Theranos

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Theranos
Formerly
Real-Time Cures
Privately held corporation
IndustryHealth care
FateShut down and liquidated; founder indicted for wire fraud and conspiracy
Founded2003
FounderElizabeth Holmes
DefunctSeptember 2018
Headquarters,
Key people
Elizabeth Holmes (Chairman & CEO)
Ramesh Balwani (President)
ProductsBlood tests
ServicesMedical tests
Websitetheranos.com at the Wayback Machine (archived August 28, 2018)
Footnotes / references
[1]

Theranos (/ˈθɛrəns/) was a privately held health technology corporation,[2] initially touted as a breakthrough technology company, but subsequently infamous for its false claims to have devised blood tests that only needed very small amounts of blood.[3][4][5] Founded in 2003 by then-19-year-old Elizabeth Holmes,[6] Theranos raised more than US$700 million from venture capitalists and private investors,[7] resulting in a $10 billion valuation at its peak in 2013 and 2014.[8][9] Investors and the media hyped Theranos as a breakthrough in the large blood-testing market, where the U.S. diagnostic-lab industry posts annual sales of over $70 billion. Theranos claimed its technology was revolutionary and that its tests required only about 1/100 to 1/1,000 of the amount of blood that would ordinarily be needed and cost far less than existing tests.

A turning point came in October 2015, when investigative reporter John Carreyrou of The Wall Street Journal questioned the validity of Theranos' technology. The company faced a string of legal and commercial challenges from medical authorities, investors, the U.S. Securities and Exchange Commission (SEC), Centers for Medicare and Medicaid Services (CMS), state attorneys general, former business partners, patients, and others.[10] By June 2016, it was estimated that Holmes' personal net worth had dropped from $4.5 billion to virtually nothing.[11] The company was near bankruptcy until it received a $100 million investment from Fortress Investment Group in 2017.[12] In September 2018, the company ceased operations.

In July 2016, Theranos received sanctions from the CMS, including the revocation of its CLIA certificate and prohibition of Holmes and other company officials from owning or operating a lab for two years.[13] Theranos announced it would close its laboratory operations and wellness centers to work on miniature medical testing machines.[14] In April 2017, Theranos said it had reached a settlement agreement with CMS.[15] Following the CMS sanctions, the Walgreens pharmacy chain terminated its contract with Theranos and filed a lawsuit claiming continuous breaches of contract. The suit was settled out of court, with Theranos compensating Walgreens for a much smaller amount than the claimed $140 million, reported at about $30 million.

On March 14, 2018, Theranos, Holmes, and former company president Ramesh "Sunny" Balwani were charged with "massive fraud" by the SEC.[16] One section of the complaint says Holmes falsely claimed in 2014 that the company had annual revenues of $100 million, a thousand times more than the actual figure of $100,000.[17] Theranos and Holmes agreed to resolve the charges against them, with Holmes paying a fine of $500,000, returning the remaining 18.9 million shares that she held, relinquishing her control of the company, and being barred from being an officer or director of any public company for ten years.[18][19] According to the agreement, if Theranos were acquired or otherwise liquidated, Holmes would not profit from her ownership until more than $750 million was returned to investors and other preferred shareholders. Theranos and Holmes neither admitted nor denied the allegations in the SEC's complaint.[7] Balwani did not settle.[20] On June 15, 2018, the U.S. Attorney for the Northern District of California announced the indictment of Holmes on wire fraud and conspiracy charges. Balwani was also indicted on the same charges.[21]

Theranos ceased operations on August 31, 2018, with its General Counsel and new CEO David Taylor and a few support staff remaining on payroll for a few more days.[22]

History[edit]

While at Stanford University, Elizabeth Holmes had an idea to develop a wearable patch that could adjust the dosage of drug delivery and notify doctors of variables in patients' blood.[23] She started developing lab-on-a-chip technology for blood tests, and had the idea for a company that would make testing cheaper, more convenient and accessible to consumers.[24] Holmes dropped out of Stanford[when?] and used the education trust from her parents to found the company that would later be called Theranos, derived from a combination of the words "therapy" and "diagnosis".[25][26] The company's original name was "Real-Time Cures",[8][27][28] which Holmes changed after deciding that too many people were dubious about the word "cure".[8]

Partnerships[edit]

In 2012, Safeway invested $350 million into retrofitting 800 locations with clinics that would offer in-store blood tests. However, after many missed deadlines and questionable results from a trial clinic at Safeway's Corporate offices, the deal was called off in 2015.[29] In September 2013, Theranos partnered with Walgreens to offer in-store blood tests at more than 40 locations. Walgreens announced plans to expand its "wellness centers" across the United States.[30] Theranos 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] In November 2016, Walgreen Co. filed suit against Theranos in a federal court in Delaware, for breach of contract. Theranos reported to investors on June 21, 2017 that the suit, which originally sought $140 million in damages, was settled for less than $30 million.[33][34]

