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Although Theranos was valued at $9 billion by some of its investors, which would have valued Holmes's stake at $4.6 billion, ''[[The Economist]]'' noted that startups of this nature can wind up being valued as a "fantasy" rather than based upon present reality.<ref>{{Cite news | title = The fable of the unicorn: A much-hyped medical startup is suddenly plagued with doubts | work = The Economist | date = October 31, 2015 | accessdate = October 31, 2015 | url=http://www.economist.com/news/business/21677192-fable-unicorn-theranos-much-hyped-medical-startup-plagued-doubts}}</ref> In 2016, ''[[Forbes]]'' revised the estimated net worth of the company to $800 million taking into account the $724 million of capital raised.<ref name="Forbes_nothing">{{Cite web|url=http://www.forbes.com/sites/matthewherper/2016/06/01/from-4-5-billion-to-nothing-forbes-revises-estimated-net-worth-of-theranos-founder-elizabeth-holmes/#6750a4fc2f29|title=From $4.5 Billion To Nothing: Forbes Revises Estimated Net Worth of Theranos Founder Elizabeth Holmes|last=Herper|first=Matthew|website=Forbes|access-date=June 1, 2016}}</ref>
Although Theranos was valued at $9 billion by some of its investors, which would have valued Holmes's stake at $4.6 billion, ''[[The Economist]]'' noted that startups of this nature can wind up being valued as a "fantasy" rather than based upon present reality.<ref>{{Cite news | title = The fable of the unicorn: A much-hyped medical startup is suddenly plagued with doubts | work = The Economist | date = October 31, 2015 | accessdate = October 31, 2015 | url=http://www.economist.com/news/business/21677192-fable-unicorn-theranos-much-hyped-medical-startup-plagued-doubts}}</ref> In 2016, ''[[Forbes]]'' revised the estimated net worth of the company to $800 million taking into account the $724 million of capital raised.<ref name="Forbes_nothing">{{Cite web|url=http://www.forbes.com/sites/matthewherper/2016/06/01/from-4-5-billion-to-nothing-forbes-revises-estimated-net-worth-of-theranos-founder-elizabeth-holmes/#6750a4fc2f29|title=From $4.5 Billion To Nothing: Forbes Revises Estimated Net Worth of Theranos Founder Elizabeth Holmes|last=Herper|first=Matthew|website=Forbes|access-date=June 1, 2016}}</ref>

On June 12, 2016, Walgreens announced it would no longer offer Theranos services at any of its stores and would sever its relationship with Theranos.<ref>{{cite news|title=Walgreens ends relationship with Theranos in latest blow for start-up|url=http://www.cnbc.com/2016/06/12/walgreen-ends-relationship-with-theranos-in-latest-blow-for-start-up-founder-elizabeth-holmes.html|publisher=CNBC}}</ref>


=== FDA ===
=== FDA ===
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On October 28, 2015, the [[Food and Drug Administration]] (FDA) also reported 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> The [[Arizona Department of Health Services]] reported issues in the company's other laboratory.<ref>{{cite web|url=http://www.usatoday.com/story/tech/nation-now/2015/11/30/arizona-inspectors-find-theranos-lab-issues/76588902/|title=Arizona inspectors find Theranos lab issues|date=30 November 2015|work=[[USA TODAY]]|accessdate=26 December 2015}}</ref> Several [[clinical pathologist]]s and other medical experts also expressed skepticism about Theranos's technology. A week later, the [[Food and Drug Administration]] (FDA) stated that the company's miniature blood containers were unapproved for any test other than the [[herpes]] test. Subsequently, Theranos was ordered to limit the use of its proprietary technology to only one of the 200 tests offered by the company.<ref name="NYT_James_2015" >{{cite web|url=http://www.nytimes.com/2015/10/30/business/the-narrative-frays-for-theranos-and-elizabeth-holmes.html|title=The Narrative Frays for Theranos and Elizabeth Holmes|date=October 30, 2015|work=The New York Times}}</ref><ref name="Dan_Fortune_2015">{{cite news |url=http://fortune.com/2015/10/15/theranos-unicorns/ |title=Theranos controversy has little to do with 'unicorns' |author=Dan Primack |date=October 15, 2015 |work=Fortune}}</ref>
On October 28, 2015, the [[Food and Drug Administration]] (FDA) also reported 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> The [[Arizona Department of Health Services]] reported issues in the company's other laboratory.<ref>{{cite web|url=http://www.usatoday.com/story/tech/nation-now/2015/11/30/arizona-inspectors-find-theranos-lab-issues/76588902/|title=Arizona inspectors find Theranos lab issues|date=30 November 2015|work=[[USA TODAY]]|accessdate=26 December 2015}}</ref> Several [[clinical pathologist]]s and other medical experts also expressed skepticism about Theranos's technology. A week later, the [[Food and Drug Administration]] (FDA) stated that the company's miniature blood containers were unapproved for any test other than the [[herpes]] test. Subsequently, Theranos was ordered to limit the use of its proprietary technology to only one of the 200 tests offered by the company.<ref name="NYT_James_2015" >{{cite web|url=http://www.nytimes.com/2015/10/30/business/the-narrative-frays-for-theranos-and-elizabeth-holmes.html|title=The Narrative Frays for Theranos and Elizabeth Holmes|date=October 30, 2015|work=The New York Times}}</ref><ref name="Dan_Fortune_2015">{{cite news |url=http://fortune.com/2015/10/15/theranos-unicorns/ |title=Theranos controversy has little to do with 'unicorns' |author=Dan Primack |date=October 15, 2015 |work=Fortune}}</ref>


