Theranos

Theranos
Private
Industry Health care
Founded 2003 (2003)
Founder Elizabeth Holmes
Headquarters Palo Alto, California, United States
Key people
 Elizabeth Holmes,
Chairman/CEO
David Helfet,
Co-Chairman
Products Blood tests
Services Medical tests
Website www.theranos.com

Theranos is an American privately held health technology company based in Palo Alto, California. The company has been recognized for its fingerstick and microfluidics technology. It was founded in 2003 by Elizabeth Holmes at the age of 19.[1] By 2014, Theranos had raised more than $400 million in funding with an estimated value of $9 billion.[2][3]

In 2015, Theranos received negative news coverage due to concerns about the effectiveness of its technologies. The company's net worth is estimated to be $800 million as of June 2016.[4] In July 2016, Theranos received sanctions from the Centers for Medicare & Medicaid Services (CMS) including the revocation of its CLIA certificate and prohibition of the owners and operators from owning or operating a lab for two years.[5] Theranos announced that it would close its laboratory operations and wellness centers to work on miniature medical testing machines in October 2016.[6]

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.[7] 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.[8] 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".[9][10]

In 2004, Theranos was headquartered out of a rented basement located near a strip mall by the Stanford campus.[11] By December 2004, Theranos had more than $6 million from investors with an estimated value of $30 million.[12] The company had about $45 million total fundraising after Series B and Series C funding in 2006.[13] Theranos raised an additional $45 million in 2010 and had an estimated value of $1 billion.[12][14]

The company moved to the former headquarters of Facebook in June 2012.[15] 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.[16] The company had significant news coverage starting in September 2013 after profiles in the San Francisco Business Times and Wall Street Journal.[8] By 2014, Theranos had raised more than $400 million with an estimated value of $9 billion.[17] 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.[18][19] Theranos was awarded the 2015 Bioscience Company of the Year by AzBio.[20]

In 2016, Forbes revised the estimated net worth of the company to $800 million taking into account the $724 million of capital raised.[21]

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.[22] 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.[23][24] In November 2016, Walgreen Co. filed suit against Theranos in a federal court in Delaware, for breach of contract. They are seeking $140 million in damages.[25]

Cleveland Clinic announced a partnership with Theranos to test its technology in order to decrease the cost of lab tests.[26] Theranos became the lab-work provider for Pennsylvania insurers, AmeriHealth Caritas and Capital BlueCross, in July 2015.[27][28]

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.[29][30][31] Theranos claimed to have data verifying the accuracy and reliability of its tests that would be published.[32]

Its technology has been criticized for not being scientifically peer reviewed.[33][34] In February 2016, Theranos announced that it would permit the Cleveland Clinic to complete a validation study of its technology.[35] 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.[36] In August 2016, the company introduced a new robotic, capillary blood testing unit named miniLab to the American Association for Clinical Chemistry, not presenting any data related to its previous test results.[37][38][39]

Corporate affairs

Location

Theranos is headquartered in Palo Alto, California. It has laboratories in Newark, California and Scottsdale, Arizona.[40]

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.[41] In July 2011, Holmes was introduced to former Secretary of State George Shultz, who joined the Theranos board of directors that same month.[42] 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).[42][43][44] The board was criticized for consisting "mainly of directors with diplomatic or military backgrounds."[8]

In April 2016, Theranos announced its medical advisory board which included past presidents or board members of the American Association for Clinical Chemistry.[45] Members were invited to review the company's proprietary technologies and advise on the integration into clinical practice.[45] 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.[46][47]

Balwani left his position as President and COO in May 2016. At that time, the company announced its new board members, Fabrizio Bonanni (former executive vice president of Amgen), Richard Kovacevich and William Foege, (former director of the Centers for Disease Control and Prevention), who would help to publicly introduce its technologies.[48][49][50]

As of May 2016, the Theranos board of directors were:[51]

In December 2016, it was announced the Theranos management team would be restructured with the department of Riley Bechtel. As of December 2016, the Theranos board of directors are:[52]