In March 2015 the Cleveland Clinic announced a partnership with Theranos to test its technology in order to decrease the cost of lab tests.[35] Theranos became the lab-work provider for Pennsylvania insurers AmeriHealth Caritas and Capital BlueCross in July 2015.[36][37]

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.[38][39] Theranos was awarded the 2015 Bioscience Company of the Year by AzBio.[40]

Exposure and downfall[edit]

In October 2015, John Carreyrou of The Wall Street Journal reported that Theranos was using traditional blood testing machines to run its tests instead of the company's Edison devices, and that the company's Edison machines might provide inaccurate results.[41][42] Theranos claimed that the allegations were "factually and scientifically erroneous and grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents".[43][44] Walgreens suspended plans to expand blood-testing centers in their stores following the report.[45][46] At that time, the Cleveland Clinic announced that it would work to verify Theranos technology.[47] Theranos fought back against the Journal's investigation, sending lawyers after sources in the story in an effort to stop them from providing information to the press.[4] Tyler Shultz was a key source for the WSJ story. Shultz was a Theranos employee from 2013 to 2014 and the grandson of then Theranos director, former U.S. Secretary of State George P. Shultz. Tyler Shultz had attempted to bring concerns about the company's activities to his management, and when that had failed, he had spoken to Carreyrou and also, under an alias, reported the company to the New York State Department of Health.[48]

Following the WSJ story, the history of FDA interactions with Theranos was scrutinized. The FDA had 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.[49] 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".[50] The FDA inspection in 2015 resulted in multiple 483s from the FDA where inspectors observed violations of FDA Title 21 Regulations.[51][52] After the inspection, Theranos announced that it would voluntarily suspend its tests apart from the FDA-approved herpes simplex virus (HSV-1) test.[53]

The Arizona Department of Health Services reported issues with the company's Scottsdale lab meeting regulations in September 2015. The reports in which these issues were documented were revealed in the Arizona Republic in November 2015.[54]

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 fall 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.[55] Walgreens and Capital BlueCross announced a suspension of Theranos blood tests from the Newark lab.[56]

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.[57] The company did not receive the sanctions until July.[58]

By April 2016 Theranos came under criminal investigation by federal prosecutors and the SEC for allegedly misleading investors and government officials about its technology.[59] The case is considered "extremely unusual" by a former assistant U.S. attorney for the Justice Department.[60] 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.[61][62]

In May 2016, Theranos announced that it had voided two years of results from its Edison device.[63] The company announced that about 1 percent of test results had been voided or corrected from its proprietary machines in June 2016.[64]

In July 2016, Theranos announced that the CMS had revoked its CLIA certificate and issued 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.[13] Theranos announced plans to appeal the decision by regulators to revoke its license to operate a lab in California and other sanctions.[65]

In August 2016 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.[66][67]

Theranos announced that it would close its laboratory operations and wellness centers and lay off about 40 percent of its work force to work on miniature medical testing machines in October 2016.[14][68][69][70][68]

In January 2017, Theranos announced that it had laid off 41 percent of its workforce, or approximately 155 people, and closed the last remaining blood-testing facility after the lab failed a second major U.S. regulatory inspection.[71][72]

Also that month, the company faced lawsuits from several different entities including Walgreens[73][74] and the Arizona Attorney General.[75]

In April 2017, lawyers for Partner Investments LP and two other funds, with combined stakes totaling more than $96 million in Theranos preferred shares, charged that Theranos had threatened to seek bankruptcy protection if the investors did not agree to accept additional stock equity in lieu of litigation. Theranos officials said the funds had mischaracterized the exchange offer, which was discussed before the suit was filed.[76] The suit also alleged that Theranos Inc. had misled company directors about its practices concerning laboratory testing and that it had secretly bought lab equipment to run fake demonstrations.[77] The case was settled on May 1, 2017.[78] On May 1, 2017, Theranos announced that it had reached an undisclosed settlement with Partner Fund Management LP. Theranos' General Counsel David Taylor stated: "Theranos is pleased to have resolved both lawsuits with PFM. Although we are confident that we would have prevailed at trial, resolution of these two cases allows our tender offer to go forward and enables us to return our focus where it belongs, which is on executing our business plans and delivering value for our shareholders."[79]

In April 2017, Theranos reached a settlement with CMS agreeing to stay out of the blood-testing business for at least two years in exchange for reduced penalties,[80] and signed a consent decree with the state of Arizona over violations of the Arizona Consumer Fraud Act. Alleged violations included false advertisement and inaccurate blood testing. Theranos agreed to refund $4.65 million to the state's residents for Theranos blood testing services, regardless of whether the test results were voided or corrected.[81][82][83][84]

In August 2017, Theranos announced it had reached a settlement with Walgreens.[85]

