Theranos

2015-12-08T02:20:15Z

199.112.128.15: typo

{{Infobox company
| name = Theranos
| logo =
| type = [[Privately held company|Private]]
| foundation = {{start date and age|2003}}
| founder = [[Elizabeth Holmes (businessperson)|Elizabeth Holmes]]
| location_city = [[Palo Alto, California]]
| location_country = [[United States]]
| key_people = Elizabeth Holmes, Ramesh "Sunny" Balwani
| industry = [[Health care]]
| products = [[Blood test]]s
| services = [[Medical test]]s
| owner =
| num_employees =
| homepage = http://www.theranos.com
| footnotes =
}}

'''Theranos''' is an American [[privately-held]] [[health-technology]] and [[medical-laboratory]]-services company based in [[Palo Alto, California]].<ref>{{Cite web|url= http://www.manta.com/c/mmd07qm/theranos |title=Theranos |publisher=Manta.com }}</ref> Theranos has claimed to have developed a [[blood-testing]] device named Edison that uses a few drops of blood obtained via a [[finger stick|finger-stick]] rather than vials of blood obtained via traditional [[venipuncture]],<ref name="online">{{Cite news|url=http://online.wsj.com/news/articles/SB10001424127887324123004579055003869574012/|title= Elizabeth Holmes: The Breakthrough of Instant Diagnosis|accessdate=2013-09-16 | work= [[Wall Street Journal]] | first=Joseph|last=Rago|date=2013-09-08}}</ref> utilizing [[microfluidics]] technology.<ref>{{cite news|url=http://singularityhub.com/2013/11/18/small-fast-and-cheap-theranos-is-the-poster-child-of-med-tech-and-its-in-walgreens/|title=Small, fast and cheap, Theranos is the poster child of med tech — and it's in Walgreen's|last=Scott|first=Cameron|date=8 November 2013|work=Singularity Hub|accessdate=9 March 2014}}</ref> Its founders have raised over $400 million from investors, valuing the company at $9 billion, without their testing device ever being subject to peer-reviewed study.<ref>{{Cite news|title = The wildly hyped $9 billion blood test company that no one really understands|url = http://www.washingtonpost.com/news/wonkblog/wp/2015/10/15/the-wildly-hyped-9-billion-blood-test-company-that-no-one-really-understands/|newspaper = The Washington Post|date = 2015-10-15|access-date = 2015-10-29|issn = 0190-8286|first = Carolyn Y.|last = Johnson}}</ref>

On 16 October 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.<ref>{{Cite news|title = Hot Startup Theranos Has Struggled With Its Blood-Test Technology|url = http://www.wsj.com/articles/theranos-has-struggled-with-blood-tests-1444881901|newspaper = Wall Street Journal|access-date = 2015-10-29|issn = 0099-9660|first = John|last = Carreyrou}}</ref> Theranos attacked the ''Wall Street Journal'', but did not refute any of the allegations.<ref>http://recode.net/2015/10/22/theranos-attacks-wall-street-journal-again-in-a-rebuttal-youll-need-a-medical-degree-to-understand/</ref> On 28 October 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.<ref>{{Cite news|title = FDA Inspectors Call Theranos Blood Vial ‘Uncleared Medical Device’|url = http://www.wsj.com/articles/fda-inspectors-call-theranos-blood-vial-uncleared-medical-device-1445967607|newspaper = Wall Street Journal|access-date = 2015-10-29|issn = 0099-9660|first = John|last = Carreyrou}}</ref> 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.<ref>http://www.usatoday.com/story/tech/nation-now/2015/11/30/arizona-inspectors-find-theranos-lab-issues/76588902/</ref>

On 2nd December, [[The Washington Post]] revealed the exploration of a partnership with the [[United States Armed Forces|US military]] had lead 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.<ref>https://www.washingtonpost.com/news/wonk/wp/2015/12/02/internal-emails-reveal-concerns-about-theranoss-fda-compliance-date-back-years/?tid=pm_business_pop_b</ref>