It was also announced in November 2016 that the celebrity-studded "board of counselors" would be scrapped in January 2017.[53]

Ownership/valuation

A November, 2016, article, looking back, said that the company had been valued in the private market at $9 billion, with Holmes being the majority shareholder, soon after its tests were launched in 2013.[54]

Controversy

The FDA received a formal inquiry to look at Theranos blood test devices by the U.S. Department of Defense in 2012 before the devices were commercially available and did not require FDA approval.[55] 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."[56] After the inspection, Theranos announced that it would voluntarily suspend its tests apart from the FDA-approved herpes simplex virus (HSV-1) test.[57]

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.[58] Theranos claimed that the allegations were "factually and scientifically erroneous and grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents."[59][60] Walgreens suspended plans to expand blood-testing centers in their stores following the report.[61][62] At that time, the Cleveland Clinic announced that it would work to verify Theranos technology.[63]

The Arizona Department of Health Services reported issues with the company's Scottsdale lab meeting regulations in October 2015.[64] In January 2016, the Centers for Medicare and Medicaid Services (CMS) sent a letter to Theranos based on an inspection of its Newark, California lab in the fall of 2015, reporting that the facility did not "comply with certificate requirements and performance standards" and caused an "immediate jeopardy to patient health and safety" due to a test to determine the correct dose of the blood-thinning drug warfarin.[65] In March 2016, CMS regulators announced plans to enact sanctions that included suspending Holmes and Balwani from owning or operating a lab for two years and that they would revoke the lab's license.[66] The company did not receive the sanctions until July.[67] Walgreens and Capital BlueCross announced a suspension of Theranos blood tests from the Newark lab.[68] In May 2016, Theranos announced that it had voided two years of results from its Edison device.[69] The company announced that about 1 percent of test results had been voided or corrected from its proprietary machines in June 2016.[70]

Theranos is under criminal investigation by federal prosecutors and the Securities and Exchange Commission for allegedly misleading investors and government officials about its technology.[71] The case is considered "extremely unusual" by a former assistant U.S. attorney for the Justice Department.[72] The U.S. House of Representatives Committee on Energy and Commerce requested information on what Theranos was doing to correct its testing inaccuracies and adherence to federal guidelines in June 2016.[73][74]

In July 2016, Theranos announced that the CMS had revoked its CLIA certificate as well as sanctions prohibiting its 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. The company discontinued testing at its Newark location while attempting to resolve the issues.[5] Theranos announced plans to appeal the decision by regulators to revoke its license to operate a lab in California and other sanctions.[75] The company withdrew its request for emergency clearance of a Zika virus blood test after a lack of essential safeguards during the testing process was found by federal inspectors in August 2016.[76][77] Theranos announced that it would close its laboratory operations, wellness centers and lay off about 40 percent of its work force to work on miniature medical testing machines in October 2016.[78][79][80][81][79]

In November, 2016, the Wall Street Journal ran a story about Tyler Schultz, the grandson of former Secretary of State and one-time Theranos director George P. Schultz. The younger Schultz was a Theranos employee 2013-14 and, it appears, a critical whistleblower regarding defects in Theranos' technology. The elder Schultz had joined the board in 2011 and been joined soon thereafter by fellow Hoover Institution fellows former Secretary of State Henry Kissinger, former Secretary of Defense William Perry, and former U.S. Senator Sam Nunn (D-GA). "After the Journal published in October 2015 its first article detailing problems at Theranos, the company announced that all four men had been moved from the board of directors to a newly formed board of counselors." David Boies' law firm pursued the younger Schultz aggressively on behalf of the company. While causing significant family and financial strains, in the November 2016 article Tyler Schultz was quoted as having said, “Fraud is not a trade secret .... I refuse to allow bullying, intimidation and threat of legal action to take away my First Amendment right to speak out against wrongdoing.” He had first failed to successfully register his concerns with company management, to which he had special access due to his family connection. He had then been a key Journal source for its October 2015 article and was also, under an alias, the first to report the company to a regulatory body -- New York state’s public-health lab.[54]