In December 2017, Fortress Investment Group loaned $100 million to Theranos. Theranos had reportedly been on the verge of bankruptcy, with the loan meant to keep the company solvent into 2018.[12][86][87] The loan was secured by Theranos' patents.[88] On April 10, 2018, the company laid off the majority of workers in a renewed bid to avoid bankruptcy. The company's total headcount was down to fewer than 25 employees, after having 800 employees at its peak.[1][89]

In March 2018 the US Securities and Exchange Commission charged Theranos, its CEO Elizabeth Holmes and former president Ramesh "Sunny" Balwani, claiming they had engaged in an "elaborate, years-long fraud" wherein they "deceived investors into believing that its key product – a portable blood analyzer – could conduct comprehensive blood tests from finger drops of blood."[90][91] Holmes reached a settlement with the SEC, which requires her to pay $500,000, forfeit 19 million shares of company stock, and be barred from having a leadership position in any public company for ten years.[92] Balwani did not settle with the SEC.[93]

On June 15, 2018, Holmes and Balwani were indicted on multiple counts of wire fraud and conspiracy to commit wire fraud. According to the indictment, investors and doctors and patients were defrauded. It is alleged the defendants were aware of the unreliability and inaccuracy of their products, but concealed that information. If convicted, they each face a maximum fine of $250,000 and 20 years in prison. The case has been assigned to Lucy H. Koh, United States District Judge of the United States District Court for the Northern District of California.[94][95]

Shutdown[edit]

On September 4, 2018, Theranos announced in an email to investors that it would cease operations and release its assets and remaining cash to creditors after all efforts to find a buyer came to nothing. Most of the company's remaining employees were laid off on the previous Friday, August 31. However, Theranos' General Counsel and new CEO David Taylor and a few support staffers remained on payroll for a few more days.[96] The Wall Street Journal reported that any equity investments in the company were made worthless by the shutdown.

Technology and products[edit]

Theranos claimed to have developed devices to automate and miniaturize blood tests using microscopic blood volumes. Theranos dubbed its blood collection vessel the "nanotainer" and its analysis machine the "Edison."[97][98][99] The technology has been criticized for not being peer reviewed.[100][101] Theranos claimed to have data verifying the accuracy and reliability of its tests that would be published.[102] In February 2016, Theranos announced that it would permit the Cleveland Clinic to complete a validation study of its technology.[103] In March 2016, a study authored by 13 scientists appeared in the Journal of Clinical Investigation, where it was stated that the company's blood test results were flagged "outside their normal range 1.6x more often than other testing services", that 68 percent of lab measurements evaluated "showed significant interservice variability", and that "lipid panel test results between Theranos and other clinical services" were "nonequivalent".[104] In August 2016, the company introduced a new robotic, capillary blood testing unit named "miniLab" at the 2016 annual meeting of the American Association for Clinical Chemistry, but did not present any data supporting the claimed abilities of the device.[105][106][107]

Corporate affairs[edit]

Location[edit]

Theranos was headquartered in Palo Alto, California. It previously had laboratories in Newark, California and Scottsdale, Arizona.[108]

Management[edit]

Elizabeth Holmes, the chief executive officer and founder of Theranos in 2013.
Elizabeth Holmes, the chief executive officer and founder of Theranos in 2013.

From its incorporation in 2003 until 2018, Holmes was 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. Holmes' then-boyfriend Sunny Balwani, a software engineer whom Holmes had met during high school, joined the company as its president and chief operating officer in 2009.[109] In July 2011, Holmes was introduced to former U.S. Secretary of State George P. Shultz, who joined the Theranos board of directors that month.[110] Over the next three years, Shultz helped to introduce almost all the outside directors on the "all-star board," which included William Perry (former U.S. Secretary of Defense), Henry Kissinger (former U.S. 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).[110][111][112] The board was criticized for consisting "mainly of directors with diplomatic or military backgrounds."[24]

In April 2016, Theranos announced its medical advisory board which included past presidents or board members of the American Association for Clinical Chemistry.[113] Members were invited to review the company's proprietary technologies and advise on the integration into clinical practice.[113] 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 (CDC), 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.[114][115]

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, who would help to publicly introduce its technologies.[116][117][118]

In May 2016 members of the Theranos board of directors were:[119]

In December 2016, it was announced the Theranos management team would be restructured with the departure of Riley Bechtel. In January 2017 incoming U.S. Secretary of Defense nominee James Mattis resigned from the Theranos board. In January 2017 the Theranos board of directors included:[120] Elizabeth Holmes, William Foege, Fabrizio Bonanni, and Daniel Warmenhoven, former NetApp CEO, who replaced Riley Bechtel

It was also announced in November 2016 that the celebrity-studded "board of counselors" would be scrapped in January 2017.[121]

Valuation[edit]

