|Headquarters||Palo Alto, California, United States|
|Elizabeth Holmes, Chairman, CEO and Founder, Ramesh "Sunny" Balwani, President and COO, George P. Shultz, Board Member, William J. Perry, Board Member, Samuel Nunn, Board Member, Henry A. Kissinger, Board Member, Richard Kovacevich, Board Member, Gary Roughead, Board Member, James N. Mattis, Board Member|
Theranos is an American privately held health-technology and medical-laboratory-services company based in Palo Alto, California that has developed novel approaches for laboratory diagnostic tests using blood. The company's blood-testing platform uses a few drops of blood obtained via a finger-stick rather than vials of blood obtained via traditional venipuncture, and utilizes microfluidics technology.
She had previously founded a software company and worked on a protein microarray for the detection of SARS in Singapore, and left Stanford University at age 19 while a sophomore majoring in chemical engineering, to start Theranos with a bridge loan from a venture capitalist. Holmes' Stanford chemical engineering professor Channing Robertson had encouraged her in the endeavor, and joined the board of directors. The company had raised $16 million in two rounds of initial fundraising, and $28.5 million in a third round in 2006.
In 2010, Theranos raised an additional $45 million from a single unnamed investor, bringing its total funding to more than $70 million. Investors include Draper Fisher Jurvetson, ATA Ventures, Tako Ventures, Continental Properties Inc., and Larry Ellison, former CEO of Oracle.
In July 2015, the Food and Drug Administration approved Theranos' platform — its hardware, software and blood-drawing equipment — as well as its herpes simplex virus (HSV-1) blood test, which tests for disease using a finger-prick's worth of blood. Days later, Theranos received a FDA clearance, also known as a CLIA waiver, to administer its herpes blood test outside a traditional clinical laboratory. This allows the blood test to be administered by non-laboratory personnel and trained workers. Although this FDA waiver applies only to this one test, Theranos announced it is pursuing FDA clearances on more than 120 other diagnostic exams it performs using similar hardware and software.
Theranos hosted U. S. vice president Joseph Biden at its Newark, Calif. production facility in July 2015. Biden complimented the company for cutting costs in the bloodwork process, manufacturing in the U.S. and being at the "forefront of a paradigm shift in health care."
Starting in 2007, the company has three times unsuccessfully sued former allies: First, it filed suit in Santa Clara, California, accusing former employees of breaching company secrecy. It also filed suit, claiming intellectual property theft, against a former partner of the law firm McDermott Will & Emery,[vague] a case that was dismissed in June 2012. Another case, in Washington, D.C. and against the law firm itself, was dismissed in August 2013.
In 2006, Holmes was named one of Inc. magazine's "30 under 30" for her work with Theranos. In 2012, the Palo Alto-based company moved its headquarters into a building previously occupied by Facebook, to accommodate rapid growth, and opened a second site for manufacturing operations in Newark, California, in 220,000 sq ft offices owned by BioMed Realty Trust. The company was noted as an example of disruptive technology in 2013 by Bill Frist, and as one of the 10 Top Medical and Technological Innovations of 2013 by Healthline.
As of 2013[update] the company had been secretive about its plans and operations in order to maintain confidentiality - “operating deeply in ‘stealth mode’” - and had rarely issued public statements or granted interviews to the media. An exclusive interview with Holmes in the Wall Street Journal in September 2013 marked a shift to going more public.
In February 2015, a Journal of the AMA editorial noted[vague] that information about such technology had appeared in the mainstream press including The Wall Street Journal, Business Insider, San Francisco Business Times, Fortune, Forbes, Medscape, and Silicon Valley Business Journal, but not in the peer-reviewed biomedical literature.
While other aspects of its operations remain secretive, Theranos corporate governance has been the subject of various press disclosures and subsequent news reports.
In July 2013, the composition of the Theranos board of directors changed markedly, with departure of Channing Robertson (emeritus professor, chemical engineering, Stanford University), experienced pharma and biotech executive Robert B. Shapiro (former chairman/CEO of the Pharmacia, Monsanto, and G.D. Searle group of companies), and financier Pete Thomas (principal, ATA Ventures). Remaining from the original board were Theranos President and COO Ramesh "Sunny" Balwani and former Secretary of State George Shultz; added to the new board were Riley P. Bechtel (chairman of the board at Bechtel Group), Richard Kovacevich (former Wells Fargo Chairman and CEO), Sam Nunn and Bill Frist (former U.S. Senators), Henry Kissinger (former Secretary of State), William Perry (former Secretary of Defense), William Foege (epidemiologist, former director U.S. CDC), James Mattis (General, USMC, retired) and Gary Roughead (Admiral, USN, retired), several of whom are members of Stanford's Hoover Institution, with medical doctors Frist and Foege, and lawyer/executive Bechtel being added most lately (in 2014).
