Theranos

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Theranos
Private
Industry Health care
Founded 2003; 15 years ago (2003)
Founder Elizabeth Holmes
Headquarters Palo Alto, California, United States
Key people
Elizabeth Holmes (Chairman), David Taylor (CEO)
Products Blood tests
Services Medical tests
Total equity Decrease$800 million (2016)[1]
Number of employees
~24
Website www.theranos.com
Footnotes / references
[2]

Theranos (/ˈθɛrəns/) is a privately held health technology company known for its false claims to have devised revolutionary blood tests using very small amounts of blood.[3][4]

Theranos was lauded as a major challenger to existing companies before it was revealed that the company had lied about its core capabilities.[5][6] Founded in 2003 by 19-year old Elizabeth Holmes,[7] Theranos raised more than US$700 million from venture capitalists and private investors,[8] resulting in a $10 billion valuation at its peak in 2013 and 2014.[9][10][11] Investors and the media hyped Theranos as a breakthrough in the large blood testing market, where the US diagnostic-lab industry posts annual sales of over $70 billion. Theranos claimed its technology was revolutionary for a number of reasons. At the time, Theranos said 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.

There was a turning point in October 2015, when investigative reporter John Carreyrou of The Wall Street Journal questioned the validity of its technology. Since then, 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, patients, and others.[12] By June 2016, it was estimated that Holmes' personal net worth had dropped from $4.5 billion to virtually nothing.[1] The company was near bankruptcy until it received a $100 million investment from Fortress Investment Group in 2017.[13] By 2018, the company was again close to going bankrupt.

In July 2016, Theranos received sanctions from the Centers for Medicare and Medicaid Services (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.[14] Theranos announced it would close its laboratory operations and wellness centers to work on miniature medical testing machines.[15] In April 2017, Theranos said it had reached a settlement agreement with CMS.[16]

Following the CMS sanctions, Walgreens, one of the largest pharmacy chains in the US, 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.[citation needed]

On March 14, 2018, Holmes, former Theranos President Ramesh "Sunny" Balwani and Theranos were charged with "massive fraud" by the U.S. Securities and Exchange Commission.[17] One section of the complaint alleged that Holmes claimed in 2014 that the company had annual revenues of $100 million, a thousand times more than the actual figure of $100,000.[18] 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 10 years.[19][20] According to the agreement, if Theranos is acquired or is otherwise liquidated, Holmes will not profit from her ownership until more than $750 million is returned to investors and other preferred shareholders. Theranos and Holmes neither admitted nor denied the allegations in the SEC’s complaint.[8] Balwani did not settle.[21]

On June 15, 2018, the United States Attorney for the Northern District of California announced the indictment of Holmes on wire fraud and conspiracy charges. Holmes stepped down as CEO but remained as chairman. Balwani was also indicted on the same charges.[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 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,[10][27][28] which Holmes changed after deciding that too many people were dubious about the word "cure".[10]

Valuation[edit]

Theranos raised millions of dollars in its first years. In 2004, Theranos was based in a rented basement located near the Stanford campus.[29] By December 2004 the company had more than $6 million from investors at a valuation of $30 million.[30] The company had about $45 million total fundraising after Series B and Series C funding in 2006.[31] Theranos raised an additional $45 million in 2010 at a valuation of $1 billion.[30][32] The company moved to the former headquarters of Facebook in June 2012.[33][34] 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.[35] In 2016, Forbes revised the estimated net worth of the company to $800 million taking into account the $724 million of capital raised.[1]

Partnerships[edit]

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.[36] 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.[37][38] 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.[39][40]

Cleveland Clinic announced a partnership with Theranos to test its technology in order to decrease the cost of lab tests.[41] Theranos became the lab-work provider for Pennsylvania insurers, AmeriHealth Caritas and Capital BlueCross, in July 2015.[42][43]

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.[44][45] Theranos was awarded the 2015 Bioscience Company of the Year by AzBio.[46]

Controversy[edit]

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.[15][47][48][49][47] On January 6, 2017, 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[50][51] and the Arizona Attorney General.[52]. In August 2017, Theranos announced it had reached a settlement with Walgreens.[53]

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.[54][55][56] 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.[2][57]

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."[58][59][60] The technology has been criticized for not being peer reviewed.[61][62] Theranos claimed to have data verifying the accuracy and reliability of its tests that would be published.[63] In February 2016, Theranos announced that it would permit the Cleveland Clinic to complete a validation study of its technology.[64] 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 and other clinical services" were "nonequivalent".[65] In August 2016, the company introduced a new robotic, capillary blood testing unit named miniLab to the American Association for Clinical Chemistry, but did not present any data supporting the claimed abilities of the device.[66][67][68]