Theranos raised millions of dollars in its first years. In 2004, Theranos was based in a rented basement near the Stanford campus.[122] By December 2004 the company had more than $6 million from investors at a valuation of $30 million.[123] The company had about $45 million total fundraising after Series B and Series C funding in 2006.[124] Theranos raised an additional $45 million in 2010 at a valuation of $1 billion.[123][125] The company moved to the former headquarters of Facebook in June 2012.[126][127] The company had significant news coverage starting in September 2013 after profiles in the San Francisco Business Times and Wall Street Journal.[24] By 2014, Theranos had raised more than $400 million with an estimated value of $9 billion.[128] In 2016, Forbes revised the estimated net worth of the company to $800 million taking into account the $724 million of capital raised.[11]

In May 2017, participating shareholders provided a release of any potential claims against Theranos in exchange for shares of the company's new preferred stock. Holders of more than 99 percent of the shares elected to participate. CEO Elizabeth Holmes contributed shares to the company and gave up equity to offset potential dilution to non-participating shareholders.[129]

In May 2018 John Carreyrou reported that American business and government leaders lost more than $600 million by privately investing in Theranos.[130] Major investments had been made by the Walton family ($150 million), Rupert Murdoch ($121 million), Betsy DeVos ($100 million), and the Cox family (of Cox Media Group) ($100 million).[13] The final liquidation of the company in September 2018 rendered these investments completely worthless.[96]

In books and documentaries[edit]

John Carreyrou, the Wall Street Journal reporter whose work exposed Theranos, published a book-length treatment in May 2018 titled Bad Blood: Secrets and Lies in a Silicon Valley Startup.[131] As of June 2016, a film version was in the works starring Jennifer Lawrence as Elizabeth Holmes, written by Vanessa Taylor and directed by Adam McKay.[132]

In January 2019, ABC News Nightline released a podcast and documentary about the Holmes story called The Dropout.[133]

Alex Gibney created a documentary titled The Inventor: Out for Blood in Silicon Valley about Holmes and Theranos, which made its official debut at the Sundance Film Festival in Park City, Utah on January 24, 2019.[134]

See also[edit]

References[edit]