A consequence of these 2013 changes, noted Ron Leuty of the San Francisco Business Times, was that "Theranos’ board… consists mainly of directors with diplomatic or military backgrounds." While two physicians have subsequently been named to the board, and published reference has been made to a "deep medical advisory group," as of January 2015, no scientific or medical advisory board information appears in the company's public information.
Theranos 1.0 Device
|This section requires expansion. (January 2015)|
As described in general terms for a business periodical in 2006, Theranos' device design uses a fingerstick to draw a microliter sample of blood into a disposable cartridge, which is loaded into the device's "reader" for analysis; results are sent wirelessly from the reader to a secure database, from where they go online to the patient or patient's physician. The company's device claims include that the results will be received faster than the usual three-day delay for centralized laboratory testing, that up to 30 blood tests can be performed on a single sample, and that its design will ensure accuracy by reducing or eliminating human handling and delays associated with traditional tests.
The company reports that tests are being performed at a CLIA-certified laboratory; as of January 2015 the documentation on each test includes analyte being detected, and the approved means of detection.
Services and service cost claims
Theranos disclosed to Inc. magazine that it initially targeted its blood testing services at new-to-market drugs involved in clinical trials, because frequent testing is required to indicate whether a new drug therapy is efficaceous or causing adverse reactions. Since this disclosure, Theranos has begun to offer services directly to consumers via Theranos Wellness Centers located inside Walgreens stores (beginning in 2013), with, as of January 2015, one posted location in Palo Alto, CA, and forty posted locations in Phoenix, AZ. While reports have appeared that Theranos' blood tests mainly cost under $10, as of January 2014, prices had been posted for more than 235 available tests at Walgreens, Inc. (online, via outlink to the Theranos site), ranging in price from $1.55 to $117.96 (for an "Auto" urinalysis and a genotypic test for Hepatitis C virus, respectively), with many in the range of $2 to $20, and typical panel prices being on the order of tens of dollars (e.g., with the combined tests of a standard Comprehensive metabolic panel of protein, electrolytes, sugar, cholesterol, and kidney and liver enzyme tests accruing at Walgreens-Theranos to ~$45.) (As noted, full information on each test is not available at the Walgreens or Theranos sites, as of January 2015.) Based on its calculations regarding its pricing and test use by American consumers, the company has made claims that low-cost blood tests could save U.S. Medicare and Medicaid, on average, around $20 billion per annum.
As of July 2015[update], Theranos held more than 26 issued patents, including patents on wearable blood monitors and influenza virus detection. The medical device for analyte monitoring (medicine) and drug delivery is "ingestible, implantable or wearable [...] comprising a microarray which comprises a bioactive agent capable of interacting with a disease marker biological analyte; a reservoir which comprises at least one therapeutic agent and is capable of releasing the therapeutic agent(s) from the medical device; and a plurality of microchips comprising a microarray scanning device capable of obtaining physical parameter data of an interaction between the disease marker biological analyte with the bioactive agent." A 2014 patent is for information management systems and methods using a biological signature, which may be used to verify the identity of the individual who may be granted access to a secured location, item, and/or service or to search or aggregate records for an individual.
Among Theranos' software-based inventions are "Systems and methods for response calibration", a patent for calibrating user responses to questions, as for example in health surveys. Another patent is for assisted medical and associated lifestyle decision making or methods and systems for assessing clinical outcomes using "computer-assessed methods, medical information systems, and computer-readable instructions that can aid an end-user in diagnosis, prognosis, and treatment".
- Leuty, Ron (30 August 2013). "Theranos: The biggest biotech you’ve never heard of". San Francisco Business Times. Retrieved 9 March 2014.
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- Parloff, Roger (16 July 2015). "A second FDA approval frees Theranos to do a blood test outside lab". Fortune Magazine. Retrieved 16 July 2015.
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- Weisul, Kimberly. "Why Vice President Joe Biden Is So Inspired by Elizabeth Holmes". Inc. Inc. Magazine. Retrieved 24 July 2015.