See also

References

  1. ↑ Rago, Joseph (2013-09-08). "Elizabeth Holmes: The Breakthrough of Instant Diagnosis". Wall Street Journal. Retrieved 2013-09-16.
  2. ↑ Parloff, Roger (2014-06-12). "This CEO is out for blood". Fortune. Retrieved 2016-04-17.
  3. ↑ 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.
  4. ↑ 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.
  5. 1 2 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.
  6. ↑ "Theranos to Close Labs and Lay Off 340 Workers". New York Times. Retrieved 5 October 2016.
  7. ↑ Weisul, Kimberly (October 2015). "How Playing the Long Game Made Elizabeth Holmes a Billionaire". Inc. (magazine). Retrieved 3 September 2016.
  8. 1 2 3 Leuty, Ron (30 August 2013). "Theranos: The biggest biotech you've never heard of". San Francisco Business Times. Retrieved 9 March 2014.
  9. ↑ 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.
  10. ↑ Bolt, Beth (14 November 2014). "Bringing Painless Blood Testing to the Pharmacy". Pharmacy Times. Retrieved 27 September 2016.
  11. ↑ Crow, David (8 April 2016). "Blood Simple". Financial Times. Retrieved 27 September 2016.
  12. 1 2 Carreyrou, John (27 December 2015). "At Theranos, Many Strategies and Snags". The Wall Street Journal. Retrieved 28 December 2015.
  13. ↑ Leuty, Ron (29 June 2015). "Theranos: Testing times lie ahead for secretive blood-testing firm". American City Business Journals. Retrieved 27 September 2016.
  14. ↑ Klein, Julie (2010-07-08). "Theranos raises $45M to help patients track drug reactions". VentureBeat. Retrieved 2013-09-16.
  15. ↑ Segall, Eli (29 June 2012). "Theranos growing close to home in Palo Alto". Silicon Valley Business Journal. Retrieved 27 September 2016.
  16. ↑ Grossman, Lev (5 May 2016). "The Fall Of Theranos And The Future Of Science In Silicon Valley". TIME (magazine). Retrieved 27 September 2016.
  17. ↑ Loria, Kevin (29 September 2014). "This Woman's Revolutionary Idea Made Her A Billionaire — And Could Change Medicine". Business Insider. Retrieved 27 September 2016.
  18. ↑ Parloff, Roger (2 July 2015). "Disruptive diagnostics firm Theranos gets boost from FDA". Fortune Magazine. Retrieved 16 July 2015.
  19. ↑ Quinn, Michelle (16 July 2015). "Theranos gets another FDA approval for its blood test". Silicon Beat. Retrieved 27 September 2016.
  20. ↑ "AZBio Awards 2015". AzBio.org. 2015. Retrieved 27 September 2016.
  21. ↑ Herper, Matthew. "From $4.5 Billion To Nothing: Forbes Revises Estimated Net Worth of Theranos Founder Elizabeth Holmes". Forbes. Retrieved June 1, 2016.
  22. ↑ Moon, Mariella (18 November 2014). "Walgreens to offer affordable and needle-free blood tests in more stores (updated)". Business Insider. Retrieved 4 September 2016.
  23. ↑ "Young blood". The Economist. 27 June 2015. Retrieved 4 September 2016.
  24. ↑ 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.
  25. ↑ Weaver, Christopher, John Carreyrou and Michael Siconolfi, "Walgreen Sues Theranos, Seeks $140 Million in Damages", Wall Street Journal, November 8, 2016.
  26. ↑ "Theranos, Cleveland Clinic CEO's on innovation partnership". Fox Business. 9 March 2015. Retrieved 4 September 2016.
  27. ↑ George, John (16 July 2016). "Philadelphia health insurer to make lab testing easier for Medicaid members". Philadelphia Business Journal. Retrieved 4 September 2016.
