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Theranos
Theranos
(/ˈθɛrənoʊs/) is a privately held health technology company known for its false claims to have devised revolutionary blood tests that used very small amounts of blood.[2] Founded in 2003 by 19-year old Elizabeth Holmes,[3] Theranos
Theranos
raised more than $700 million from venture capitalists, private investors and funds[4] resulting in a $9 billion valuation at its peak in 2013 and 2014.[5][6][7] Investors and the media viewed Theranos
Theranos
as a breakthrough in the large blood testing market, with the diagnostic-lab industry posting annual sales of over $70 billion just in the US. Theranos
Theranos
claimed its technology was revolutionary for a number reasons. It requires only about 1/100th to 1/1,000th of the amount that would ordinarily be needed, and it costs less than other blood tests, with prices often half to a quarter of independent lab prices and a quarter to a tenth of hospital lab prices. Also, it uses a finger stick instead of a needle, alleviating fears of many patients that, in the most extreme cases, prefer to forgo blood testing, and test results are available within hours. A turning point occurred in October 2015, when investigative reporter John Carreyrou of The Wall Street Journal
The Wall Street Journal
questioned the validity of its technology. Since then, Theranos
Theranos
has faced a string of legal and commercial challenges from medical authorities, investors, the U.S. Securities and Exchange Commission, Centers for Medicare and Medicaid Services, state attorneys general, former business partners, and others.[citation needed] By June 2016, it was estimated that Holmes' personal net worth had dropped from $4.5 billion to virtually nothing,[1] and the company was near bankruptcy until it received a $100 million investment from Fortress Investment Group
Fortress Investment Group
in 2017.[8] In July 2016, Theranos
Theranos
received sanctions from the Centers for Medicare and 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.[9] Theranos
Theranos
announced that it would close its laboratory operations and wellness centers to work on miniature medical testing machines in October 2016.[10] In April 2017, Theranos
Theranos
announced that it had reached a settlement agreement with CMS.[11] In 2016, Walgreens, one of the largest pharmacy chains in the US, terminated its contract with Theranos
Theranos
then a few months later filed a lawsuit claiming continuous breach of contracts. The suit was later settled out of court, with Theranos
Theranos
compensating Walgreens
Walgreens
for a much smaller amount than the claimed $140 million, reported at about $30 million.[citation needed] On March 14, 2018, Holmes, former Theranos
Theranos
President Ramesh "Sunny" Balwani and Theranos
Theranos
were charged with "massive fraud" by the U.S. Securities and Exchange Commission.[12] Theranos
Theranos
and Holmes have agreed to resolve the charges against them. Holmes will pay a fine of $500,000, return the remaining 18.9 million shares that she obtained during the fraud, relinquish her voting control, and is barred from being an officer or director of any public company for 10 years.[13][14] If Theranos
Theranos
is acquired or is otherwise liquidated, Holmes would not profit from her ownership until – assuming redemption of certain warrants – over $750 million is returned to defrauded investors and other preferred shareholders. Theranos
Theranos
and Holmes neither admitted nor denied the allegations in the SEC’s complaint.[4] Balwani did not settle.

Contents

1 History 2 Technology and products 3 Corporate affairs

3.1 Location 3.2 Management 3.3 Ownership/valuation 3.4 Investor recapitalization

4 Controversy

4.1 Blood test
Blood test
device inspection 4.2 Testing allegations and case 4.3 Failed lab inspections 4.4 Whistleblower 4.5 Arizona Attorney General 4.6 Partner Fund Management 4.7 SEC fraud charge