Theranos has also claimed to have partnerships with [[GlaxoSmithKline]] and [[Pfizer]], which both GlaxoSmithKline and Pfizer have denied.<ref name="Duhaime-Ross">{{Cite web|title = Theranos didn’t work with the huge drug company it supposedly made money from, drug company says|last=Duhaime-Ross|first=Arielle|date=2015-10-26|url = http://www.theverge.com/2015/10/26/9618390/Theranos-glaxosmithkline-denies-partnership-pfizer-blood-test|website = The Verge|accessdate = 2015-10-29}}</ref> 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.<ref>http://www.bloomberg.com/news/articles/2015-10-19/early-theranos-investor-remains-supportive-even-without-answers-ifydlf03</ref>

After the revelations of October 2015, Theranos's partner [[Walgreens]] suspended their plans to rollout Theranos's testing services in their stores,<ref>http://www.marinij.com/arts-and-entertainment/20151019/quinn-time-for-theranos-and-elizabeth-holmes-to-open-up/3</ref> and it was revealed that [[Safeway]] had already cancelled a $350 million agreement to use Theranos's testing technology amid doubts about its accuracy.<ref>http://fortune.com/2015/11/11/theranos-safeway-deal/</ref> [[The Cleveland Clinic]] hospital, recently announced as a Theranos partner, distanced itself from Theranos's technology and denied they had verified its accuracy.<ref>http://www.cnbc.com/2015/10/30/well-work-to-verify-theranos-technology-cleveland-clinic-ceo.html</ref> Customers have reported writing to Theranos querying inaccurate results, receiving no response.<ref>http://www.mondaynote.com/2015/10/18/theranos-trouble-a-first-person-account/</ref>

On 27 October 2015, Theranos claimed to have data verifying the accuracy of its Edison testing device and announced it would publish it.<ref>http://www.nytimes.com/2015/10/27/business/chief-of-theranos-pledges-to-prove-blood-tests-reliability.html</ref> As of 27 November 2015, it has not done so.

==History==
Theranos was founded in 2003 by [[Elizabeth Holmes (businessperson)|Elizabeth Holmes]] with the goal of streamlining and standardizing blood tests by creating a [[hand-held device]].

Holmes claims to have founded a software company and worked on a [[protein microarray]] for the detection of [[SARS]] in Singapore,<ref name=never>{{cite news|url=http://www.bizjournals.com/sanfrancisco/print-edition/2013/08/30/theranos-the-biggest-biotech-youve.html|title=Theranos: The biggest biotech you’ve never heard of|last=Leuty|first=Ron|date=30 August 2013|work=San Francisco Business Times|accessdate=9 March 2014}}</ref> and left [[Stanford University]] at age 19 while a sophomore majoring in [[chemical engineering]], to start Theranos.<ref name="podbay">{{Cite web|url= http://podbay.fm/show/80867514/e/1236153600|title=Developing the Future of Home Healthcare (podcast) |publisher=The DFJ Entrepreneurial Thought Leaders Seminar }}</ref> Holmes' Stanford chemical engineering professor Channing Robertson had encouraged her in the endeavor, and joined the [[board of directors]].<ref name=never/> The company had raised $16 million in two rounds of initial fundraising,<ref name=xconomy/> and $28.5 million in a third round in 2006.<ref>{{cite news|url=http://venturebeat.com/2006/12/07/theranos-raises-285m-for-device-tracking-effects-of-drugs-on-patients/|title=Theranos raises $28.5M for device tracking effects of drugs on patients|date=7 December 2006|work=VentureBeat|accessdate=9 March 2014}}</ref> In 2010, Theranos raised an additional $45 million from a single unnamed investor,<ref name=xconomy>{{cite news|url=http://www.xconomy.com/san-francisco/2010/07/08/theranos-raises-45m-for-personalized-medicine/|title=Theranos Raises $45M For Personalized Medicine|last=Timmerman|first=Luke|date=8 July 2010|work=Xconomy|accessdate=9 March 2014}}</ref> bringing its total funding to more than $70 million. Investors included ATA Ventures, Tako Ventures, Continental Properties Inc.,<ref>{{Cite news|url=http://venturebeat.com/2010/07/08/theranos-raises-45m-to-help-patients-track-drug-reactions/|title=Theranos raises $45M to help patients track drug reactions|accessdate=2013-09-16 | work= [[VentureBeat]] | first=Julie|last=Klein|date=2010-07-08}}</ref> and [[Larry Ellison]], former CEO of [[Oracle Corporation|Oracle]].<ref name=never/>

