|Headquarters||Palo Alto, California, United States|
Theranos is an American privately held health-technology and medical-laboratory-services company based in Palo Alto, California. It is under criminal investigation by federal prosecutors and the Securities and Exchange Commission.
Theranos developed a blood-testing device named Edison. The company said the device uses a few drops of blood obtained via a finger-stick, rather than vials of blood obtained via traditional venipuncture, utilizing microfluidics technology. By the summer of 2014, its founders had raised over $400 million from investors, valuing the company at $9 billion.
In October 2015, controversy surrounding the company's blood testing process arose after a report in The Wall Street Journal raised concerns about the accuracy of its Edison device. An independent U.S. government review by the Centers for Medicare and Medicaid Services (CMS) reported inaccurate testing results and multiple deficiencies in sample handling during a recent inspection.
On July 7, 2016, Theranos announced that it had received notice from the Centers for Medicare & Medicaid Services (CMS) regarding the revocation of its CLIA certificate. Sanctions include a prohibition of the owners and operators from owning or operating a lab for two years and a civil monetary penalty.
On October 5, 2016, Theranos announced that it would close its laboratory operations, shutter its wellness centers and lay off around 40 percent of its work force, while henceforth focusing on an initiative to create miniature medical testing machines.
- 1 History
- 2 Corporate affairs
- 3 Controversies
- 4 Litigation
- 5 See also
- 6 References
- 7 External links
While at Stanford University, Elizabeth Holmes created a wearable patch to adjust the dosage of drug delivery and notify doctors wirelessly of variables in patient's blood. 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. 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".
In 2004, Theranos was headquartered out of a rented basement located near a strip mall by the Stanford campus. By December 2004, Theranos had more than $6 million from investors with an estimated value of $30 million. The company had about $45 million total fundraising after Series B and Series C funding in 2006. Theranos raised an additional $45 million in 2010 and had an estimated value of $1 billion.
The company moved to the former headquarters of Facebook in June 2012. During its first 10 years of operation, Theranos was in stealth mode, similar to other Silicon Valley startups, which received criticism from the media and scientific community. The company had significant news coverage starting in September 2013 after profiles in the San Francisco Business Times and Wall Street Journal. By 2014, Theranos had raised more than $400 million with an estimated value of $9 billion. 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. Theranos was awarded the 2015 Bioscience Company of the Year by AzBio.
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. The company's blood tests were used on drug trial patients of GlaxoSmithKline and Pfizer. Each company stated that there were no ongoing active projects with Theranos in October 2015.
Cleveland Clinic announced a partnership with Theranos to test its technology in order to decrease the cost of lab tests. Theranos became the lab-work provider for Pennsylvania insurers, AmeriHealth Caritas and Capital BlueCross, in July 2015. Walgreens suspended its plans to add Theranos' testing services in its stores, and later removed Theranos' testing from all existing locations.
During its first decade of operation, the company developed devices to automate and miniaturize blood tests using microscopic blood volumes. Theranos was best known for its "nanotainer" fingerstick, which draws a microliter sample of blood from the capillaries in a patient's hand. Theranos claimed to have data verifying the accuracy and reliability of its tests that would be published.
Its technology has been criticized for not being scientifically peer reviewed. In February 2016, Theranos announced that it would permit the Cleveland Clinic to complete a validation study of its technology. The Journal of Clinical Investigation found that the company's blood test results were "much more in line with the others than they are out of line" in March 2016. In May 2016, Theranos announced that it had voided two years of results from its Edison device. The company announced that about 1 percent of test results had been voided or corrected from its proprietary machines in June 2016. While the company was expected to present data about its Edison technology to the American Association for Clinical Chemistry in August 2016, it instead introduced a new robotic, capillary blood testing unit named miniLab. The company did not address any questions or present any data related to the previous test results or the Edison device.
In August Theranos announced, and then later withdrew its request, for emergency clearance of a new Zika-virus blood test. The Wall Street Journal reported that according to unnamed sources, federal regulators had found that the company didn’t follow proper patient safeguards in a study for the test. Theranos’s vice president of regulatory, quality and clinical affairs Dave Wurtz stated: “We hope that our decision to withdraw the Zika submission voluntarily is further evidence of our commitment to engage positively with the agency.” 