5 Bad Blood 6 See also 7 References 8 External links

History[edit] While at Stanford University, Elizabeth Holmes
Elizabeth Holmes
created a wearable patch to adjust the dosage of drug delivery and notify doctors wirelessly of variables in patient's blood.[15] 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.[16] 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".[17][18] In 2004, Theranos
Theranos
was headquartered out of a rented basement located near a strip mall by the Stanford campus.[19] By December 2004, Theranos
Theranos
had more than $6 million from investors with an estimated value of $30 million.[20] The company had about $45 million total fundraising after Series B and Series C funding in 2006.[21] Theranos raised an additional $45 million in 2010 and had an estimated value of $1 billion.[20][22] The company moved to the former headquarters of Facebook
Facebook
in June 2012.[23] During its first 10 years of operation, Theranos
Theranos
was in stealth mode, similar to other Silicon Valley startups, which received criticism from the media and scientific community.[24] The company had significant news coverage starting in September 2013 after profiles in the San Francisco Business Times
San Francisco Business Times
and Wall Street Journal.[16] By 2014, Theranos
Theranos
had raised more than $400 million with an estimated value of $9 billion.[25] In September 2013, Theranos
Theranos
partnered with Walgreens
Walgreens
to offer in-store blood tests at more than 40 locations. Walgreens
Walgreens
announced plans to expand the "wellness centers" across the United States.[26] The company's blood tests were used on drug trial patients of GlaxoSmithKline
GlaxoSmithKline
and Pfizer. Each company stated that there were no ongoing active projects with Theranos
Theranos
in October 2015.[27][28] In November 2016, Walgreen Co. filed suit against Theranos
Theranos
in a federal court in Delaware, for breach of contract. Theranos
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.[29][30] Cleveland Clinic
Cleveland Clinic
announced a partnership with Theranos
Theranos
to test its technology in order to decrease the cost of lab tests.[31] Theranos became the lab-work provider for Pennsylvania insurers, AmeriHealth Caritas and Capital BlueCross, in July 2015.[32][33] In July 2015, the Food and Drug Administration
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.[34][35] Theranos was awarded the 2015 Bioscience Company of the Year by AzBio.[36] In 2016, Forbes
Forbes
revised the estimated net worth of the company to $800 million taking into account the $724 million of capital raised.[1] Theranos
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.[10][37][38][39][37] On January 6, 2017, Theranos
Theranos
announced that it had laid off 41% of its workforce, or approximately 155 people. In January 2017, the company faced lawsuits from several different entities including Walgreens[40][41] and the Arizona Attorney General over blood testing devices.[42]. In August 2017, Theranos
Theranos
announced it had reached a settlement with Walgreens.[43] In December 2017, Fortress Investment Group
Fortress Investment Group
loaned $100 million to Theranos. Theranos
Theranos
had reportedly been on the verge of bankruptcy, with the loan meant to keep the company solvent through 2018.[44][45][46] Technology and products[edit] Theranos
Theranos
claimed to have developed devices to automate and miniaturize blood tests using microscopic blood volumes. Theranos
Theranos
dubbed its blood collection vessels the "nanotainer" and its analysis machine the "Edison."[47][48][49] Its technology has been criticized for not being peer reviewed.[50][51] Theranos
Theranos
claimed to have data verifying the accuracy and reliability of its tests that would be published.[52] In February 2016, Theranos
Theranos
announced that it would permit the Cleveland Clinic
Cleveland Clinic
to complete a validation study of its technology.[53] In March, 2016, the Journal of Clinical Investigation found that the company's blood test results were flagged "outside their normal range 1.6x more often than other testing services", that 68% of lab measurements evaluated "showed significant interservice [sic] variability", and that "lipid panel test results between Theranos
Theranos
and other clinical services" were "nonequivalent".[54] 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.[55][56][57] Corporate affairs[edit] Location[edit] Theranos
Theranos
is headquartered in Palo Alto, California. It had laboratories in Newark, California
California
and Scottsdale, Arizona.[58] Management[edit] Since its incorporation 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.[59] In July 2011, Holmes was introduced to former Secretary of State George Shultz, who joined the Theranos
Theranos
board of directors that same month.[60] Over the next three years, Shultz helped to introduce almost all the outside directors on the "all-star board," which included William Perry
William Perry
(former Secretary of Defense), Henry Kissinger (former Secretary of State), Sam Nunn
Sam Nunn
(former U.S. Senator), Bill Frist (former U.S. Senator and heart-transplant surgeon), Gary Roughead (Admiral, USN, retired), James Mattis
James Mattis
(General, USMC), Richard Kovacevich (former Wells Fargo Chairman
Chairman
and CEO) and Riley Bechtel (chairman of the board and former CEO at Bechtel Group).[60][61][62] The board was criticized for consisting "mainly of directors with diplomatic or military backgrounds."[16] In April 2016, Theranos
Theranos
announced its medical advisory board which included past presidents or board members of the American Association for Clinical Chemistry.[63] Members were invited to review the company's proprietary technologies and advise on the integration into clinical practice.[63] The board included past presidents or board members of the American Association for Clinical Chemistry
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
Special
Surgery and professors, Ann M. Gronowski, Larry J. Kricka, Jack Ladenson, Andy O. Miller and Steven Spitalnik.[64][65] 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.[66][67][68] As of May 2016, the Theranos
Theranos
board of directors were:[69]