In February 2015, a [[JAMA (journal)|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.<ref>{{cite journal|author1=John P. A. Ioannidis|title=Stealth Research: Is Biomedical Innovation Happening Outside the Peer-Reviewed Literature?|journal=JAMA|date=February 17, 2015|volume=313|issue=7|pages=663–664.|doi=10.1001/jama.2014.17662|accessdate=19 February 2015}}</ref>

In October 2015, a ''Wall Street Journal'' investigative report cited former Theranos employees in asserting that lab work processed on its own Edison machines showed discrepancies on a number of specific blood tests when tested against traditional equipment.<ref name=":0">{{Cite news|title = Hot Startup Theranos Has Struggled With Its Blood-Test Technology|url = http://www.wsj.com/articles/theranos-has-struggled-with-blood-tests-1444881901|newspaper = Wall Street Journal|access-date = 2015-10-15|issn = 0099-9660|first = John|last = Carreyrou}}</ref> 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.<ref name=":0" /> 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.<ref name="Issie" /> ''[[Wired (magazine)|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.<ref name="Issie" />

Theranos asserted that the reports were “factually and scientifically erroneous and grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents.”<ref>{{Cite web|title = Report Claims Theranos Struggling With Blood Test Tech|url = http://fortune.com/2015/10/15/theranos-blood-tests-wsj/|website = Fortune|accessdate = 2015-10-16}}</ref> Subsequently, a key metric of Theranos valuation was notably called into question when Walgreens placed on hold further expansion of Theranos Wellness Centers.<ref>{{Cite news | title = Walgreens halts expansion of Theranos centers | work = Fortune Magazine | date = 24 October 2015 | accessdate = 2015-10-25 | url=http://fortune.com/2015/10/24/walgreens-theranos/}}</ref> 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.<ref>{{Cite news | title = Theranos suspends micro blood tests to allow FDA review | work = AZ Centeral| date = 25 October 2015 | accessdate = 2015-10-26 | url=http://www.azcentral.com/story/news/arizona/investigations/2015/10/25/theranos-suspends-micro-blood-tests-allow-fda-review/74355082/}}</ref>

Subsequent articles have called into question the credibility of statements Theranos has previously made regarding the nature and source of its income.<ref name="Duhaime-Ross" /> Though Theranos has often claimed to have FDA approval for its laboratory tests, FDA inspection reports from 2014 and 2015 suggest significant concerns the government has noted.<ref>{{Cite news | title = The FDA's notes from its visit to Theranos' labs don't look good | work = Business Insider | date = 27 October 2015 | accessdate = 2015-10-27 | url=http://www.businessinsider.com/fda-documents-on-theranos-2015-10}}</ref>