Corporate affairs[edit]

Location[edit]

Theranos is headquartered in Palo Alto, California. It previously had laboratories in Newark, California and Scottsdale, Arizona.[69]

Management[edit]

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 18 years her senior whom Holmes had met during high school, joined the company as its president and chief operating officer in 2009.[70] In July 2011, Holmes was introduced to former Secretary of State George Shultz, who joined the Theranos board of directors that month.[71] 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).[71][72][73] 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.[74] Members were invited to review the company's proprietary technologies and advise on the integration into clinical practice.[74] 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.[75][76]

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.[77][78][79]

In May 2016 members of the Theranos board of directors were:[80]

  • Elizabeth Holmes, founder and CEO
  • Riley Bechtel, former Bechtel Group CEO
  • David Boies, a founder and the chairman of Boies Schiller & Flexner
  • William Foege, former director CDC
  • Richard Kovacevich, former Wells Fargo CEO and chairman
  • James Mattis, later US Secretary of Defense
  • Fabrizio Bonanni, former executive vice president of Amgen

In December 2016, it was announced the Theranos management team would be restructured with the departing of Riley Bechtel. In January 2017 incoming US Secretary of Defense nominee James Mattis resigned from the Theranos board. In January 2017 the Theranos board of directors included:[81] 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.[82]

Investor recapitalization[edit]

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.[83]

Downfall[edit]

Blood test device inspection[edit]

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.[84] 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".[85] After the inspection, Theranos announced that it would voluntarily suspend its tests apart from the FDA-approved herpes simplex virus (HSV-1) test.[86]

Testing allegations and case[edit]

In October 2015, 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.[87] Theranos claimed that the allegations were "factually and scientifically erroneous and grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents".[88][89] Walgreens suspended plans to expand blood-testing centers in their stores following the report.[90][91] At that time, the Cleveland Clinic announced that it would work to verify Theranos technology.[92] 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.[3]

Theranos is under criminal investigation by federal prosecutors and the SEC for allegedly misleading investors and government officials about its technology.[93] The case is considered "extremely unusual" by a former assistant U.S. attorney for the Justice Department.[94] 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.[95][96] On April 21, 2017, the Wall Street Journal reported that an investor had alleged that Theranos Inc. had misled company directors about its practices concerning laboratory testing. According to a lawsuit filed by the investor, Theranos had used a shell company to secretly buy lab equipment to run fake demonstrations.[97]. The case was settled on May 1, 2017.[98]

Failed lab inspections[edit]

The Arizona Department of Health Services reported issues with the company's Scottsdale lab meeting regulations in October 2015.[99] 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.[100] 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.[101] The company did not receive the sanctions until July.[102] Walgreens and Capital BlueCross announced a suspension of Theranos blood tests from the Newark lab.[103] In May 2016, Theranos announced that it had voided two years of results from its Edison device.[104] The company announced that about 1 percent of test results had been voided or corrected from its proprietary machines in June 2016.[105]

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.[14] Theranos announced plans to appeal the decision by regulators to revoke its license to operate a lab in California and other sanctions.[106] 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.[107]

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.[108][109]

In January 2017, the Wall Street Journal reported Theranos was closing the last remaining blood-testing facility after the lab failed a second major U.S. regulatory inspection.[110][111]

Whistleblower[edit]

In November, 2016, the Wall Street Journal ran a story about Tyler Shultz, the grandson of former Secretary of State and one-time 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 (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.[112]

Arizona Attorney General[edit]

In April 2017, Theranos reached a settlement 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.[113][114][115][116]

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 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.[117] 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.”[118]

SEC fraud charge[edit]

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."[119][120] 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.[121] Balwani did not settle with the SEC.[122]

Indictments[edit]

On June 15, 2018 Holmes and Balwani were indicted on multiple counts of wire fraud and conspiracy to commit wire fraud. Both investors and doctors and patients were alleged to have been defrauded. It is alleged that 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.[123][124]

Loss by investors[edit]

In May 2018 John Carreyrou reported that American business and government leaders lost more than $600 million by privately investing in Theranos.[125] 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).[14]

Bad Blood[edit]

Wall Street Journal investigative reporter John Carreyrou was responsible for uncovering and exposing "that the company was, in effect, a sham".[126] For this he received the 67th annual George Polk Awards for Financial Reporting (2015). He published a book-length treatment in May 2018 titled Bad Blood: Secrets and Lies in a Silicon Valley Startup.[127] A film version is in the works starring Jennifer Lawrence as Elizabeth Holmes and directed by Adam McKay.[128]

See also[edit]

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