Elizabeth Holmes, Founder and CEO Riley Bechtel, former Bechtel Group
Bechtel Group
CEO David Boies, a founder and the chairman of Boies Schiller & Flexner William Foege, former director U.S. Centers for Disease Control and Prevention Richard Kovacevich, former Wells Fargo CEO and chairman James Mattis, retired USMC General and current US Secretary of Defense Fabrizio Bonanni, former executive vice president of Amgen

In December 2016, it was announced the Theranos
Theranos
management team would be restructured with the departing of Riley Bechtel. In January 2017 incoming Secretary of Defense nominee James Mattis
James Mattis
resigned from the Theranos
Theranos
board. As of January 2017, the Theranos
Theranos
board of directors includes:[70]

Elizabeth Holmes, Founder and CEO William Foege, former director U.S. Centers for Disease Control and Prevention Fabrizio Bonanni, former executive vice president of Amgen Daniel Warmenhoven, former NetApp
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.[71] Ownership/valuation[edit] A 2016 article said that the company had been valued in the private market at $9 billion in 2013, soon after its tests had launched. At the time, Holmes was the majority shareholder.[72] In June 2016, Forbes
Forbes
magazine spoke to venture capitalists, analysts and industry experts and concluded that a more realistic value for Theranos
Theranos
is now $800 million. Since Theranos' venture capital investors own preferred shares, they would get paid back before Holmes. This would render Holmes' shares virtually worthless.[1] Investor recapitalization[edit] In May 2017, participating shareholders provided a release of any potential claims against Theranos
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
Elizabeth Holmes
contributed shares to the Company and gave up equity to offset potential dilution to non-participating shareholders.[73] Controversy[edit] Blood test
Blood test
device inspection[edit] The FDA received a formal inquiry to look at Theranos
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.[74] 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".[75] After the inspection, Theranos announced that it would voluntarily suspend its tests apart from the FDA-approved herpes simplex virus (HSV-1) test.[76] Testing allegations and case[edit] In October 2015, The Wall Street Journal
The Wall Street Journal
reported that Theranos
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.[77] Theranos
Theranos
claimed that the allegations were "factually and scientifically erroneous and grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents".[78][79] Walgreens
Walgreens
suspended plans to expand blood-testing centers in their stores following the report.[80][81] At that time, the Cleveland Clinic
Cleveland Clinic
announced that it would work to verify Theranos technology.[82] Theranos
Theranos
is under criminal investigation by federal prosecutors and the Securities and Exchange Commission
Securities and Exchange Commission
for allegedly misleading investors and government officials about its technology.[83] The case is considered "extremely unusual" by a former assistant U.S. attorney for the Justice Department.[84] The U.S. House of Representatives Committee on Energy and Commerce requested information on what Theranos
Theranos
was doing to correct its testing inaccuracies and adherence to federal guidelines in June 2016.[85][86] On April 21, 2017, the Wall Street Journal
Wall Street Journal
reported that an investor had alleged that Theranos
Theranos
Inc. had misled company directors about its practices concerning laboratory testing. According to a lawsuit filed by the investor, Theranos
Theranos
had used a shell company to secretly buy lab equipment to run fake demonstrations with.[87]. The case was settled on May 1, 2017, dismissing all claims by PFM against Theranos.[88] Failed lab inspections[edit] The Arizona Department of Health Services reported issues with the company's Scottsdale lab meeting regulations in October 2015.[89] In January 2016, the Centers for Medicare and Medicaid Services
Centers for Medicare and Medicaid Services
(CMS) sent a letter to Theranos
Theranos
based on an inspection of its Newark, California