==Edison device==
Very little information is publicly known of the process Theranos uses to test blood in its proprietary Theranos Edison<ref name="Issie">{{cite web|last1=Lapowsky|first1=Issie|date=2015-10-15|title=Theranos’ Scandal Exposes the Problem With Tech’s Hype Cycle|url=http://www.wired.com/2015/10/theranos-scandal-exposes-the-problem-with-techs-hype-cycle/|website=Wired Magazine|accessdate=2015-11-15}}</ref> blood testing device.<ref>{{cite web|last1=Nguyen|first1=Tuan C.|title=How To Run 30 Health Tests On a Single Drop of Blood|url=http://www.smithsonianmag.com/innovation/how-to-run-30-health-tests-on-a-single-drop-of-blood-180949983|website=Smithsonian Magazine|publisher=Smithsonian|accessdate=31 October 2015}}</ref><ref>{{cite web|last1=Johnson|first1=Caolyn Y.|title=Theranos’ ‘groundbreaking’ approach isn’t breaking much new ground|url=https://www.washingtonpost.com/news/wonkblog/wp/2015/10/30/theranos-groundbreaking-approach-isnt-breaking-much-new-ground/|website=Washington Post|publisher=Washington Post|accessdate=31 October 2015}}</ref> Theranos' device design uses a fingerstick to draw a microliter 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.<ref name="inc">{{Cite news|url=http://www.inc.com/30under30/holmes.html|title=The Lifesaver|accessdate=2013-09-16 | work= [[Inc. (magazine)|Inc.]] | first=Jasmine D.|last=Adkins|date=2006-06-22}}</ref> 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.<ref>{{cite news|last1=Parloff|first1=Roger|title=Disruptive diagnostics firm Theranos gets boost from FDA|url=http://fortune.com/2015/07/02/theranos-fda-approval/|accessdate=16 July 2015|publisher=Fortune Magazine|date=2 July 2015}}</ref> 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,<ref>{{cite web|last1=Stewart|first1=James B.|title=The Narrative Frays for Theranos and Elizabeth Holmes|url=http://www.nytimes.com/2015/10/30/business/the-narrative-frays-for-theranos-and-elizabeth-holmes.html|website=The New York Times|publisher=The New York Times Company|accessdate=31 October 2015}}</ref> 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. As of 26 November 2015, it has not done so.<ref>{{cite news|last1=Pollack|first1=Andrew|title=Theranos Chief Yields to Calls for Proof of Blood Test’s Reliability|url=http://www.nytimes.com/2015/10/27/business/chief-of-theranos-pledges-to-prove-blood-tests-reliability.htm|accessdate=31 October 2015|work=The New York Times|publisher=The New York Times Company|date=27 October 2015}}</ref>

==Governance==
While other aspects of its operations remain secretive,<ref name=LeutySFBTAug13/> 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),<ref>Stanford Engineering, 2014, "Channing Robertson Timeline," see [http://engineering.stanford.edu/channing-robertson-timeline], accessed 28 January 2014</ref> 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).<ref name=never/><ref name=LeutySFBTAug13>Ron Leuty, 2013, [https://www.bizjournals.com/sanfrancisco/print-edition/2013/08/30/theranos-the-biggest-biotech-youve.html?page=all "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."</ref> 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. [[Centers for Disease Control and Prevention|CDC]]), [[James Mattis]] (General, [[United States Marine Corps|USMC]], retired) and [[Gary Roughead]] (Admiral, [[United States Navy|USN]], retired),<ref name=LeutySFBTAug13/><ref>{{cite news|url=http://www.bizjournals.com/sanfrancisco/print-edition/2013/08/02/theranos-adds-kovacevich-to-all-star.html|title=Theranos adds Kovacevich to all-star board|last=Leuty|first=Ron|date=2 August 2013|work=San Francisco Business Times|accessdate=9 March 2014}}</ref><ref>{{cite news|url=http://www.bizjournals.com/sanfrancisco/blog/biotech/2013/07/theranos-dick-kovacevich-james-mattis.html|title=Quiet Theranos adds former Wells chief Kovacevich, 'Mad Dog' Mattis to power-packed board|last=Leuty|first=Ron|date=29 July 2013|work=San Francisco Business Times|accessdate=9 March 2014}}</ref> several of whom are members of [[Stanford University|Stanford's]] [[Hoover Institution]],<ref name=emerging>{{cite news|url=http://www.bizjournals.com/sanfrancisco/blog/biotech/2013/09/theranos-elizabeth-holmes-walgreens.html|title=Secretive Theranos emerging (partly) from shadows|last=Leuty|first=Ron|date=9 September 2013|work=San Francisco Business Times|accessdate=9 March 2014}}</ref> with medical doctors Frist and Foege, and lawyer/executive Bechtel being added most lately (in 2014).<ref name=AnonBloomb15>Anon., 2015, "Company Overview of Theranos, Inc.: …Key Developments," in BloombergBusiness (online), see [http://host.businessweek.com/research/stocks/private/snapshot.asp?privcapId=20334531], accessed 28 January 2014</ref><ref>Anon., 2014, "Theranos Appoints Riley P. Bechtel to its Board of Directors," BusinessWire (online), March 25, 2014, see [https://www.businesswire.com/news/home/20140325005637/en/Theranos-Appoints-Riley-P.-Bechtel-Board-Directors#.VMkWilohzzI], accessed 28 January 2015.</ref><ref name = dellaCavaUSATJul14>Marco della Cava, 2014, "Change Agents: Elizabeth Holmes wants your blood, USA Today (online), July 26, 2014, see [https://www.usatoday.com/story/tech/2014/07/08/change-agents-elizabeth-holmes-theranos-blood-testing-revolution/12183437/], accessed 28 January 2014</ref>

