly of directors with diplomatic or military backgrounds."[35] While two physicians have subsequently been named to the board, and published reference has been made to a "deep medical advisory group,"[42] as of January 2016, no scientific or medical advisory board information appears in the company's public information.

Litigation

In 2007, Theranos filed suit in Santa Clara, California, accusing former employees of breaching company secrecy.[6] In 2011 the company filed suit against Fuisz Pharma LLC, accusing them of stealing Theranos' patent files from McDermott Will & Emery. The suit was settled in 2014.[43] Another case, in Washington, D.C. against McDermott Will & Emery itself, was dismissed in August 2013.[44][45]

See also

References

Vorlage:Reflist

  1. ↑ Theranos. Manta.com;
  2. ↑ Joseph Rago: Elizabeth Holmes: The Breakthrough of Instant Diagnosis In: Wall Street Journal, 8. September 2013. Abgerufen am 16. September 2013 
  3. ↑ Cameron Scott: Small, fast and cheap, Theranos is the poster child of med tech — and it's in Walgreen's In: Singularity Hub, 8 November 2013. Abgerufen im 9 March 2014 
  4. ↑ Carolyn Y. Johnson: The wildly hyped $9 billion blood test company that no one really understands In: The Washington Post, 15. Oktober 2015. Abgerufen am 29. Oktober 2015 
  5. ↑ a b c d John Carreyrou: At Theranos, Many Strategies and Snags, 27 December 2015. Abgerufen im 28 December 2015 
  6. ↑ a b c d e Ron Leuty: Theranos: The biggest biotech you’ve never heard of In: San Francisco Business Times, 30 August 2013. Abgerufen im 9 March 2014 
  7. ↑ Developing the Future of Home Healthcare (podcast). The DFJ Entrepreneurial Thought Leaders Seminar;
  8. ↑ a b Luke Timmerman: Theranos Raises $45M For Personalized Medicine In: Xconomy, 8 July 2010. Abgerufen im 9 March 2014 
  9. ↑ Theranos raises $28.5M for device tracking effects of drugs on patients In: VentureBeat, 7 December 2006. Abgerufen im 9 March 2014 
  10. ↑ Julie Klein: Theranos raises $45M to help patients track drug reactions In: VentureBeat, 8. Juli 2010. Abgerufen am 16. September 2013 
  11. ↑ John P. A. Ioannidis: Stealth Research: Is Biomedical Innovation Happening Outside the Peer-Reviewed Literature? In: JAMA. 313. Jahrgang, Nr. 7, 17. Februar 2015, S. 663–664., doi:10.1001/jama.2014.17662.
  12. ↑ a b John Carreyrou: Hot Startup Theranos Has Struggled With Its Blood-Test Technology In: Wall Street Journal. Abgerufen am 29. Oktober 2015 
  13. ↑ a b c Issie Lapowsky: Theranos’ Scandal Exposes the Problem With Tech’s Hype Cycle. In: Wired Magazine. 15. Oktober 2015, abgerufen am 15. November 2015.
  14. ↑ Dawn Chmielewski: Theranos Attacks Wall Street Journal (Again) in a Rebuttal You’ll Need a Medical Degree to Understand. In: Re/code. Abgerufen am 26. Dezember 2015.
  15. ↑ a b Arielle Duhaime-Ross: Theranos didn’t work with the huge drug company it supposedly made money from, drug company says. In: The Verge. 26. Oktober 2015, abgerufen am 29. Oktober 2015.
  16. ↑ Caroline Chen: Early Theranos Investor Stands by Blood Testing Startup. In: Bloomberg.com. 19. Oktober 2015, abgerufen am 26. Dezember 2015.
  17. ↑ John Carreyrou: FDA Inspectors Call Theranos Blood Vial ‘Uncleared Medical Device’ In: Wall Street Journal. Abgerufen am 29. Oktober 2015 
  18. ↑ Arizona inspectors find Theranos lab issues. In: USA TODAY. 30. November 2015, abgerufen am 26. Dezember 2015.
  19. ↑ Report Claims Theranos Struggling With Blood Test Tech. In: Fortune. Abgerufen am 16. Oktober 2015.
  20. ↑ Walgreens halts expansion of Theranos centers In: Fortune Magazine, 24 October 2015. Abgerufen am 25. Oktober 2015 
