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The Food and Drug Administration received a formal inquiry to look at Theranos blood test devices by the Department of Defense in 2012 before the devices were commercially available and did not require FDA approval.<ref>{{cite web|url=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|title=E-mails reveal concerns about Theranos’s FDA compliance date back years|author=Carolyn Y. Johnson|date=2 December 2015|work=[[Washington Post]]|accessdate=26 December 2015}}</ref> FDA inspection reports from 2014 and 2015 stated that its containers for blood collection were "not validated under actual or simulated use conditions" and "were not reviewed and not approved by designated individual(s) prior to issuance."<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> After the inspection, Theranos announced that it would voluntarily suspended its tests apart from the FDA approved herpes simplex virus (HSV-1) test.<ref>{{cite web | url=http://www.techtimes.com/articles/98407/20151022/blood-testing-start-up-theranos-is-in-pause-period-says-ceo-elizabeth-holmes.htm | title=Blood-Testing Start-Up Theranos Is In 'Pause Period', Says CEO Elizabeth Holmes | publisher=Tech Times | date=22 October 2015 | accessdate=23 October 2016 | author=Derla, Katherine}}</ref>
The Food and Drug Administration received a formal inquiry to look at Theranos blood test devices by the Department of Defense in 2012 before the devices were commercially available and did not require FDA approval.<ref>{{cite web|url=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|title=E-mails reveal concerns about Theranos’s FDA compliance date back years|author=Carolyn Y. Johnson|date=2 December 2015|work=[[Washington Post]]|accessdate=26 December 2015}}</ref> FDA inspection reports from 2014 and 2015 stated that its containers for blood collection were "not validated under actual or simulated use conditions" and "were not reviewed and not approved by designated individual(s) prior to issuance."<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> After the inspection, Theranos announced that it would voluntarily suspended its tests apart from the FDA approved herpes simplex virus (HSV-1) test.<ref>{{cite web | url=http://www.techtimes.com/articles/98407/20151022/blood-testing-start-up-theranos-is-in-pause-period-says-ceo-elizabeth-holmes.htm | title=Blood-Testing Start-Up Theranos Is In 'Pause Period', Says CEO Elizabeth Holmes | publisher=Tech Times | date=22 October 2015 | accessdate=23 October 2016 | author=Derla, Katherine}}</ref>


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.<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 = 2015-10-29|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]] (CMS).<ref name=":0"/> 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.<ref name="Issie"/> Theranos attacked the ''Journal'', but did not refute any of the allegations.<ref>{{cite web|url=http://recode.net/2015/10/22/theranos-attacks-wall-street-journal-again-in-a-rebuttal-youll-need-a-medical-degree-to-understand/|title=Theranos Attacks Wall Street Journal (Again) in a Rebuttal You’ll Need a Medical Degree to Understand|author=Dawn Chmielewski|work=[[Re/code]]|accessdate=26 December 2015}}</ref>
In October 2015, ''The Wall Street Journal'' reported that Theranos was using traditional blood testing machines, such as [[Siemens]], to run its tests and that the company's Edison machines might provide inaccurate results.<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 = 2015-10-29|issn = 0099-9660|first = John|last = Carreyrou}}</ref> Theranos claimed that the allegations 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><ref>{{cite web|url=http://recode.net/2015/10/22/theranos-attacks-wall-street-journal-again-in-a-rebuttal-youll-need-a-medical-degree-to-understand/|title=Theranos Attacks Wall Street Journal (Again) in a Rebuttal You’ll Need a Medical Degree to Understand|author=Dawn Chmielewski|work=[[Re/code]]|accessdate=26 December 2015}}</ref>


=== Centers for Medicare and Medicaid Services Certification===
=== Centers for Medicare and Medicaid Services Certification===

Revision as of 15:46, 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]

In 2016, Forbes revised the estimated net worth of the company to $800 million taking into account the $724 million of capital raised.[26] 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. [27][28][29]

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.[30] 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.[31][32]

Cleveland Clinic announced a partnership with Theranos to test its technology in order to decrease the cost of lab tests.[33] Theranos became the lab-work provider for Pennsylvania insurers, AmeriHealth Caritas and Capital BlueCross, in July 2015.[34][35] Walgreens suspended its plans to add Theranos' testing services in its stores, and later removed Theranos' testing from all existing locations.[36][37]

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.[38][39][40] Theranos claimed to have data verifying the accuracy and reliability of its tests that would be published.[41]

Its technology has been criticized for not being scientifically peer reviewed.[42][43] In February 2016, Theranos announced that it would permit the Cleveland Clinic to complete a validation study of its technology.[44] 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.[45] In May 2016, Theranos announced that it had voided two years of results from its Edison device.[46] The company announced that about 1 percent of test results had been voided or corrected from its proprietary machines in June 2016.[47] While the company was expected to present data about its Edison technology to the American Association for Clinical Chemistry in August 2016,[48] it instead introduced a new robotic, capillary blood testing unit named miniLab.[49][50] 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.” [51]

Corporate affairs

Location

Theranos is headquartered in Palo Alto, California. It has laboratories in Newark, California and Scottsdale, Arizona.[52]

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.[53] In July 2011, Holmes was introduced to former Secretary of State George Shultz, who joined the Theranos board of directors that same month.[54] 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).[54][55][56] 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.[57] Members were invited to review the company's proprietary technologies and advise on the integration into clinical practice.[57] 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.[58][59]

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.[60] 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.[61][62]

As of May 2016, the Theranos board of directors are:[63]

Controversy

The Food and Drug Administration received a formal inquiry to look at Theranos blood test devices by the Department of Defense in 2012 before the devices were commercially available and did not require FDA approval.[64] FDA inspection reports from 2014 and 2015 stated that its containers for blood collection were "not validated under actual or simulated use conditions" and "were not reviewed and not approved by designated individual(s) prior to issuance."[65] After the inspection, Theranos announced that it would voluntarily suspended its tests apart from the FDA approved herpes simplex virus (HSV-1) test.[66]

In October 2015, The Wall Street Journal reported that Theranos was using traditional blood testing machines, such as Siemens, to run its tests and that the company's Edison machines might provide inaccurate results.[67] Theranos claimed that the allegations were "factually and scientifically erroneous and grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents."[68][69]

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.[70] The inspection report indicates that 29% of the quality control checks performed on the Edison devices produced results outside an acceptable range.[71] 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."[71]

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.[72] 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.[73]

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.”[74]

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.[75] 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. [76] 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.[77] 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.[78][79]

Board of directors appointment of David Boies

Famed litigator David Boies was hired by Theranos after it failed a federal laboratory inspection.[80] The company’s general counsel is a former partner at Boies Schiller and Theranos had hired Boies in the past.[80] Theranos attracted controversy however, by also granting Boies a seat on the board of directors.[80] 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.[80]

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.[81] 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.”[82]

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.[83] Another case, in Washington, D.C. against McDermott Will & Emery itself, was dismissed in August 2013.[84][85]

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.[86]

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. [87]

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."[88]

See also

References

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External links

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