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]] suspended 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 reported it had voluntarily suspended use of its flagship micro or low volume blood testing technique except for [[Herpes simplex|Herpes]] virus testing.<ref>{{Cite news | title = Theranos suspends micro blood tests to allow FDA review | work = AZ Central| date = October 25, 2015 | accessdate = 2015-10-26 | url=http://www.azcentral.com/news/arizona/investigations/2015/10/25/theranos-suspends-micro-blood-tests-allow-fda-review/74355082/}}</ref>
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> Additionally, after an FDA inspection, Theranos reported it had voluntarily suspended use of its flagship micro or low volume blood testing technique except for [[Herpes simplex|Herpes]] virus testing.<ref>{{Cite news | title = Theranos suspends micro blood tests to allow FDA review | work = AZ Central| date = October 25, 2015 | accessdate = 2015-10-26 | url=http://www.azcentral.com/news/arizona/investigations/2015/10/25/theranos-suspends-micro-blood-tests-allow-fda-review/74355082/}}</ref>


Subsequent articles have called into question previous statements by Theranos 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 that the government has noted significant concerns.<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> On August 31, 2016, Theranos withdrew its Zika virus test due to a finding by federal inspectors of a lack of essential safeguards during the testing process.<ref>{{cite news|title=Troubled Theranos hits another wall as Zika test withdrawn|url=https://www.washingtonpost.com/news/wonk/wp/2016/08/31/theranos-zika-test-withdrawn-after-regulators-flag-problems/|publisher=Washington Post|accessdate=31 August 2016}}</ref>
Subsequent articles have called into question previous statements by Theranos 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 that the government has noted significant concerns.<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> On August 31, 2016, Theranos withdrew its Zika virus test due to a finding by federal inspectors of a lack of essential safeguards during the testing process.<ref>{{cite news|title=Troubled Theranos hits another wall as Zika test withdrawn|url=https://www.washingtonpost.com/news/wonk/wp/2016/08/31/theranos-zika-test-withdrawn-after-regulators-flag-problems/|publisher=Washington Post|accessdate=31 August 2016}}</ref>

Revision as of 14:38, 23 October 2016

Theranos
Company typePrivate
IndustryHealth care
Founded2003; 21 years ago (2003)
FounderElizabeth Holmes
Headquarters
Palo Alto, California
,
United States
ProductsBlood tests
ServicesMedical tests
Websitewww.theranos.com

Theranos is an American privately held consumer health-technology company based in Palo Alto, California.[1] It is under criminal investigation by federal prosecutors and the Securities and Exchange Commission.[2]

Theranos developed a blood-testing device named Edison. The company said the device uses a few drops of blood obtained via a finger-stick, rather than vials of blood obtained via traditional venipuncture,[3] utilizing microfluidics technology.[4] By the summer of 2014, its founders had raised over $400 million from investors, valuing the company at $9 billion.[5][6]

In October 2015, controversy surrounding the company's blood testing process arose after a report in The Wall Street Journal raised concerns about the accuracy of its Edison device. An independent U.S. government review by the Centers for Medicare and Medicaid Services (CMS) reported inaccurate testing results and multiple deficiencies in sample handling during a recent inspection.

In June 1, 2016, Forbes revised its estimate of the company's net worth to $800 million.[7][8]

On July 7, 2016, Theranos announced that it had received notice from the Centers for Medicare & Medicaid Services (CMS) regarding the revocation of its CLIA certificate. Sanctions include a prohibition of the owners and operators from owning or operating a lab for two years and a civil monetary penalty.[9][10]

On October 5, 2016, Theranos announced that it would close its laboratory operations, shutter its wellness centers and lay off around 40 percent of its work force, while henceforth focusing on an initiative to create miniature medical testing machines.[11]

History

While at Stanford University, Elizabeth Holmes created a wearable patch to adjust the dosage of drug delivery and notify doctors wirelessly of variables in patient's blood.[12] She started developing lab-on-a-chip technology for blood tests and the idea for a company that would make testing cheaper, more convenient and accessible to consumers.[13] Holmes used the education trust from her parents for Stanford to found the company that would later be called Theranos, which is a combination of the words "therapy" and "diagnosis".[14][15]