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."<ref name=LeutySFBTAug13/> While two physicians have subsequently been named to the board, and published reference has been made to a "deep medical advisory group,"<ref name = dellaCavaUSATJul14/> as of January 2015, no scientific or medical advisory board information appears in the company's public information.

== Litigation ==
Since 2007, the company has filed suits against three former allies:
First, it filed suit [[Santa Clara County Superior Court|in Santa Clara]], California, accusing former employees of breaching company secrecy.<ref name=never/> It also filed suit, claiming intellectual property theft, against a former partner of the [[law firm]] [[McDermott Will & Emery]],{{vague|date=June 2015|reason= Be explicit abt whether MW&E was acting as ''their'' lawyers}} a case that was dismissed in June 2012. Another case, in Washington, D.C. and against the law firm itself, was dismissed in August 2013.<ref>{{cite news|url=http://www.law360.com/articles/462480/mcdermott-ducks-health-it-client-s-ip-theft-suit|title=McDermott Ducks Health IT Client's IP Theft Suit|last=Overly|first=Jeff|date=5 August 2013|work=Law360|publisher=LexisNexis|accessdate=9 March 2014}}</ref><ref>{{cite web|url=http://legaltimes.typepad.com/blt/2013/08/malpractice-suit-against-mcdermott-dismissed.html|title=Malpractice Suit Against McDermott Dismissed|last=Tillman|first=Zoe|date=5 August 2013|publisher=ALM|pages=The Blog of Legal Times|accessdate=9 March 2014}}</ref>

== See also ==
* [[Hematology]]
* [[Medical device]]

== References ==
{{reflist|2}}

== External links ==
* {{Official website|http://www.theranos.com/}}
* {{cite web|url=http://www.medscape.com/viewarticle/814233_1|title=Creative Disruption? She's 29 and Set to Reboot Lab Medicine|last=[[Eric Topol|Topol]]|first=Eric J.|date=18 November 2013|work=[[Medscape]]|accessdate=9 March 2014}}
* {{cite web|url=http://ecorner.stanford.edu/authorMaterialInfo.html?mid=2113|title=Audio Podcast: Developing the Future of Home Healthcare|last=Holmes|first=Elizabeth|date=4 March 2009|work=ecorner|publisher=Stanford Technology Ventures Program|accessdate=9 March 2014}}
* {{cite web|url=http://fora.tv/2013/11/06/one_tiny_drop_changes_everything|title=Theranos: The Breakthrough of Instant Diagnosis|work=WIRED Data <nowiki>|</nowiki> Life|publisher=fora.tv|accessdate=9 March 2014}} (video)
* {{cite web|url=http://codesaints.com/startup-stories/most-valuable-startups/|title=Theranos Becomes a Successful Startup Ventures|accessdate=1 March 2015}}

[[Category:Companies based in Palo Alto, California]]
[[Category:Medical equipment manufacturers]]
[[Category:Technology companies established in 2003]]
[[Category:Technology companies based in the San Francisco Bay Area]]
[[Category:2003 establishments in California]]

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Theranos