August 28, 2016 1:10 AM ET

Healthcare Providers and Services

Company Overview of Theranos, Inc.

Company Overview

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

United States

Founded in 2003

Phone:

650-838-9292

Fax:

650-838-9165

Key Executives for Theranos, Inc.

Founder, Chairman, Co-Chairman of Scientific & Medical Advisory Board and Chief Executive Officer
Vice President of Regulatory & Quality
Chief Compliance Officer
Compensation as of Fiscal Year 2016.

Theranos, Inc. Key Developments

Theranos, Inc. Unveils Diagnostic-Testing Technologies at American Association for Clinical Chemistry Meeting

Theranos, Inc. presented its research in developing novel technologies for the collection and processing of small-volume venous and capillary blood samples on a compact, fully integrated and automated diagnostic testing platform. The Miniaturization of Laboratory Testing, at the 68th American Association for Clinical Chemistry (AACC) Annual Scientific Meeting & Clinical Lab Expo, also provided precision and method comparison studies for various assays run on the company's miniLab platform. Holmes outlined Theranos' approach to miniaturizing analytical testing equipment across different testing methods, including hematology, immunology, clinical chemistry, immunochemistry, and nucleic acid amplification, and integrating those methods into a single platform, known as the Theranos Sample Processing Unit, or miniLab. The company's testing system is comprised of the miniLab sample-processing unit along with software, called the Theranos Virtual Analyzer (TVA), which will enable remote operation of the unit through a bi-directional connection. Together, this integrated platform is designed to process small capillary whole blood and plasma samples using the company's capillary blood collection devices, the Sample Collection Device (SCD) and Nanotainer(TM) tubes.Theranos also presented topline performance results for the miniLab platform and results on the performance of capillary blood samples on a sampling of assays on the miniLab.Theranos scientists conducted the tests reflected in the AACC presentation in 2016 under IRB-approved protocols, and the company intends to submit the results and conclusions to a publication for peer-review. The technologies covered in the presentation have been not cleared or approved by the FDA and are not for sale in the U.S. The miniLab consists of a multi-channel material-handling robot that can dynamically perform tasks on samples that may traditionally require manual processing. To work with the robot, Theranos devised a disposable cartridge that houses reagents, liquid handling tips, reaction cuvettes, and other consumables designed to facilitate a broad range of tests using different methodologies inside the miniLab. The Theranos Virtual Analyzer (TVA) is designed to facilitate two-way communication with the miniLab, allowing for control of processes and interpretation of results, all remotely. These results could then be interpreted in a central laboratory. The company presented 16 studies on miniLab performance data across a sampling of testing categories and methods, including chemistry, immunochemistry, hematology and molecular biology. These studies were conducted under an IRB-approved protocol. Zika assay run on miniLab: Theranos released results on the nucleic acid detection capabilities of the miniLab, and discussed its Zika nucleic acid-amplification-based assay. The company collected finger- stick samples from subjects, including in the Dominican Republic, and shipped those to Palo Alto to run on the miniLab. The company has submitted assay validation data for this Zika assay to the FDA for an Emergency Use Authorization. The company is unaware of any currently available capillary test for the Zika virus. Capillary collection methods: Holmes described the company's approach to standardizing capillary collection, including sample site preparation, finger-stick techniques, lancet selection and arterialization of capillary blood. To facilitate collection, Theranos invented a single-use sampling device, which is a circuit consisting of two discrete capillary channels coated with anti-coagulants, and integrated, removable Nanotainer(TM) tubes that include 2D barcodes associated with patient information.

Theranos, Inc. Announces Executive Appointments

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

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.

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