Since its foundation in 2003, Holmes has been the company's chief executive officer. She recruited Channing Robertson, a chemical-engineering professor at Stanford, to be a technical advisor and the company's first board member during its early years. Sunny Balwani, a software engineer Holmes had met during high school, joined the company as its President and chief operating officer in 2009. In July 2011, Holmes was introduced to former Secretary of State George Shultz, who joined the Theranos board of directors that same month. 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). The board was criticized for consisting "mainly of directors with diplomatic or military backgrounds."
In April 2016, Theranos announced its medical advisory board which included past presidents or board members of the American Association for Clinical Chemistry. Members were invited to review the company's proprietary technologies and advise on the integration into clinical practice. The board included past presidents or board members of the American Association for Clinical Chemistry such as Susan A. Evans, William Foege, former director U.S. Centers for Disease Control and Prevention, David Helfet, director of the Orthopedic Trauma Service at the Hospital for Special Surgery and professors, Ann M. Gronowski, Larry J. Kricka, Jack Ladenson, Andy O. Miller and Steven Spitalnik.
Balwani left his position as President and COO in May 2016. At that time, the company announced its new board members, Fabrizio Bonanni, Richard Kovacevich and William Foege, who would help to publicly introduce its technologies. The following people joined Theranos as directors: Fabrizio Bonanni, former executive vice president of Amgen; Richard Kovacevich; and William Foege, former director of the Centers for Disease Control and Prevention.
As of May 2016, the Theranos board of directors are:
- 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 U.S. Centers for Disease Control and Prevention
- Richard Kovacevich, former Wells Fargo CEO and chairman
- James Mattis, retired USMC General
- Fabrizio Bonanni, former executive vice president of Amgen
On October 16, 2015, The Wall Street Journal, quoting many unnamed current and former employees, reported that Theranos's flagship Edison testing device might provide inaccurate results. The alleged discrepancies in Theranos' proficiency testing and reporting to regulators led to a formal complaint filed with the New York State Department of Health that was forwarded to the Centers of Medicare and Medicaid Services (CMS). Moreover, the bulk of the blood tests being performed by Theranos were reported to be conducted on traditional machines of competitors' companies, such as Siemens, rather than its own Edison machines. Theranos attacked the Journal, but did not refute any of the allegations.
Wired asserted that the company may have succumbed to Silicon Valley pressures of trying to "spin hype into startup gold" and promising more than they could deliver. Theranos has claimed to have partnerships with GlaxoSmithKline and Pfizer, which both companies have denied. Theranos also claimed the successful venture capital firm Draper Fisher Jurvetson had invested in them, but company principal Steve Jurvetson clarified that it had provided the company's first $500,000 seed investment and nothing more.
On October 28, 2015, the Food and Drug Administration (FDA) also reported major shortcomings in the company's practices and ordered Theranos to stop using its Edison device, which it had neither tested for accuracy nor approved, contrary to the company's previous claims. Theranos was ordered to limit its use of Edison to one of the 200 tests it offered. The Arizona Department of Health Services reported issues in the company's other laboratory.
Theranos asserted that the reports were “factually and scientifically erroneous and grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents.” Subsequently, a key metric of Theranos valuation was notably called into question when Walgreens suspended further expansion of Theranos Wellness Centers. Additionally, after an FDA inspection, Theranos reported it had voluntarily suspended use of its flagship micro or low volume blood testing technique except for Herpes virus testing.
Subsequent articles have called into question previous statements by Theranos regarding the nature and source of its income. Though Theranos has often claimed to have FDA approval for its laboratory tests, FDA inspection reports from 2014 and 2015 suggest that the government has noted significant concerns. On August 31, 2016, Theranos withdrew its Zika virus test due to a finding by federal inspectors of a lack of essential safeguards during the testing process.
Centers for Medicare and Medicaid Services Certification
A report from the Centers for Medicare and Medicaid Services (CMS) released in 2016 detailed a number of deficiencies with Theranos procedures and testing results. The inspection report indicates that 29% of the quality control checks performed on the Edison devices produced results outside an acceptable range. In addition, federal inspectors also cited Theranos for "doing tests with unqualified personnel, for long delays in notifying patients of flawed test results and for storing blood samples at the wrong temperatures."