  28. ↑ Chen, Caroline; Tracer, Zachary (8 July 2015). "Fingerprick Lab Test Startup Theranos Strikes Insurance Deal". Bloomberg. Retrieved 4 September 2016.
  29. ↑ Rago, Joseph (8 September 2013). "Elizabeth Holmes: The Breakthrough of Instant Diagnosis". Wall Street Journal. Retrieved 25 July 2016.
  30. ↑ Nguyen, Tuan C. "How To Run 30 Health Tests On a Single Drop of Blood". Smithsonian Magazine. Smithsonian. Retrieved 31 October 2015.
  31. ↑ Loria, Kevin (16 October 2015). "Here's what we know about how Theranos' 'revolutionary' technology works". Tech Insider. Retrieved 25 July 2016.
  32. ↑ "Theranos Chief Yields to Calls for Proof of Blood Test's Reliability". The New York Times. 27 October 2015. Retrieved 26 December 2015.
  33. ↑ Stewart, James B. (October 29, 2015). "The Narrative Frays for Theranos and Elizabeth Holmes". The New York Times. The New York Times Company. Retrieved 31 October 2015.
  34. ↑ Lapowsky, Issie (2015-10-15). "Theranos' Scandal Exposes the Problem With Tech's Hype Cycle". Wired Magazine. Retrieved 2015-11-15.
  35. ↑ "Theranos Has Still Not Begun a Promised Validation Study". Fortune. Retrieved 2016-02-02.
  36. ↑ 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.
  37. ↑ 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.
  38. ↑ Langreth, Robert; Chen, Caroline (1 August 2016). "Expecting Data From Theranos, Lab Experts Get New Product". Bloomberg L.P. Retrieved 1 August 2016.
  39. ↑ Herper, Matthew (1 August 2016). "Theranos Presents Data On New Blood Test Machine, Remains Mum On Previous Technology". Forbes. Retrieved 1 August 2016.
  40. ↑ Abelson, Reed; Creswell, Julie (19 December 2015). "Theranos Founder Faces a Test of Technology, and Reputation". The New York Times. Retrieved 2 July 2016.
  41. ↑ Auletta, Ken (15 December 2014). "Blood, Simpler". The New Yorker. Retrieved 31 May 2016.
  42. 1 2 Parloff, Roger (12 June 2014). "A singular board at Theranos". Fortune. Retrieved 11 May 2016.
  43. ↑ Leuty, Ron (2 August 2013). "Theranos adds Kovacevich to all-star board". San Francisco Business Times. Retrieved 9 March 2014.
  44. ↑ 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.
  45. 1 2 Parloff, Roger (7 April 2016). "Theranos Adds Startlingly Well-Qualified Medical Board". Fortune. Retrieved 14 April 2016.
  46. ↑ Ramsey, Lydia (7 April 2016). "Theranos just made a crucial move that could help its reputation". Business Insider. Retrieved 9 September 2016.
  47. ↑ Weisul, Kimberly (7 April 2016). "Heavy Hitters Join Theranos Advisory Board". Inc. Retrieved 9 September 2016.
  48. ↑ Masunaga, Samantha. "Theranos shuffles leadership; president retires". latimes.com. Los Angeles Times. Retrieved 9 September 2016.
  49. ↑ Carreyrou, John. "Theranos Executive Sunny Balwani to Depart Amid Regulatory Probes". wsj.com. Retrieved 12 May 2016.
  50. ↑ 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.
  51. ↑ Abelson, Reed (11 May 2016). "Embattled Blood Lab Theranos Makes a Bid to Regain Confidence". The New York Times. Retrieved 17 May 2016.
  52. ↑ Ramsey, Lydia. "Theranos Dissolves High-Profile Board of Counselors". Inc. Retrieved 3 December 2016.
  53. ↑ Weaver, Christopher. "Theranos Investor Riley Bechtel Steps Down From Board". Wall Street Journal. Retrieved 3 December 2016.
  54. 1 2 Carreyrou, John (2016-11-17). "Theranos Whistleblower Shook the Company—And His Family". Wall Street Journal. Retrieved 2016-11-17.
