Healthcare Providers and Services
Company Overview of Theranos, Inc.
Theranos, Inc. operates clinical laboratories in Arizona, California, and Pennsylvania. The company specializes in the areas of oncology, pediatrics, and geriatrics. It also designs, develops, and manufactures testing products in the United States. Theranos, Inc. was founded in 2003 and is based in Palo Alto, California.
1701 Page Mill Road
Palo Alto, CA 94304
Founded in 2003
Key Executives for Theranos, Inc.
Founder, Chairman, Co-Chairman of Scientific & Medical Advisory Board and Chief Executive Officer
Vice President of Regulatory & Quality
Compensation as of Fiscal Year 2016.
Theranos, Inc. Key Developments
Theranos, Inc. Announces Executive Appointments
Jul 21 16
Theranos, Inc. announced the appointment of two new executives to lead the company's regulatory, quality and compliance efforts. Both are reporting to Theranos CEO Elizabeth Holmes. Dave Wurtz, who has nearly two decades experience in U.S. and international regulated industries, including the life sciences industry, was named vice president, regulatory and quality, and Daniel Guggenheim, a lawyer with deep background and leadership in health care compliance and regulations, was named chief compliance officer. Meanwhile, the Theranos Board of Directors has created a Compliance and Quality Committee. It will oversee and advise the board and the company's executive leadership on regulatory compliance and quality systems obligations. Dr. Fabrizio Bonanni, who joined the Board of Directors in May, will chair the committee. The executive-level appointments of Wurtz and Guggenheim are effective immediately. Wurtz will be leading the strategy and implementation of Theranos' pre- and post-market regulatory activities, including obtaining FDA clearances and approvals and marketing of new products and managing the regulatory affairs, medical device quality systems and clinical affairs teams. He also will provide regulatory expertise to cross-functional teams for the development of new products. Wurtz previously served as senior director of regulatory, quality and compliance at ThermoFisher Scientific. He managed multiple FDA inspections and was responsible for all pre- and post- market regulatory activities worldwide. He formerly served as quality group manager, overseeing compliance with FDA and other regulatory requirements, at Beckman Coulter Inc. Wurtz also worked at Osmetech and G.D. Searle, developing and managing the clinical trial program and monitoring compliance. Guggenheim, as chief compliance officer, will lead day-to-day implementation and oversight of the company's compliance program, with an emphasis on maintaining and enhancing policies, procedures, training and monitoring mechanisms to promote compliance with all applicable state and federal regulations. Guggenheim has been assistant general counsel, regulatory law, at McKesson Corp. He was the company's chief regulatory and compliance counsel and senior counsel for its pharmaceutical division, addressing legal and regulatory matters on the sale of medical devices, the marketing and sale of drugs and health care information technology.
Keller Rohrback L.L.P. Files Class Action Lawsuit Against Theranos, Inc. and Walgreens Boot Alliance
Jun 27 16
Keller Rohrback L.L.P. has filed a class action complaint in the United States District Court, Northern District of California against Theranos, Inc. and Walgreens Boot Alliance alleging that Theranos’s “tiny blood test,” that used its proprietary technology “Edison,” did not work. Theranos and Walgreens advertised that the Theranos test could conduct hundreds of blood tests with just a few drops of blood and produce fast results with the high level of accuracy. But the Theranos tests did not work, often required more than a finger prick of blood, and produced inaccurate results, placing tens of thousands of customers at risk for inaccurate medical diagnosis and/or testing. Theranos tests were available from Theranos or through Theranos Wellness Centers located inside Walgreens primarily in Arizona but also in a few locations in California. In May, Theranos conceded that its Edison technology was faulty and voided the results from blood-tests it performed from 2014 and 2015. Theranos issued corrected reports—nullifying some results and revising others—to tens of thousands of patients who may have been given incorrect blood-test results.
Consumers Files National Class-Action Lawsuit Against Theranos Inc
May 26 16
Consumers filed a national class-action lawsuit against Theranos Inc. after investigations and studies indicated that Theranos's proprietary technology was inaccurate, culminating in the company recently voiding tens of thousands of blood tests of customers seen at Theranos facilities in California and Phoenix Walgreens locations, according to consumer-rights law firm Hagens Berman. The complaint filed May 25, 2016, in the U.S. District Court for the Northern District of California, states that Theranos was notified of proposed sanctions and was found to be out of compliance on five Clinical Laboratory Improvement Amendments Condition-level requirements. In a January 25, 2016, letter, CMS outlined all deficiencies and notified Theranos of the seriousness of the deficiencies and found immediate jeopardy to patient safety and health.
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