  1. ^ a b Mukherjee, Sy (April 10, 2018). "Report: Theranos Just Laid Off the Vast Majority of Its Employees". Fortune. Retrieved April 11, 2018.
  2. ^ "Amended Statement by Foreign Corporation" (pdf). California Secretary State Business Search. April 21, 2004. Retrieved July 23, 2018. C2651481
  3. ^ Bilton, Nick (September 6, 2016). "Exclusive: How Elizabeth Holmes's House of Cards Came Tumbling Down". Vanity Fair. Retrieved December 3, 2018.
  4. ^ a b John Carreyrou (May 21, 2018). Bad Blood: Secrets and Lies in a Silicon Valley Startup. Knopf Doubleday Publishing Group. ISBN 978-1-5247-3166-3.
  5. ^ Levine, Matt (March 14, 2018). "The Blood Unicorn Theranos Was Just a Fairy Tale". Bloomberg View. Retrieved March 14, 2018.
  6. ^ Rago, Joseph (September 8, 2013). "Elizabeth Holmes: The Breakthrough of Instant Diagnosis". Wall Street Journal. Archived from the original on October 19, 2013. Retrieved September 16, 2013.
  7. ^ a b Salzman, Avi. "Theranos: From Unicorn Hype to 'Massive Fraud'". Barron's. Retrieved March 31, 2018.
  8. ^ a b c Parloff, Roger (June 12, 2014). "This CEO is out for blood". Fortune. Retrieved April 17, 2016.
  9. ^ Johnson, Carolyn Y. (October 15, 2015). "The wildly hyped $9 billion blood test company that no one really understands". The Washington Post. ISSN 0190-8286. Retrieved October 29, 2015.
  10. ^ Ableson, Reed (April 18, 2016). "Theranos Under Federal Criminal Investigation, Adding to Its Woes". New York Times. Retrieved April 18, 2018.
  11. ^ a b Herper, Matthew (June 1, 2016). "From $4.5 Billion To Nothing: Forbes Revises Estimated Net Worth of Theranos Founder Elizabeth Holmes". Forbes. Retrieved June 1, 2016.
  12. ^ a b Carreyrou, John (December 24, 2017). "Blood-Testing Firm Theranos Gets $100 Million Lifeline From Fortress". Wall Street Journal. Retrieved March 14, 2018. (Subscription required (help)).
  13. ^ a b c Carreyrou, John; Siconolfi, Michael; Weaver, Christopher (July 8, 2016). "Theranos Dealt Sharp Blow as Elizabeth Holmes Is Banned From Operating Labs". Wall Street Journal. ISSN 0099-9660. Retrieved July 9, 2016.
  14. ^ a b "Theranos to Close Labs and Lay Off 340 Workers". New York Times. Retrieved October 5, 2016.
  15. ^ "Theranos Reaches Resolution with Centers For Medicare & Medicaid Services" (Press release). Theranos Newsroom. April 17, 2017.
  16. ^ "Theranos founder Elizabeth Holmes charged with 'massive fraud'". USA Today.
  17. ^ Aiello, Chloe (March 14, 2018). "Theranos president exaggerated the company's revenue by 1,000x to investors, says SEC". CNBC. Retrieved May 26, 2018.
  18. ^ Thomas, Katie (March 14, 2018). "Elizabeth Holmes, Theranos C.E.O. and Silicon Valley Star, Accused of Fraud". New York Times. Retrieved March 14, 2018.
  19. ^ "Theranos founder Elizabeth Holmes charged with 'massive fraud'". USA Today. Retrieved March 14, 2018.
  20. ^ Balakrishnan, Anita (March 14, 2018). "Theranos CEO Holmes and former president Balwani charged with massive fraud". CNBC. Retrieved May 26, 2018.
  21. ^ O'Brien, Sarah Ashley. "Elizabeth Holmes indicted on wire fraud charges, steps down from Theranos". CNN. CNN. Retrieved June 15, 2018.
  22. ^ https://www.wsj.com/articles/blood-testing-firm-theranos-to-dissolve-1536115130
  23. ^ Weisul, Kimberly (October 2015). "How Playing the Long Game Made Elizabeth Holmes a Billionaire". Inc. Retrieved September 3, 2016.
  24. ^ a b c Leuty, Ron (August 30, 2013). "Theranos: The biggest biotech you've never heard of". San Francisco Business Times. Retrieved March 9, 2014.
  25. ^ Roper, Caitlin (February 18, 2014). "This Woman Invented a Way to Run 30 Lab Tests on Only One Drop of Blood". Wired. Retrieved September 27, 2016.
  26. ^ Bolt, Beth (November 14, 2014). "Bringing Painless Blood Testing to the Pharmacy". Pharmacy Times. Retrieved September 27, 2016.
  27. ^ Hu, Charlotte; Ramsey, Lydia (May 25, 2018). "The rise and fall of Theranos, the blood-testing startup that went from a rising star in Silicon Valley to facing fraud charges over a wild 15-year span". Business Insider. Retrieved June 11, 2018.
  28. ^ Stockton, Nick (May 4, 2016). "Everything You Need to Know About the Theranos Saga So Far". Wired. Retrieved June 11, 2018.
  29. ^ "Safeway severs ties with Theranos as $350M deal collapses". www.fiercebiotech.com. Retrieved 2019-03-09.
  30. ^ Moon, Mariella (November 18, 2014). "Walgreens to offer affordable and needle-free blood tests in more stores (updated)". Business Insider. Retrieved September 4, 2016.
  31. ^ "Young blood". The Economist. June 27, 2015. Retrieved September 4, 2016.
  32. ^ Duhaime-Ross, Arielle (October 26, 2015). "Theranos didn't work with the huge drug company it supposedly made money from, drug company says". The Verge. Retrieved October 29, 2015.