In 2004, Theranos was headquartered out of a rented basement located near a strip mall by the Stanford campus.[16] By December 2004, Theranos had more than $6 million from investors with an estimated value of $30 million.[17] The company had about $45 million total fundraising after Series B and Series C funding in 2006.[18] Theranos raised an additional $45 million in 2010 and had an estimated value of $1 billion.[17][19]

The company moved to the former headquarters of Facebook in June 2012.[20] During its first 10 years of operation, Theranos was in stealth mode, similar to other Silicon Valley startups, which received criticism from the media and scientific community.[21] The company had significant news coverage starting in September 2013 after profiles in the San Francisco Business Times and Wall Street Journal.[13] By 2014, Theranos had raised more than $400 million with an estimated value of $9 billion.[22] In July 2015, the Food and Drug Administration approved the use of the company's fingerstick blood testing device for the herpes simplex virus (HSV-1) outside a clinical laboratory setting.[23][24] Theranos was awarded the 2015 Bioscience Company of the Year by AzBio.[25]

On October 5, 2016, Theranos announced that it was closing its laboratories and Walgreen's testing Centers and would instead focus on selling its miniLab blood testing device. [26][27][28]

Partnerships

In September 2013, Theranos partnered with Walgreens to offer in-store blood tests at more than 40 locations. Walgreens announced plans to expand the "wellness centers" across the United States.[29] The company's blood tests were used on drug trial patients of GlaxoSmithKline and Pfizer. Each company stated that there were no ongoing active projects with Theranos in October 2015.[30][31]

Cleveland Clinic announced a partnership with Theranos to test its technology in order to decrease the cost of lab tests.[32] Theranos became the lab-work provider for Pennsylvania insurers, AmeriHealth Caritas and Capital BlueCross, in July 2015.[33][34] Walgreens suspended its plans to add Theranos' testing services in its stores, and later removed Theranos' testing from all existing locations.[35][36]

Technology

During its first decade of operation, the company developed devices to automate and miniaturize blood tests using microscopic blood volumes. Theranos was best known for its "nanotainer" fingerstick, which draws a microliter sample of blood from the capillaries in a patient's hand.[37][38][39] Theranos claimed to have data verifying the accuracy and reliability of its tests that would be published.[40]

Its technology has been criticized for not being scientifically peer reviewed.[41][42] In February 2016, Theranos announced that it would permit the Cleveland Clinic to complete a validation study of its technology.[43] The Journal of Clinical Investigation found that the company's blood test results were "much more in line with the others than they are out of line" in March 2016.[44] In May 2016, Theranos announced that it had voided two years of results from its Edison device.[45] The company announced that about 1 percent of test results had been voided or corrected from its proprietary machines in June 2016.[46] While the company was expected to present data about its Edison technology to the American Association for Clinical Chemistry in August 2016,[47] it instead introduced a new robotic, capillary blood testing unit named miniLab.[48][49] The company did not address any questions or present any data related to the previous test results or the Edison device.

In August Theranos announced, and then later withdrew its request, for emergency clearance of a new Zika-virus blood test. The Wall Street Journal reported that according to unnamed sources, federal regulators had found that the company didn’t follow proper patient safeguards in a study for the test. Theranos’s vice president of regulatory, quality and clinical affairs Dave Wurtz stated: “We hope that our decision to withdraw the Zika submission voluntarily is further evidence of our commitment to engage positively with the agency.” [50]

Corporate affairs

Location

Theranos is headquartered in Palo Alto, California. It has laboratories in Newark, California and Scottsdale, Arizona.[51]

Management

Since its foundation in 2003, Holmes has been the company's chief executive officer. She recruited Channing Robertson, a chemical-engineering professor at Stanford, to be a technical advisor and the company's first board member during its early years. Sunny Balwani, a software engineer Holmes had met during high school, joined the company as its President and chief operating officer in 2009.[52] In July 2011, Holmes was introduced to former Secretary of State George Shultz, who joined the Theranos board of directors that same month.[53] Over the next three years, Shultz helped to introduce almost all the outside directors on the "all-star board," which included William Perry (former Secretary of Defense), Henry Kissinger (former Secretary of State), Sam Nunn (former U.S. Senator), Bill Frist (former U.S. Senator and heart-transplant surgeon), Gary Roughead (Admiral, USN, retired), James Mattis (General, USMC), Richard Kovacevich (former Wells Fargo Chairman and CEO) and Riley Bechtel (chairman of the board and former CEO at Bechtel Group).[53][54][55] The board was criticized for consisting "mainly of directors with diplomatic or military backgrounds."[13]