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.[90] 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.[91] The company did not receive the sanctions until July.[92] Walgreens
Walgreens
and Capital BlueCross announced a suspension of Theranos blood tests from the Newark lab.[93] In May 2016, Theranos
Theranos
announced that it had voided two years of results from its Edison device.[94] The company announced that about 1 percent of test results had been voided or corrected from its proprietary machines in June 2016.[95] In July 2016, Theranos
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.[9] Theranos
Theranos
announced plans to appeal the decision by regulators to revoke its license to operate a lab in California
California
and other sanctions.[96] 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.[97] 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.[98][99] In January 2017, the Wall Street Journal
Wall Street Journal
reported Theranos
Theranos
is closing down the last remaining blood-testing facility after the lab reportedly failed a second major U.S. regulatory inspection.[100][101] Whistleblower[edit] In November, 2016, the Wall Street Journal
Wall Street Journal
ran a story about Tyler Shultz, the grandson of former Secretary of State and one-time Theranos
Theranos
director George P. Shultz. The younger Shultz was a Theranos employee 2013–14 and, it appears, a critical whistleblower regarding defects in Theranos' technology. The elder Shultz 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
Sam Nunn
(D-GA). The Journal reported: "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 Shultz aggressively on behalf of the company. While causing significant family and financial strains, in the November 2016 article Tyler Shultz 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.[72] Arizona Attorney General[edit] In April 2017, Theranos
Theranos
reached a settlement with the state of Arizona over alleged false advertisement and inaccurate blood testing, agreeing 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.[102][103][104][105] Partner Fund Management[edit] In court documents unsealed on April 18, 2017, lawyers for Partner Investments LP and two other funds, with combined stakes totaling more than $96 million in Theranos
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
Theranos
officials said the funds had mischaracterized the exchange offer, which was discussed before the suit was filed.[106] On May 1, 2017, Theranos
Theranos
announced that it had reached an undisclosed settlement with Partner Fund Management LP. Theranos
Theranos
General Counsel David Taylor stated: “ Theranos
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.”[107] SEC fraud charge[edit] In March 2018 the US Securities and Exchange Commission
Securities and Exchange Commission
charged Theranos, its CEO Elizabeth Holmes
Elizabeth Holmes
and former president Ramesh 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."[108][109] 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.[110] Balwani did not settle with the SEC.[111] Bad Blood[edit] The Wall Street Journal
The Wall Street Journal
investigative reporter John Carreyrou was responsible for uncovering and exposing "that the company was, in effect, a sham".[112] For this he received the 67th annual George Polk Awards for Financial Reporting (2015). He will be publishing a book-length treatment in 2018 titled Bad Blood, and a film version is in the works starring Jennifer Lawrence
Jennifer Lawrence
as Elizabeth Holmes, to be directed by Adam McKay.[113] See also[edit]

Hematology Medical device

References[edit]

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Forbes
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Theranos
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Theranos
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External links[edit]

Official website " Elizabeth Holmes
Elizabeth Holmes
on Her Billion-Dollar Health Care Idea", Charlie Rose via YouTube, June 3, 2015. Tobak, Steve, "After the Theranos
Theranos
Mess, Can We Finally Quit Idolizing Entrepreneurs?" (Commentary), Fortune magazine. May 27, 2016. "Theranos, CEO Holmes, and Former President Balwani Charged With Massive Fraud". Press Release. The Securities and Exchange Commission. Retrieved 14

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