  33. ^ Weaver, Christopher, John Carreyrou and Michael Siconolfi, "Walgreen Sues Theranos, Seeks $140 Million in Damages", Wall Street Journal, November 8, 2016.
  34. ^ Thomas, Lauren (June 21, 2017). "Theranos, Walgreens reportedly reach a deal to settle suit for under $30 million". CNBC. Retrieved June 21, 2017.
  35. ^ "Theranos, Cleveland Clinic CEO's on innovation partnership". Fox Business. March 9, 2015. Retrieved September 4, 2016.
  36. ^ George, John (July 16, 2016). "Philadelphia health insurer to make lab testing easier for Medicaid members". Philadelphia Business Journal. Retrieved September 4, 2016.
  37. ^ Chen, Caroline; Tracer, Zachary (July 8, 2015). "Fingerprick Lab Test Startup Theranos Strikes Insurance Deal". Bloomberg. Retrieved September 4, 2016.
  38. ^ Parloff, Roger (July 2, 2015). "Disruptive diagnostics firm Theranos gets boost from FDA". Fortune. Retrieved July 16, 2015.
  39. ^ Quinn, Michelle (July 16, 2015). "Theranos gets another FDA approval for its blood test". Silicon Beat. Retrieved September 27, 2016.
  40. ^ "AZBio Awards 2015". AzBio.org. 2015. Retrieved September 27, 2016.
  41. ^ Bilton, Nick. "Exclusive: How Elizabeth Holmes's House of Cards Came Tumbling Down". The Hive. Retrieved April 22, 2017.
  42. ^ Carreyrou, John. "Hot Startup Theranos Has Struggled With Its Blood-Test Technology". Wall Street Journal. ISSN 0099-9660. Retrieved October 29, 2015.
  43. ^ "Report Claims Theranos Struggling With Blood Test Tech". Fortune. Retrieved October 16, 2015.
  44. ^ Dawn Chmielewski. "Theranos Attacks Wall Street Journal (Again) in a Rebuttal You'll Need a Medical Degree to Understand". Re/code. Retrieved December 26, 2015.
  45. ^ "Walgreens halts expansion of Theranos centers". Fortune. October 24, 2015. Retrieved October 25, 2015.
  46. ^ Rosenbloom, Micah (November 21, 2015). "In Defense Of Theranos". TechCrunch. Retrieved October 23, 2016.
  47. ^ DiChristopher, Tom (October 30, 2015). "We'll test Theranos tech: Cleveland Clinic CEO". CNBC. Retrieved October 23, 2016.
  48. ^ Carreyrou, John (November 17, 2016). "Theranos Whistleblower Shook the Company – And His Family". Wall Street Journal. Retrieved November 17, 2016.
  49. ^ Johnson, Carolyn Y. (December 2, 2015). "E-mails reveal concerns about Theranos's FDA compliance date back years". Washington Post. Retrieved December 26, 2015.
  50. ^ "The FDA's notes from its visit to Theranos' labs don't look good". Business Insider. October 27, 2015. Retrieved October 27, 2015.
  51. ^ "FDA-483" (PDF). FDA. September 16, 2015.
  52. ^ "FDA-483" (PDF). FDA. September 16, 2015.
  53. ^ Derla, Katherine (October 22, 2015). "Blood-Testing Start-Up Theranos Is In 'Pause Period', Says CEO Elizabeth Holmes". Tech Times. Retrieved October 23, 2016.
  54. ^ "Arizona inspectors find Theranos lab issues". Arizona Republic. November 27, 2015. Retrieved March 20, 2019.
  55. ^ "US government says Theranos lab poses 'immediate jeopardy to patient safety'". The Verge. Retrieved January 27, 2016.
  56. ^ Ramsey, Lydia (January 29, 2016). "Another partner just asked Theranos to stop running blood tests". Business Insider. Retrieved October 23, 2016.
  57. ^ "Theranos Under Fire as U.S. Threatens Crippling Sanctions". New York Times. Retrieved April 19, 2016.
  58. ^ Ramsey, Lydia (April 13, 2016). "US regulators want to bar Elizabeth Holmes from Theranos for 2 years". Business Insider. Retrieved October 23, 2016.
  59. ^ "Don't Blame Silicon Valley for Theranos". The New York Times. April 27, 2016. Retrieved June 1, 2016.
  60. ^ Lee, Thomas (May 11, 2016). "Federal criminal probe of Theranos rings hollow". San Francisco Chronicle. Retrieved October 23, 2016.
  61. ^ Lagasse, Jeff (July 1, 2016). "Theranos founder Elizabeth Holmes asked by Congressional committee to detail company's compliance efforts". Healthcare Finance News. Retrieved July 2, 2016.
  62. ^ Tracer, Zachary. "Theranos Queried on Blood Test Failures by House Democrats". Retrieved July 5, 2016.
  63. ^ Carreyrou, John (May 19, 2016). "Theranos Voids Two Years of Edison Blood-Test Results". Wall Street Journal. ISSN 0099-9660. Retrieved May 21, 2016.
  64. ^ Caroline Chen; Rebecca Spalding (June 3, 2016). "Theranos Says Only 1% of Results Affected; Some Doubt Tests". Bloomberg. Retrieved June 29, 2016.
  65. ^ "Theranos to Appeal Regulatory Sanctions" Wall Street Journal, Retrieved August 26, 2016.
  66. ^ "Troubled Theranos hits another wall as Zika test withdrawn". Washington Post. Retrieved August 31, 2016.
  67. ^ Carreyrou, John; Weaver, Christopher (August 30, 2016). "Theranos Halts New Zika Test After FDA Inspection". Retrieved October 6, 2016 – via Wall Street Journal.