In April 2016, Theranos announced its medical advisory board which included past presidents or board members of the American Association for Clinical Chemistry.[56] Members were invited to review the company's proprietary technologies and advise on the integration into clinical practice.[56] The board included past presidents or board members of the American Association for Clinical Chemistry such as Susan A. Evans, William Foege, former director U.S. Centers for Disease Control and Prevention, David Helfet, director of the Orthopedic Trauma Service at the Hospital for Special Surgery and professors, Ann M. Gronowski, Larry J. Kricka, Jack Ladenson, Andy O. Miller and Steven Spitalnik.[57][58]

Balwani left his position as President and COO in May 2016. At that time, the company announced its new board members, Fabrizio Bonanni, Richard Kovacevich and William Foege, who would help to publicly introduce its technologies.[59] The following people joined Theranos as directors: Fabrizio Bonanni, former executive vice president of Amgen; Richard Kovacevich; and William Foege, former director of the Centers for Disease Control and Prevention.[60][61]

As of May 2016, the Theranos board of directors are:[62]

Controversies

On October 16, 2015, The Wall Street Journal, quoting many unnamed current and former employees, reported that Theranos's flagship Edison testing device might provide inaccurate results.[63] 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 (CMS).[63] Moreover, the bulk of the blood tests being performed by Theranos were reported to be conducted on traditional machines of competitors' companies, such as Siemens, rather than its own Edison machines.[42] Theranos attacked the Journal, but did not refute any of the allegations.[64]

Wired asserted that the company may have succumbed to Silicon Valley pressures of trying to "spin hype into startup gold" and promising more than they could deliver.[42] Theranos has claimed to have partnerships with GlaxoSmithKline and Pfizer, which both companies have denied.[31] Theranos also claimed the successful venture capital firm Draper Fisher Jurvetson 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.[65]

Although Theranos was valued at $9 billion by some of its investors, which would have valued Holmes's stake at $4.6 billion, The Economist noted that startups of this nature can wind up being valued as a "fantasy" rather than based upon present reality.[66] In 2016, Forbes revised the estimated net worth of the company to $800 million taking into account the $724 million of capital raised.[67]

FDA

On October 28, 2015, the Food and Drug Administration (FDA) also reported 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.[68] The Arizona Department of Health Services reported issues in the company's other laboratory.[69] Several clinical pathologists and other medical experts also expressed skepticism about Theranos's technology. A week later, the Food and Drug Administration (FDA) stated that the company's miniature blood containers were unapproved for any test other than the herpes test. Subsequently, Theranos was ordered to limit the use of its proprietary technology to only one of the 200 tests offered by the company.[70][71]

Theranos asserted that the reports were “factually and scientifically erroneous and grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents.”[72] Additionally, after an FDA inspection, Theranos reported it had voluntarily suspended use of its flagship micro or low volume blood testing technique except for Herpes virus testing.[73]

Subsequent articles have called into question previous statements by Theranos regarding the nature and source of its income.[31] 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.[74] On August 31, 2016, Theranos withdrew its Zika virus test due to a finding by federal inspectors of a lack of essential safeguards during the testing process.[75]

Centers for Medicare and Medicaid Services Certification

A report from the Centers for Medicare and Medicaid Services (CMS) released in 2016 detailed a number of deficiencies with Theranos procedures and testing results.[76] The inspection report indicates that 29% of the quality control checks performed on the Edison devices produced results outside an acceptable range.[77] In addition, federal inspectors also cited Theranos for "doing tests with unqualified personnel, for long delays in notifying patients of flawed test results and for storing blood samples at the wrong temperatures."[77]

On January 25, 2016, Centers for Medicare and Medicaid Services (CMS) sent a strongly-worded letter to Theranos following an inspection of the company's Newark, California laboratory, conducted in November 2015. "[I]t was determined that the deficient practices of the laboratory pose immediate jeopardy to patient health and safety," the letter noted.[78] CMS gave Theranos a deadline of 10 business days to prove that the laboratory was complying with hematology-related and other lab requirements. Three days later, Walgreens, which had partnered with Theranos to provide its blood testing services in stores, ceased all testing at a Palo Alto location, and ordered the company to process all of its other tests from Walgreens locations at its Arizona laboratory instead of the California lab.[79]

On July 7, 2016, Theranos announced that it had received notice from the CMS regarding the revocation of its CLIA certificate. Sanctions include a prohibition of the owners and operators from owning or operating a lab for two years, suspension of approval to receive Medicare and Medicaid payments, and a civil monetary penalty. Theranos' CEO Elizabeth Holmes responded in a statement: “We accept full responsibility for the issues at our laboratory in Newark, California, and have already worked to undertake comprehensive remedial actions. Those actions include shutting down and subsequently rebuilding the Newark lab from the ground up, rebuilding quality systems, adding highly experienced leadership, personnel and experts, and implementing enhanced quality and training procedures. While we are disappointed by CMS’ decision, we take these matters very seriously and are committed to fully resolving all outstanding issues with CMS and to demonstrating our dedication to the highest standards of quality and compliance.”[80]

In a later statement on its website replying to the CMS on July 8, 2016 Theranos announced it was discontinuing testing at its Newark location while attempting to resolve issues identified.[81] The company further stated “The clinical lab is just one of Theranos’ many opportunities to provide access to high-integrity, affordable and actionable health care information, and the company will continue to carry out its mission under the leadership of its founder and CEO, Elizabeth Holmes”.

