Founded in 2003 by then 19-year-old Elizabeth Holmes, Theranos raised more than US$700 million from venture capitalists and private investors, resulting in a $9 billion valuation at its peak in 2013 and 2014.
The company faced a string of legal and commercial challenges from medical authorities, investors, the U.S. Securities and Exchange Commission (SEC), the Centers for Medicare and Medicaid Services (CMS), state attorneys general, former business partners, patients, and others.
[12] 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.
[14] Holmes dropped out of Stanford in 2003 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".
[29][30] The same month, 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.
[34][35] In May 2015, University of Toronto Professor Eleftherios Diamandis analyzed Theranos technology and concluded that "most of the company's claims are exaggerated".
[28] Theranos fought back against the Journal's investigation, sending lawyers after sources in the story, including Shultz, in an effort to stop them from providing information to the press.
[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".
[55] In January 2016, the Centers for Medicare and Medicaid Services (CMS) sent a letter to Theranos based on a 2015 inspection of its Newark, California lab, reporting that the facility caused "immediate jeopardy to patient health and safety" due to a test to determine the correct dose of the blood-thinning drug warfarin.
[56][57] Walgreens subsequently announced a suspension of Theranos blood tests from the Newark lab and immediately paused wellness services in Palo Alto.
[59][60] The company came under criminal investigation by federal prosecutors and the SEC for allegedly misleading investors and government officials about its technology.
[61] 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.
[62][63] In July 2016, Theranos announced that the CMS had revoked its Clinical Laboratory Improvement Amendments (CLIA) certificate and issued sanctions prohibiting its owners and operators from owning or operating a clinical laboratory for two years, suspension of approval to receive Medicare and Medicaid payments, and a civil monetary penalty.
[69][70] Theranos announced that it would close its laboratory operations and wellness centers and lay off about 40% of its workforce to work on miniature medical testing machines in October 2016.
[71][72][73][74] In January 2017, Theranos announced that it had laid off a further 41% 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.
[80] The suit also alleged that Theranos had misled company directors about its practices concerning laboratory testing and that it had secretly bought lab equipment to run fake demonstrations.
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.
[96] 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 were fruitless.
The specific evidence in question is the history of internal testing, including accuracy and failure rates of Theranos's blood-testing systems.
[119] 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.
[124][125] By 2017 Theranos was headquartered at 1701 Page Mill Road, Palo Alto, California, paying a $1 million per month lease for the Stanford Research Park building.
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.
[133] The board included members with relevant biomedical expertise such as past president of the American Association for Clinical Chemistry Susan A. Evans; William Foege, former director of the 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.
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.
[144][146] The company had significant news coverage starting in September 2013 after profiles in the San Francisco Business Times and The Wall Street Journal.
[151] 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.
[97] John Carreyrou, a Wall Street Journal journalist whose work exposed Theranos, published a book-length treatment in May 2018 titled Bad Blood: Secrets and Lies in a Silicon Valley Startup.
[155] A film version was reportedly scheduled for release in 2020, starring Jennifer Lawrence as Elizabeth Holmes, written by Vanessa Taylor and directed by Adam McKay.
[160] A miniseries with the same name, based on the eponymous podcast, premiered on Hulu in the US, Star+ in Latin America and Disney+ internationally in March 2022, with Amanda Seyfried as Holmes.
Directed by Alex Gibney, it made its debut at the Sundance Film Festival and was released to the general public in March 2019 on HBO platforms.