  68. ^ a b "An Open Letter From Elizabeth Holmes". Theranos. October 5, 2016. Retrieved October 6, 2016.
  69. ^ Post, Washington. "Theranos will close labs and Walgreens testing sites, laying off hundreds". Chicago Tribune. Retrieved October 6, 2016.
  70. ^ Mole, Beth (October 5, 2016). "Theranos throws in the towel on clinical labs, officially pivots to devices". Ars Technica. Retrieved October 6, 2016.
  71. ^ Christopher Weaver (January 17, 2017). "Second Theranos Lab Failed U.S. Inspection". The Wall Street Journal. Retrieved January 18, 2017.
  72. ^ Jon Russell (January 18, 2017). "Theranos closes its last remaining blood-testing lab after it reportedly failed an inspection". TechCrunch. Retrieved January 18, 2017.
  73. ^ O'Brien, Sara Ashley (January 6, 2017). "Theranos fires 41% of staffers". CNN. Retrieved January 10, 2017.
  74. ^ Chen, Caroline. "Theranos to fire 41 percent of workforce in second round of cuts". Chicago Tribune. Retrieved January 10, 2017.
  75. ^ "Arizona AG plans to sue Theranos over blood-testing devices". Reuters. January 12, 2017. Retrieved January 12, 2017.
  76. ^ "Theranos Investors Say They Were Pressured to Abandon Lawsuit". Bloomberg. April 19, 2017. Retrieved April 20, 2017.
  77. ^ Weaver, Christopher (April 22, 2017). "Theranos Secretly Bought Outside Lab Gear, Ran Fake Tests: Court Filings". Wall Street Journal. ISSN 0099-9660. Retrieved April 22, 2017.
  78. ^ "Theranos Reaches Steelement with Partner Fund Management" (Press release). Theranos. May 1, 2017. Retrieved September 28, 2017.
  79. ^ "Theranos Reaches Settlement with Partner Fund Management" (Press release). Theranos. May 1, 2017. Retrieved May 2, 2017.
  80. ^ Weaver, Christopher. "Theranos agrees to 2-year ban on clinical blood work". MarketWatch. Retrieved April 28, 2017.
  81. ^ "Theranos, Arizona Attorney General Reach Agreement on Full Restitution to State Consumers" (Press release). Theranos. April 18, 2017.
  82. ^ Mole, Beth (April 18, 2017). "With $4.65M deal, Arizonans will get their money back from Theranos". Ars Technica. Retrieved April 18, 2017.
  83. ^ Sy Mukherjee, Theranos Just Reached a Deal With Investors to Avoid Lawsuits Fortune, May 16, 2017
  84. ^ Howard Fischer, Theranos will refund $4.6M to Arizonans who took its blood tests White Mountain Independent April 21, 2017
  85. ^ "Theranos Reaches Settlement with Walgreens" (Press release). Theranos. August 1, 2017.
  86. ^ Morris, David Z. (December 23, 2017). "Theranos Secures $100 Million in New Funding from Fortress Capital". Fortune.
  87. ^ Sheetz, Michael (December 26, 2017). "Theranos dodges bankruptcy after $100 million loan: Report". CNBC. Retrieved January 15, 2018.
  88. ^ Joel Rosentblatt, "Theranos Investors Turn Scavengers on Wounded Unicorn's Remains", Bloomberg Technology, 28 March, 2018
  89. ^ "Theranos Lays Off Most Of Its Workforce". PYMNTS. April 11, 2018. Retrieved April 12, 2018.
  90. ^ Johnson, Carolyn Y. (March 14, 2018). "Theranos chief executive Elizabeth Holmes charged with massive fraud". Washington Post.
  91. ^ "Securities and Exchange Commission, vs. Elizabeth Holmes and Theranos, Inc., Complaint" (PDF). sec.gov. SEC. Retrieved March 14, 2018.
  92. ^ Robinson, Matt (March 14, 2018). "Theranos and CEO Elizabeth Holmes Accused of Fraud by SEC". Bloomberg News. Retrieved March 14, 2018.
  93. ^ Balakrishnan, Anita (March 14, 2018). "Theranos CEO Holmes and former president Balwani charged with massive fraud". CNBC. Retrieved March 14, 2018.
  94. ^ "Theranos Founder and Former Chief Operating Officer Charged In Alleged Wire Fraud Schemes" (Press release). justice.gov. United States Department of Justice. June 15, 2018. Retrieved June 16, 2018. Elizabeth Holmes and Ramesh "Sunny" Balwani Are Alleged To Have Perpetrated Multi-million Dollar Schemes To Defraud Investors, Doctors, and Patients.
  95. ^ http://money.cnn.com/2018/06/15/technology/elizabeth-holmes-indicted-theranos/index.html
  96. ^ a b Carreyrou, John. "Blood-Testing Firm Theranos to Dissolve". Wall Street Journal.
  97. ^ Rago, Joseph (September 8, 2013). "Elizabeth Holmes: The Breakthrough of Instant Diagnosis". Wall Street Journa]. Retrieved July 25, 2016.
  98. ^ Nguyen, Tuan C. "How To Run 30 Health Tests On a Single Drop of Blood". Smithsonian Magazine. Smithsonian. Retrieved October 31, 2015.
  99. ^ Loria, Kevin (October 16, 2015). "Here's what we know about how Theranos' 'revolutionary' technology works". Tech Insider. Retrieved July 25, 2016.
  100. ^ Stewart, James B. (October 29, 2015). "The Narrative Frays for Theranos and Elizabeth Holmes". New York Times. Retrieved October 31, 2015.
  101. ^ Lapowsky, Issie (October 15, 2015). "Theranos' Scandal Exposes the Problem With Tech's Hype Cycle". Wired. Retrieved November 15, 2015.