On January 27, 2016, CMS said that Theranos's Newark, California location posed "immediate jeopardy to patient safety," and required a response in 10 days or it would pull its certification of the lab. It was later revealed that the "immediate jeopardy" specifically related to Theranos’s test for the clotting ability of blood, which is used to help determine the correct dose of the blood-thinning drug warfarin.
Theranos submitted a plan to correct the problems in February 2016. However, in March 2016, CMS regulators said that the company’s response "does not constitute a credible allegation of compliance and acceptable evidence of correction for the deficiencies cited." The regulators "proposed a series of sanctions against the company, including the revocation of the company’s certification for its California laboratory, its primary operation, and suspension of its eligibility to receive payments under the Medicare insurance program." The company responded on April 1, but said it had not received notice of the regulators’ final decision as of April 13, 2016.
On July 7, 2016, Theranos announced that it had received notice from the CMS regarding the revocation of its CLIA certificate. Sanctions include a prohibition of the 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. Theranos' CEO Elizabeth Holmes responded in a statement: “We accept full responsibility for the issues at our laboratory in Newark, California, and have already worked to undertake comprehensive remedial actions. Those actions include shutting down and subsequently rebuilding the Newark lab from the ground up, rebuilding quality systems, adding highly experienced leadership, personnel and experts, and implementing enhanced quality and training procedures. While we are disappointed by CMS’ decision, we take these matters very seriously and are committed to fully resolving all outstanding issues with CMS and to demonstrating our dedication to the highest standards of quality and compliance.”
In a later statement on its website replying to the CMS on July 8, 2016 Theranos announced it was discontinuing testing at its Newark location while attempting to resolve issues identified. The company further stated “The clinical lab is just one of Theranos’ many opportunities to provide access to high-integrity, affordable and actionable health care information, and the company will continue to carry out its mission under the leadership of its founder and CEO, Elizabeth Holmes”.
On August 25, 2016, Theranos announced that it plans to appeal the CMS sanctions.
Board of directors appointment of David Boies
Famed litigator David Boies was hired by Theranos after it failed a federal laboratory inspection. The company’s general counsel is a former partner at Boies Schiller and Theranos had hired Boies in the past. Theranos attracted controversy, however by also granting Boies a seat on the board of directors. While the 2013 adopted high-vote stock structure gives Holmes total control of the company, business ethics insiders, reporting to the New York Times, argued that, while it has been done before, having Boies serve both on the board and as the company’s attorney would be difficult as he would have to represent both the Company (as lawyer) and the Investors (as a Director), and that this could in some circumstances result in making a choice between the two.
On December 2, 2015, The Washington Post reported that the exploration of a partnership with the US military had led to issues being found with the Edison device and a request that the FDA investigate. This request was denied by United States Marine Corps General James Mattis after Holmes's intervention. After retiring, Mattis joined the board of directors of Theranos.
U.S. House of Representatives Committee Investigation
It was reported on July 1, 2016, that a U.S. House of Representatives committee investigation was being undertaken into Theranos' past practices. The Committee on Energy and Commerce requested information on what Theranos was doing to correct its testing inaccuracies and adherence to federal guidelines. In the letter sent to founder Elizabeth Holmes, a response was requested by July 14. Theranos said in a statement that it looked forward to responding to the inquiry with an explanation of its improvements, including “new operational leadership, best practices in our laboratories, continuing and constructive engagement with our regulators and ongoing communications with physicians and our patients.”
In 2007, Theranos filed suit in Santa Clara, California, accusing former employees of breaching company secrecy. In 2011 the company filed suit against Fuisz Pharma LLC, accusing them of stealing Theranos' patent files from McDermott Will & Emery. The suit was settled in 2014. Another case, in Washington, D.C. against McDermott Will & Emery itself, was dismissed in August 2013.
Theranos is currently under criminal investigation by federal prosecutors and the Securities and Exchange Commission.
Theranos is facing class-action complaints alleging misrepresentation of its testing services.
On August 25, 2016, the company said it plans to appeal the decision by regulators to revoke its license to operate a lab in California, among other penalties, because of unsafe practices. 
A suit accusing Theranos of securities fraud was filed in October, 2016 by Partner Fund Management, which invested $96.1 million in the company in February 2014. The suit demands return of investment and damages. The company released a statement asserting "The suit is without merit, the assertions are baseless, and the plaintiff is engaging in revisionist history."
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