On August 25, 2016, Theranos announced its plan to appeal the decision by regulators to revoke its license to operate a lab in California, among other penalties, because of unsafe practices. [82] On August 31, 2016, Theranos withdrew its Zika virus test due to a finding by federal inspectors of a lack of essential safeguards during the testing process.[83] On October 5, 2016, Theranos announced that it would close its laboratory operations, shutter its wellness centers and lay off around 40 percent of its work force, while henceforth focusing on an initiative to create miniature medical testing machines.[84][85]

Board of directors appointment of David Boies

Famed litigator David Boies was hired by Theranos after it failed a federal laboratory inspection.[86] The company’s general counsel is a former partner at Boies Schiller and Theranos had hired Boies in the past.[86] Theranos attracted controversy however, by also granting Boies a seat on the board of directors.[86] While the 2013 adopted high-vote stock structure gives Holmes total control of the company, business ethics insiders, reporting to the New York Times, argued that, while it has been done before, having Boies serve both on the board and as the company’s attorney would be difficult as he would have to represent both the Company (as lawyer) and the Investors (as a Director), and that this could in some circumstances result in making a choice between the two.[86]

U.S. military

On December 2, 2015, The Washington Post reported that 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. After retiring, Mattis joined the board of directors of Theranos.[87]

U.S. House of Representatives Committee Investigation

It was reported on July 1, 2016, that a U.S. House of Representatives committee investigation was being undertaken into Theranos' past practices. The Committee on Energy and Commerce requested information on what Theranos was doing to correct its testing inaccuracies and adherence to federal guidelines. In the letter sent to founder Elizabeth Holmes, a response was requested by July 14.[88] Theranos said in a statement that it looked forward to responding to the inquiry with an explanation of its improvements, including “new operational leadership, best practices in our laboratories, continuing and constructive engagement with our regulators and ongoing communications with physicians and our patients.”[89]

Litigation

In 2007, Theranos filed suit in Santa Clara, California, accusing former employees of breaching company secrecy.[13] 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.[90] Another case, in Washington, D.C. against McDermott Will & Emery itself, was dismissed in August 2013.[91][92]

Theranos is currently under criminal investigation by federal prosecutors and the Securities and Exchange Commission.[2]

Theranos is facing class-action complaints alleging misrepresentation of its testing services.[93]

On August 25, 2016, the company said it plans to appeal the decision by regulators to revoke its license to operate a lab in California, among other penalties, because of unsafe practices. [94]

A suit accusing Theranos of securities fraud was filed in October, 2016 by Partner Fund Management, which invested $96.1 million in the company in February 2014. The suit demands return of investment and damages. The company released a statement asserting "The suit is without merit, the assertions are baseless, and the plaintiff is engaging in revisionist history."[95]