  102. ^ "Theranos Chief Yields to Calls for Proof of Blood Test's Reliability". The New York Times. October 27, 2015. Retrieved December 26, 2015.
  103. ^ "Theranos Has Still Not Begun a Promised Validation Study". Fortune. Retrieved February 2, 2016.
  104. ^ Kidd, Brian; et al. (March 28, 2016). "Evaluation of direct-to-consumer low-volume lab tests in healthy adults". Journal of Clinical Investigation. Retrieved June 21, 2017.
  105. ^ Abelson, Reed (June 1, 2016). "Elizabeth Holmes, Founder of Theranos, Falls From Highest Perch Off Forbes List". New York Times. Retrieved July 25, 2016.
  106. ^ Langreth, Robert; Chen, Caroline (August 1, 2016). "Expecting Data From Theranos, Lab Experts Get New Product". Bloomberg. Retrieved August 1, 2016.
  107. ^ Herper, Matthew (August 1, 2016). "Theranos Presents Data On New Blood Test Machine, Remains Mum On Previous Technology". Forbes. Retrieved August 1, 2016.
  108. ^ Abelson, Reed; Creswell, Julie (December 19, 2015). "Theranos Founder Faces a Test of Technology, and Reputation". The New York Times. Retrieved July 2, 2016.
  109. ^ Auletta, Ken (December 15, 2014). "Blood, Simpler". The New Yorker. Retrieved May 31, 2016.
  110. ^ a b Parloff, Roger (June 12, 2014). "A singular board at Theranos". Fortune. Retrieved May 11, 2016.
  111. ^ Leuty, Ron (August 2, 2013). "Theranos adds Kovacevich to all-star board". San Francisco Business Times. Retrieved March 9, 2014.
  112. ^ Leuty, Ron (July 29, 2013). "Quiet Theranos adds former Wells chief Kovacevich, 'Mad Dog' Mattis to power-packed board". San Francisco Business Times. Retrieved March 9, 2014.
  113. ^ a b Parloff, Roger (April 7, 2016). "Theranos Adds Startlingly Well-Qualified Medical Board". Fortune. Retrieved April 14, 2016.
  114. ^ Ramsey, Lydia (April 7, 2016). "Theranos just made a crucial move that could help its reputation". Business Insider. Retrieved September 9, 2016.
  115. ^ Weisul, Kimberly (April 7, 2016). "Heavy Hitters Join Theranos Advisory Board". Inc. Retrieved September 9, 2016.
  116. ^ Masunaga, Samantha. "Theranos shuffles leadership; president retires". Los Angeles Times. Retrieved September 9, 2016.
  117. ^ Carreyrou, John. "Theranos Executive Sunny Balwani to Depart Amid Regulatory Probes". Wall Street Journal. Retrieved May 12, 2016.
  118. ^ della Cava, Marco. "Theranos COO departs as embattled startup adds to board". USA Today. Retrieved May 12, 2016. Theranos also is adding former Amgen executive Fabrizio Bonanni to its board.
  119. ^ Abelson, Reed (May 11, 2016). "Embattled Blood Lab Theranos Makes a Bid to Regain Confidence". The New York Times. Retrieved May 17, 2016.
  120. ^ Ramsey, Lydia. "Theranos Dissolves High-Profile Board of Counselors". Inc. Retrieved December 3, 2016.
  121. ^ Weaver, Christopher. "Theranos Investor Riley Bechtel Steps Down From Board". Wall Street Journal. Retrieved December 3, 2016.
  122. ^ Crow, David (April 8, 2016). "Blood Simple". Financial Times. (Subscription required (help)).
  123. ^ a b Carreyrou, John (December 27, 2015). "At Theranos, Many Strategies and Snags". Wall Street Journal. Retrieved December 28, 2015.
  124. ^ Leuty, Ron (June 29, 2015). "Theranos: Testing times lie ahead for secretive blood-testing firm". American City Business Journals. Retrieved September 27, 2016.
  125. ^ Klein, Julie (July 8, 2010). "Theranos raises $45M to help patients track drug reactions". VentureBeat. Retrieved September 16, 2013.
  126. ^ Segall, Eli (June 29, 2012). "Theranos growing close to home in Palo Alto". Silicon Valley Business Journal. Retrieved September 27, 2016.
  127. ^ Grossman, Lev (May 5, 2016). "The Fall Of Theranos And The Future Of Science In Silicon Valley". Time. Retrieved September 27, 2016.
  128. ^ Loria, Kevin (September 29, 2014). "This Woman's Revolutionary Idea Made Her A Billionaire – And Could Change Medicine". Business Insider. Retrieved September 27, 2016.
  129. ^ "Theranos Finalizes Shareholder Recapitalization". Businesswire. Retrieved May 19, 2017.
  130. ^ John Carreyrou (May 3, 2018). "Theranos Cost Business and Government Leaders More Than $600 Million". Wall Street Journal. Retrieved May 5, 2018.
  131. ^ "How One Company Scammed Silicon Valley. And How It Got Caught". The New York Times. May 21, 2018. ISSN 0362-4331. Retrieved May 22, 2018.
  132. ^ McNary, Dave (June 23, 2016). "Legendary Wins Bidding War for Jennifer Lawrence Movie 'Bad Blood'". Variety. Archived from the original on June 25, 2016. Retrieved July 23, 2018.
  133. ^ The Dropout. ABC News Nightline.
  134. ^ Debruge, Peter (November 28, 2018). "Sundance Film Festival Unveils 2019 Features Lineup". Variety. Retrieved March 5, 2019.

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