  21. ↑ Theranos suspends micro blood tests to allow FDA review In: AZ Centeral, October 25, 2015. Abgerufen am 26. Oktober 2015 
  22. ↑ The FDA's notes from its visit to Theranos' labs don't look good In: Business Insider, 27 October 2015. Abgerufen am 27. Oktober 2015 
  23. ↑ Carolyn Y. Johnson: E-mails reveal concerns about Theranos’s FDA compliance date back years. In: Washington Post. 2. Dezember 2015, abgerufen am 26. Dezember 2015.
  24. ↑ Quinn: Time for Theranos and Elizabeth Holmes to open up. Abgerufen am 26. Dezember 2015.
  25. ↑ Daniel Roberts: A Theranos Deal With Safeway Stores May be Falling Apart. In: Fortune. 11. November 2015, abgerufen am 26. Dezember 2015.
  26. ↑ http://www.cnbc.com/2015/10/30/well-work-to-verify-theranos-technology-cleveland-clinic-ceo.html
  27. ↑ Theranos Trouble: A First Person Account. In: Monday Note. Abgerufen am 26. Dezember 2015.
  28. ↑ Theranos Chief Yields to Calls for Proof of Blood Test’s Reliability. In: The New York Times. 27. Oktober 2015, abgerufen am 26. Dezember 2015.
  29. ↑ US government says Theranos lab poses 'immediate jeopardy to patient safety'. In: The Verge. Abgerufen am 27. Januar 2016.
  30. ↑ Tuan C. Nguyen: How To Run 30 Health Tests On a Single Drop of Blood. In: Smithsonian Magazine. Smithsonian, abgerufen am 31. Oktober 2015.
  31. ↑ Caolyn Y. Johnson: Theranos’ ‘groundbreaking’ approach isn’t breaking much new ground. In: Washington Post. Washington Post, abgerufen am 31. Oktober 2015.
  32. ↑ Jasmine D. Adkins: The Lifesaver In: Inc., 22. Juni 2006. Abgerufen am 16. September 2013 
  33. ↑ Roger Parloff: Disruptive diagnostics firm Theranos gets boost from FDA, Fortune Magazine, 2 July 2015. Abgerufen im 16 July 2015 
  34. ↑ James B. Stewart: The Narrative Frays for Theranos and Elizabeth Holmes. In: The New York Times. The New York Times Company, abgerufen am 31. Oktober 2015.
  35. ↑ a b c d Ron Leuty, 2013, "Theranos: The biggest biotech you’ve never heard of" San Francisco Business Times (online), Aug 30, 2013, accessed 28 January 2014. Quote: "Theranos continues to move stealthily. Requests to speak with Holmes or other executives, board members and the company’s financiers were consistently rebuffed, and the company declined to provide any answers to written questions."
  36. ↑ Stanford Engineering, 2014, "Channing Robertson Timeline," see [1], accessed 28 January 2014
  37. ↑ Ron Leuty: Theranos adds Kovacevich to all-star board In: San Francisco Business Times, 2 August 2013. Abgerufen im 9 March 2014 
  38. ↑ Ron Leuty: Quiet Theranos adds former Wells chief Kovacevich, 'Mad Dog' Mattis to power-packed board In: San Francisco Business Times, 29 July 2013. Abgerufen im 9 March 2014 
  39. ↑ Ron Leuty: Secretive Theranos emerging (partly) from shadows In: San Francisco Business Times, 9 September 2013. Abgerufen im 9 March 2014 
  40. ↑ Anon., 2015, "Company Overview of Theranos, Inc.: …Key Developments," in BloombergBusiness (online), see [2], accessed 28 January 2014
  41. ↑ Anon., 2014, "Theranos Appoints Riley P. Bechtel to its Board of Directors," BusinessWire (online), March 25, 2014, see [3], accessed 28 January 2015.
  42. ↑ a b Marco della Cava, 2014, "Change Agents: Elizabeth Holmes wants your blood, USA Today (online), July 26, 2014, see [4], accessed 28 January 2014
  43. ↑ Beth Winegarner: Patent Theft Trial Over McDermott Docs Settles. Law360, 17. März 2014;.
  44. ↑ Jeff Overly: McDermott Ducks Health IT Client's IP Theft Suit In: Law360, LexisNexis, 5 August 2013. Abgerufen im 9 March 2014 
  45. ↑ Zoe Tillman: Malpractice Suit Against McDermott Dismissed. ALM, 5. August 2013, S. The Blog of Legal Times, abgerufen am 9. März 2014.
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