See also

References

  1. ^ "Theranos". Manta.com.
  2. ^ a b Stross, Randall (27 April 2016). "Don't Blame Silicon Valley for Theranos". The New York Times. Retrieved 1 June 2016.
  3. ^ Rago, Joseph (2013-09-08). "Elizabeth Holmes: The Breakthrough of Instant Diagnosis". Wall Street Journal. Retrieved 2013-09-16.
  4. ^ Scott, Cameron (8 November 2013). "Small, fast and cheap, Theranos is the poster child of med tech — and it's in Walgreen's". Singularity Hub. Retrieved 9 March 2014.
  5. ^ Parloff, Roger (2014-06-12). "This CEO is out for blood". Fortune. Retrieved 2016-04-17.
  6. ^ Johnson, Carolyn Y. (2015-10-15). "The wildly hyped $9 billion blood test company that no one really understands". The Washington Post. ISSN 0190-8286. Retrieved 2015-10-29.
  7. ^ Herper, Matthew (2016-06-01). "From $4.5 Billion To Nothing: Forbes Revises Estimated Net Worth Of Theranos Founder Elizabeth Holmes". Forbes. Retrieved 2016-07-17.
  8. ^ Staley, Oliver (2016-06-01). "Forbes just cut its estimate of Theranos CEO Elizabeth Holmes's net worth from $4.5 billion to zero". Quartz. Retrieved 2016-07-09.
  9. ^ "Theranos Receives Notice of Sanctions from the Centers for Medicare & Medicaid Services". Theranos. 2016-07-07. Retrieved 2016-07-09.
  10. ^ Carreyrou, John; Siconolfi, Michael; Weaver, Christopher (2016-07-08). "Theranos Dealt Sharp Blow as Elizabeth Holmes Is Banned From Operating Labs". Wall Street Journal. ISSN 0099-9660. Retrieved 2016-07-09.
  11. ^ "Theranos to Close Labs and Lay Off 340 Workers". New York Times. Retrieved 5 October 2016.
  12. ^ Weisul, Kimberly (October 2015). "How Playing the Long Game Made Elizabeth Holmes a Billionaire". Inc. (magazine). Retrieved 3 September 2016.
  13. ^ a b c d Leuty, Ron (30 August 2013). "Theranos: The biggest biotech you've never heard of". San Francisco Business Times. Retrieved 9 March 2014.
  14. ^ Roper, Caitlin (18 February 2014). "This Woman Invented a Way to Run 30 Lab Tests on Only One Drop of Blood". Wired. Retrieved 27 September 2016.
  15. ^ Bolt, Beth (14 November 2014). "Bringing Painless Blood Testing to the Pharmacy". Pharmacy Times. Retrieved 27 September 2016.
  16. ^ Crow, David (8 April 2016). "Blood Simple". Financial Times. Retrieved 27 September 2016.
  17. ^ a b Carreyrou, John (27 December 2015). "At Theranos, Many Strategies and Snags". The Wall Street Journal. Retrieved 28 December 2015.
  18. ^ Leuty, Ron (29 June 2015). "Theranos: Testing times lie ahead for secretive blood-testing firm". American City Business Journals. Retrieved 27 September 2016.
  19. ^ Klein, Julie (2010-07-08). "Theranos raises $45M to help patients track drug reactions". VentureBeat. Retrieved 2013-09-16.
  20. ^ Segall, Eli (29 June 2012). "Theranos growing close to home in Palo Alto". Silicon Valley Business Journal. Retrieved 27 September 2016.
  21. ^ Grossman, Lev (5 May 2016). "The Fall Of Theranos And The Future Of Science In Silicon Valley". TIME (magazine). Retrieved 27 September 2016.
  22. ^ Loria, Kevin (29 September 2014). "This Woman's Revolutionary Idea Made Her A Billionaire — And Could Change Medicine". Business Insider. Retrieved 27 September 2016.
  23. ^ Parloff, Roger (2 July 2015). "Disruptive diagnostics firm Theranos gets boost from FDA". Fortune Magazine. Retrieved 16 July 2015.
  24. ^ Quinn, Michelle (16 July 2015). "Theranos gets another FDA approval for its blood test". Silicon Beat. Retrieved 27 September 2016.
  25. ^ "AZBio Awards 2015". AzBio.org. 2015. Retrieved 27 September 2016.
  26. ^ Post, Washington. "Theranos will close labs and Walgreens testing sites, laying off hundreds". chicagotribune.com. Retrieved 6 October 2016.
  27. ^ Mole, Beth (5 October 2016). "Theranos throws in the towel on clinical labs, officially pivots to devices". Ars Technica. Retrieved 6 October 2016.
  28. ^ Holmes, Elizabeth. "An Open Letter from Elizabeth Holmes". Theranos. Theranos. Retrieved 6 October 2016.
  29. ^ Moon, Mariella (18 November 2014). "Walgreens to offer affordable and needle-free blood tests in more stores (updated)". Business Insider. Retrieved 4 September 2016.
  30. ^ "Young blood". The Economist. 27 June 2015. Retrieved 4 September 2016.
  31. ^ a b c Duhaime-Ross, Arielle (2015-10-26). "Theranos didn't work with the huge drug company it supposedly made money from, drug company says". The Verge. Retrieved 2015-10-29.
