While two physicians have subsequently been named to the board, and published reference has been made to a "deep medical advisory group,"^[1] as of January 2016, no scientific or medical advisory board information appears in the company's public information. In April 2016, Theranos announced its medical advisory board which included past presidents or board members of the American Association for Clinical Chemistry.^[2]

Ramesh "Sunny" Balwani left Theranos in May 2016.^[1]

As of May 2016, the Theranos board of directors are:^[1]

• 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

While other aspects of its operations remain secretive,^[1] Theranos corporate governance has been the subject of various press disclosures and subsequent news reports.

[...]

[...]

[...]

[...]

On June 12, 2016, Walgreens announced it would no longer offer Theranos services at any of its stores and would sever its relationship with Theranos.^[1]

[...]

Subsequently, a key metric of Theranos valuation was notably called into question when Walgreens suspended further expansion of Theranos Wellness Centers.^[2]

Walgreens suspended its plans to add Theranos' testing services in its stores, and later removed Theranos' testing from all existing locations.^[1][2]

[...]

Walgreens suspended plans to expand blood-testing centers in their stores following the report.^[3][4] At that time, the Cleveland Clinic announced that it would work to verify Theranos technology.^[5]

[...]

Three days later, Walgreens, which had partnered with Theranos to provide its blood testing services in stores, ceased all testing at a Palo Alto location, and ordered the company to process all of its other tests from Walgreens locations at its Arizona laboratory instead of the California lab.^[6]

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.^[1] The Arizona Department of Health Services reported issues in the company's other laboratory.^[2] Several clinical pathologists and other medical experts also expressed skepticism about Theranos's technology. A week later, the Food and Drug Administration (FDA) stated that the company's miniature blood containers were unapproved for any test other than the herpes test. Subsequently, Theranos was ordered to limit the use of its proprietary technology to only one of the 200 tests offered by the company.^[3][4]

The Food and Drug Administration received a formal inquiry to look at Theranos blood test devices by the Department of Defense in 2012 before the devices were commercially available and did not require FDA approval.^[5] 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."^[6] After the inspection, Theranos announced that it would voluntarily suspended its tests apart from the FDA approved herpes simplex virus (HSV-1) test.^[7]

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.^[8]

Subsequent articles have called into question previous statements by Theranos regarding the nature and source of its income.^[9] 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.^[10] 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.^[11]

[...]

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.^[5]

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.^[1]

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.” ^[1]

[...]

On August 25, 2016, Theranos announced its plans to appeal the decision by regulators to revoke its license to operate a lab in California, among and other penalties sanctions, because of unsafe practices.^[2] On August 31, 2016, Theranos The company withdrew its request for emergency clearance of a Zika virus blood test due to a finding by federal inspectors of after a lack of essential safeguards during the testing process was found by federal inspectors in August 2016.^[3][1] On October 5, 2016, Theranos announced that it would close its laboratory operations, shutter its wellness centers and lay off around about 40 percent of its work force, while henceforth focusing on an initiative to create to work on miniature medical testing machines in October 2016.^[4][5]

[...]

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.^[1] Theranos has claimed to have partnerships with GlaxoSmithKline and Pfizer, which both companies have denied.^[2] 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.^[3]

Although Theranos was valued at $9 billion by some of its investors, which would have valued Holmes's stake at $4.6 billion, The Economist noted that startups of this nature can wind up being valued as a "fantasy" rather than based upon present reality.^[4] [...]

On In October 16, 2015, The Wall Street Journal, quoting many unnamed current and former employees, reported that Theranos was using traditional blood testing machines, such as Siemens, to run its tests and that Theranos's flagship the company's Edison testing device machines might provide inaccurate results.^[1] 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).^[1] 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.^[2] Theranos attacked the Journal, but did not refute any of the allegations. Theranos claimed that the allegations were "factually and scientifically erroneous and grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents."^[3][4]

Famed litigator David Boies was hired by Theranos after it failed a federal laboratory inspection.^[1] The company’s general counsel is a former partner at Boies Schiller and Theranos had hired Boies in the past.^[1] Theranos attracted controversy however, by also granting Boies a seat on the board of directors.^[1] 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.^[1]

Walgreens and Capital BlueCross announced a suspension of Theranos blood tests from the Newark laboratory.^[1] In May 2016, Theranos announced that it had withdrawn all blood test results run on its Edison machine from 2014 and 2015.^[2]

[...]

In 2007, Theranos filed suit in Santa Clara, California, accusing former employees of breaching company secrecy.^[3] 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.^[4] Another case, in Washington, D.C. against McDermott Will & Emery itself, was dismissed in August 2013.^[5][6]

[...]

Theranos is facing class-action complaints alleging misrepresentation of its testing services.^[7]

The Arizona Department of Health Services reported issues with the company's Scottsdale, Arizona laboratory meeting regulations in October 2015.^[1]

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.^[2] The inspection report indicates that 29% of the quality control checks performed on the Edison devices produced results outside an acceptable range.^[3] 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."^[3]

On In January 25, 2016, the Centers for Medicare and Medicaid Services (CMS) sent a strongly-worded letter to Theranos following based on an inspection of the company's its Newark, California laboratory, conducted in November in the fall of 2015. "[I]t was determined that the deficient practices of the laboratory pose immediate jeopardy to patient health and safety," the letter noted.^[4] CMS gave Theranos a deadline of 10 business days to prove that the laboratory was complying with hematology-related and other lab requirements. The inspection found 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.^[5]

Theranos is an American privately held consumer health-technology health technology company based in Palo Alto, California.^[1] It is under criminal investigation by federal prosecutors and the Securities and Exchange Commission.^[2]

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,^[3] utilizing microfluidics technology.^[4] The company has been recognized for its fingerstick and microfluidics technology. It was founded in 2003 by Elizabeth Holmes at the age of 19.^[3] By the summer of 2014, its founders Theranos had raised over more than $400 million from investors, valuing the company at in funding with an estimated value of $9 billion.^[5][6]

[...]

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.^[7] 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.”^[8]

Theranos is currently under criminal investigation by federal prosecutors and the Securities and Exchange Commission.^[2]

Theranos is under criminal investigation by federal prosecutors and the Securities and Exchange Commission for allegedly misleading investors and government officials about its technology.^[2] The case is considered "extremely unusual" by a former assistant U.S. attorney for the Justice Department.^[9] 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.^[7][8]

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. ^[10]

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."^[11]

In July 2016, Theranos announced that it had received notice from the CMS regarding the revocation of had revoked its CLIA certificate. Sanctions include a prohibition of the 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. 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.” Theranos announced it was discontinuing The company discontinued testing at its Newark location while attempting to resolve the issues identified.^[1]