  55. ↑ Johnson, Carolyn Y. (2 December 2015). "E-mails reveal concerns about Theranos's FDA compliance date back years". Washington Post. Retrieved 26 December 2015.
  56. ↑ "The FDA's notes from its visit to Theranos' labs don't look good". Business Insider. 27 October 2015. Retrieved 2015-10-27.
  57. ↑ Derla, Katherine (22 October 2015). "Blood-Testing Start-Up Theranos Is In 'Pause Period', Says CEO Elizabeth Holmes". Tech Times. Retrieved 23 October 2016.
  58. ↑ Carreyrou, John. "Hot Startup Theranos Has Struggled With Its Blood-Test Technology". Wall Street Journal. ISSN 0099-9660. Retrieved 2015-10-29.
  59. ↑ "Report Claims Theranos Struggling With Blood Test Tech". Fortune. Retrieved 2015-10-16.
  60. ↑ 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.
  61. ↑ "Walgreens halts expansion of Theranos centers". Fortune Magazine. 24 October 2015. Retrieved 2015-10-25.
  62. ↑ Rosenbloom, Micah (21 November 2015). "In Defense Of Theranos". TechCrunch. Retrieved 23 October 2016.
  63. ↑ DiChristopher, Tom (30 October 2015). "We'll test Theranos tech: Cleveland Clinic CEO". CNBC. Retrieved 23 October 2016.
  64. ↑ "Theranos suspends micro blood tests to allow FDA review". AZ Central. October 25, 2015. Retrieved 2015-10-26.
  65. ↑ "US government says Theranos lab poses 'immediate jeopardy to patient safety'". The Verge. Retrieved 2016-01-27.
  66. ↑ "Theranos Under Fire as U.S. Threatens Crippling Sanctions". New York Times. Retrieved 2016-04-19.
  67. ↑ Ramsey, Lydia (13 April 2016). "US regulators want to bar Elizabeth Holmes from Theranos for 2 years". Business Insider. Retrieved 23 October 2016.
  68. ↑ Ramsey, Lydia (29 January 2016). "Another partner just asked Theranos to stop running blood tests". Business Insider. Retrieved 23 October 2016.
  69. ↑ Carreyrou, John (2016-05-19). "Theranos Voids Two Years of Edison Blood-Test Results". Wall Street Journal. ISSN 0099-9660. Retrieved 2016-05-21.
  70. ↑ Caroline Chen; Rebecca Spalding (June 3, 2016). "Theranos Says Only 1% of Results Affected; Some Doubt Tests". Bloomberg.com. Retrieved June 29, 2016.
  71. ↑ "Don't Blame Silicon Valley for Theranos". The New York Times. 27 April 2016. Retrieved 1 June 2016.
  72. ↑ Lee, Thomas (11 May 2016). "Federal criminal probe of Theranos rings hollow". San Francisco Chronicle. Retrieved 23 October 2016.
  73. ↑ 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.
  74. ↑ Tracer, Zachary. "Theranos Queried on Blood Test Failures by House Democrats". Retrieved 5 July 2016.
  75. ↑ "Theranos to Appeal Regulatory Sanctions" Wall Street Journal,Retrieved 26 August 2016.
  76. ↑ "Troubled Theranos hits another wall as Zika test withdrawn". Washington Post. Retrieved 31 August 2016.
  77. ↑ Carreyrou, John; Weaver, Christopher (30 August 2016). "Theranos Halts New Zika Test After FDA Inspection". Retrieved 6 October 2016 – via Wall Street Journal.
  78. ↑ "Theranos to Close Labs and Lay Off 340 Workers". New York Times. Retrieved 5 October 2016.
  79. 1 2 "An Open Letter From Elizabeth Holmes". theranos.com. 5 October 2016. Retrieved 6 October 2016.
  80. ↑ Post, Washington. "Theranos will close labs and Walgreens testing sites, laying off hundreds". chicagotribune.com. Retrieved 6 October 2016.
  81. ↑ Mole, Beth (5 October 2016). "Theranos throws in the towel on clinical labs, officially pivots to devices". Ars Technica. Retrieved 6 October 2016.
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