  32. ^ "Theranos, Cleveland Clinic CEO's on innovation partnership". Fox Business. 9 March 2015. Retrieved 4 September 2016.
  33. ^ George, John (16 July 2016). "Philadelphia health insurer to make lab testing easier for Medicaid members". Philadelphia Business Journal. Retrieved 4 September 2016.
  34. ^ Chen, Caroline; Tracer, Zachary (8 July 2015). "Fingerprick Lab Test Startup Theranos Strikes Insurance Deal". Bloomberg. Retrieved 4 September 2016.
  35. ^ "Walgreens Terminates Relationship with Theranos; Will Be Closing Operations at All 40 Theranos Wellness Centers in Arizona". Business Wire. Retrieved 13 June 2016.
  36. ^ http://www.businessinsider.com/timeline-of-theranos-controversy-2016-10
  37. ^ Rago, Joseph (8 September 2013). "Elizabeth Holmes: The Breakthrough of Instant Diagnosis". Wall Street Journal. Retrieved 25 July 2016.
  38. ^ Nguyen, Tuan C. "How To Run 30 Health Tests On a Single Drop of Blood". Smithsonian Magazine. Smithsonian. Retrieved 31 October 2015.
  39. ^ Loria, Kevin (16 October 2015). "Here's what we know about how Theranos' 'revolutionary' technology works". Tech Insider. Retrieved 25 July 2016. {{cite web}}: Italic or bold markup not allowed in: |work= (help)
  40. ^ "Theranos Chief Yields to Calls for Proof of Blood Test's Reliability". The New York Times. 27 October 2015. Retrieved 26 December 2015.
  41. ^ Stewart, James B. "The Narrative Frays for Theranos and Elizabeth Holmes". The New York Times. The New York Times Company. Retrieved 31 October 2015.
  42. ^ a b c Lapowsky, Issie (2015-10-15). "Theranos' Scandal Exposes the Problem With Tech's Hype Cycle". Wired Magazine. Retrieved 2015-11-15.
  43. ^ "Theranos Has Still Not Begun a Promised Validation Study". Fortune. Retrieved 2016-02-02.
  44. ^ Loria, Kevin (28 March 2016). "A top medical institution ran a secret study on Theranos — here's what they found". Tech Insider. Retrieved 25 July 2016.
  45. ^ Carreyrou, John (2016-05-19). "Theranos Voids Two Years of Edison Blood-Test Results". Wall Street Journal. ISSN 0099-9660. Retrieved 2016-05-21.
  46. ^ Caroline Chen; Rebecca Spalding (June 3, 2016). "Theranos Says Only 1% of Results Affected; Some Doubt Tests". Bloomberg.com. Retrieved June 29, 2016.
  47. ^ Abelson, Reed (1 June 2016). "Elizabeth Holmes, Founder of Theranos, Falls From Highest Perch Off Forbes List". The New York Times. Retrieved 25 July 2016.
  48. ^ Langreth, Robert; Chen, Caroline (1 August 2016). "Expecting Data From Theranos, Lab Experts Get New Product". Bloomberg L.P. Retrieved 1 August 2016.
  49. ^ Herper, Matthew (1 August 2016). "Theranos Presents Data On New Blood Test Machine, Remains Mum On Previous Technology". Forbes. Retrieved 1 August 2016.
  50. ^ Carreyrou, John; Weaver, Christopher (30 August 2016). "Theranos Halts New Zika Test After FDA Inspection". Retrieved 6 October 2016 – via Wall Street Journal.
  51. ^ Abelson, Reed; Creswell, Julie (19 December 2015). "Theranos Founder Faces a Test of Technology, and Reputation". The New York Times. Retrieved 2 July 2016.
  52. ^ Auletta, Ken (15 December 2014). "Blood, Simpler". The New Yorker. Retrieved 31 May 2016.
  53. ^ a b Parloff, Roger (12 June 2014). "A singular board at Theranos". Fortune. Retrieved 11 May 2016.
  54. ^ Leuty, Ron (2 August 2013). "Theranos adds Kovacevich to all-star board". San Francisco Business Times. Retrieved 9 March 2014.
  55. ^ Leuty, Ron (29 July 2013). "Quiet Theranos adds former Wells chief Kovacevich, 'Mad Dog' Mattis to power-packed board". San Francisco Business Times. Retrieved 9 March 2014.
  56. ^ a b Parloff, Roger (7 April 2016). "Theranos Adds Startlingly Well-Qualified Medical Board". Fortune. Retrieved 14 April 2016.
  57. ^ Ramsey, Lydia (7 April 2016). "Theranos just made a crucial move that could help its reputation". Business Insider. Retrieved 9 September 2016.
  58. ^ Weisul, Kimberly (7 April 2016). "Heavy Hitters Join Theranos Advisory Board". Inc. Retrieved 9 September 2016.
  59. ^ Masunaga, Samantha. "Theranos shuffles leadership; president retires". latimes.com. Los Angeles Times. Retrieved 9 September 2016.
  60. ^ Carreyrou, John. "Theranos Executive Sunny Balwani to Depart Amid Regulatory Probes". wsj.com. Retrieved 12 May 2016.
  61. ^ della Cava, Marco. "Theranos COO departs as embattled startup adds to board". usatoday.com. USA Today. Retrieved 12 May 2016. Theranos also is adding former Amgen executive Fabrizio Bonanni to its board.
  62. ^ Abelson, Reed (11 May 2016). "Embattled Blood Lab Theranos Makes a Bid to Regain Confidence". The New York Times. Retrieved 17 May 2016.
  63. ^ a b Carreyrou, John. "Hot Startup Theranos Has Struggled With Its Blood-Test Technology". Wall Street Journal. ISSN 0099-9660. Retrieved 2015-10-29.
  64. ^ Dawn Chmielewski. "Theranos Attacks Wall Street Journal (Again) in a Rebuttal You'll Need a Medical Degree to Understand". Re/code. Retrieved 26 December 2015.
  65. ^ Caroline Chen (19 October 2015). "Early Theranos Investor Stands by Blood Testing Startup". Bloomberg.com. Retrieved 26 December 2015.
  66. ^ "The fable of the unicorn: A much-hyped medical startup is suddenly plagued with doubts". The Economist. October 31, 2015. Retrieved October 31, 2015.
  67. ^ Herper, Matthew. "From $4.5 Billion To Nothing: Forbes Revises Estimated Net Worth of Theranos Founder Elizabeth Holmes". Forbes. Retrieved June 1, 2016.
  68. ^ Carreyrou, John. "FDA Inspectors Call Theranos Blood Vial 'Uncleared Medical Device'". Wall Street Journal. ISSN 0099-9660. Retrieved 2015-10-29.
  69. ^ "Arizona inspectors find Theranos lab issues". USA TODAY. 30 November 2015. Retrieved 26 December 2015.
  70. ^ "The Narrative Frays for Theranos and Elizabeth Holmes". The New York Times. October 30, 2015.
  71. ^ Dan Primack (October 15, 2015). "Theranos controversy has little to do with 'unicorns'". Fortune.
  72. ^ "Report Claims Theranos Struggling With Blood Test Tech". Fortune. Retrieved 2015-10-16.
  73. ^ "Theranos suspends micro blood tests to allow FDA review". AZ Central. October 25, 2015. Retrieved 2015-10-26.
  74. ^ "The FDA's notes from its visit to Theranos' labs don't look good". Business Insider. 27 October 2015. Retrieved 2015-10-27.
  75. ^ "Troubled Theranos hits another wall as Zika test withdrawn". Washington Post. Retrieved 31 August 2016.
  76. ^ "Theranos Scandal Widens on Scathing Report". Fox Business. April 4, 2016.
  77. ^ a b "Theranos Devices Often Failed Accuracy Requirements". Wall Street Journal. March 31, 2016. {{cite news}}: Italic or bold markup not allowed in: |publisher= (help)
  78. ^ "Regulators warn testing startup Theranos over lab conditions". Associated Press. January 27, 2016. Retrieved February 2, 2016.
  79. ^ "Theranos Sounded Too Good to Be True—and It Is". Daily Beast. February 2, 2016. Retrieved February 2, 2016.
  80. ^ "Theranos Receives Notice of Sanctions from the Centers for Medicare & Medicaid Services". theranos.com. 7 July 2016. Retrieved 6 October 2016.
  81. ^ "Theranos Statement on CMS Findings". Retrieved 13 July 2016.
  82. ^ "Theranos to Appeal Regulatory Sanctions" Wall Street Journal,Retrieved 26 August 2016.
  83. ^ "Troubled Theranos hits another wall as Zika test withdrawn". Washington Post. Retrieved 31 August 2016.
  84. ^ "Theranos to Close Labs and Lay Off 340 Workers". New York Times. Retrieved 5 October 2016.
  85. ^ "An Open Letter From Elizabeth Holmes". Theranos Newsroom. 5 October 2016. Retrieved 6 October 2016.
  86. ^ a b c d Solomon, Steven Davidoff (2 February 2016). "David Boies's Dual Roles at Theranos Set Up Conflict". The New York Times' Dealbook. Retrieved 10 February 2016.
  87. ^ Carolyn Y. Johnson (2 December 2015). "E-mails reveal concerns about Theranos's FDA compliance date back years". Washington Post. Retrieved 26 December 2015.
  88. ^ Lagasse, Jeff (2016-07-01). "Theranos founder Elizabeth Holmes asked by Congressional committee to detail company's compliance efforts". Healthcare Finance News. Retrieved 2016-07-02.
  89. ^ Tracer, Zachary. "Theranos Queried on Blood Test Failures by House Democrats". Retrieved 5 July 2016.
  90. ^ Beth Winegarner (March 17, 2014). "Patent Theft Trial Over McDermott Docs Settles". Law360.
  91. ^ Overly, Jeff (5 August 2013). "McDermott Ducks Health IT Client's IP Theft Suit". Law360. LexisNexis. Retrieved 9 March 2014.
  92. ^ Tillman, Zoe (5 August 2013). "Malpractice Suit Against McDermott Dismissed". ALM. pp. The Blog of Legal Times. Retrieved 9 March 2014.
  93. ^ Rappleye, Emily (2016-06-03). "Third Theranos lawsuit brings Walgreens into the mix". Becker's Hospital Review. Retrieved 2016-07-02.
  94. ^ "Theranos to Appeal Regulatory Sanctions" Wall Street Journal,Retrieved 26 August 2016.
  95. ^ O'Brien, Sara Ashley (October 11, 2016). "Theranos investor: We want our $96 million back". CNN. Retrieved October 11, 2016.
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