- Parr, Rebecca. "Vice President Joe Biden visits biotech firm Theranos's Newark production facility". mercurynews.com. San Jose Mercury News. Retrieved 24 July 2015.
- Overly, Jeff (5 August 2013). "McDermott Ducks Health IT Client's IP Theft Suit". Law360 (LexisNexis). Retrieved 9 March 2014.
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- John P. A. Ioannidis (February 17, 2015). "Stealth Research: Is Biomedical Innovation Happening Outside the Peer-Reviewed Literature?". JAMA 313 (7): 663–664. doi:10.1001/jama.2014.17662.
- Ron Leuty, 2013, "Theranos: The biggest biotech you’ve never heard of" San Francisco Business Times (online), Aug 30, 2013, accessed 28 January 2014. Quote: "Theranos continues to move stealthily. Requests to speak with Holmes or other executives, board members and the company’s financiers were consistently rebuffed, and the company declined to provide any answers to written questions."
- Stanford Engineering, 2014, "Channing Robertson Timeline," see , accessed 28 January 2014
- Leuty, Ron (2 August 2013). "Theranos adds Kovacevich to all-star board". San Francisco Business Times. Retrieved 9 March 2014.
- Leuty, Ron (29 July 2013). "Quiet Theranos adds former Wells chief Kovacevich, 'Mad Dog' Mattis to power-packed board". San Francisco Business Times. Retrieved 9 March 2014.
- Anon., 2015, "Company Overview of Theranos, Inc.: …Key Developments," in BloombergBusiness (online), see , accessed 28 January 2014
- Anon., 2014, "Theranos Appoints Riley P. Bechtel to its Board of Directors," BusinessWire (online), March 25, 2014, see , accessed 28 January 2015.
- Marco della Cava, 2014, "Change Agents: Elizabeth Holmes wants your blood, USA Today (online), July 26, 2014, see , accessed 28 January 2014
- Roper, Caitlin (2014-02-18). "This Woman Invented a Way to Run 30 Lab Tests on Only One Drop of Blood". Wired. Retrieved 2014-03-06.
- Chokshi, Dave (2014-02-03). "A 3-Fold Plan for a New Preventive Medicine". Scientific American (guest blog).
- "WAG to offer Theranos lab services". Zacks Equity Research. 2013-09-10. Retrieved 2013-09-16.
- See for instance, , accessed 28 January 2015.
- MedlinePlus, 2015, "Comprehensive metabolic panel", see , accessed 28 January 2015
- Walgreens, Inc.., 2015, "Theranos Lab Testing: Test menu," at Walgreens:Pharmacy & Health, see , accessed 28 January 2015
- For further instances, as of January 2015: posted prices for a DNA-based Chlamydia-Gonorrhea panel was $29.95, for a multi-class drug screen was $49.95, for a sexually transmitted infection panel was $59.95, a test for extractable nuclear antigen antibodies at $73.95, etc. See immediately preceding reference, Walgreens (2015).
- See, for instance, the "Drug Screen, Multi Class" page, in the preceding reference for the Theranos outlink at Walgreens,  accessed 28 January 2015.
- Parloff, Roger (2 July 2015). "Disruptive diagnostics firm Theranos gets boost from FDA". Retrieved 16 July 2015.
- "Patents held by Theranos". Retrieved 30 September 2014.
- Segall, Eli (29 June 2012). "Theranos founder dropped out of Stanford to start company". Silicon Valley Business Journal. Retrieved 9 March 2014.
- Theranos, Inc. (January 24, 2012). "Medical device for analyte monitoring and drug delivery". US Patent Office. Retrieved 24 February 2015.
- Theranos, Inc. (January 24, 2012). "Information management systems and methods using a biological signature". World Intellectual Property. Retrieved 24 February 2015.
- Theranos (April 3, 2014). "SYSTEMS AND METHODS FOR RESPONSE CALIBRATION". United States Patent and Trademark office. Retrieved 24 February 2015.
- Theranos (April 3, 2014). "Assisted medical and associated lifestyle decision making". World Intellectual Property. Retrieved 24 February 2015.
- Theranos (Sep 11, 2012). "Methods and systems for assessing clinical outcomes". US Patent Office. Retrieved 24 February 2015.
- Official website
- Topol, Eric J. (18 November 2013). "Creative Disruption? She's 29 and Set to Reboot Lab Medicine". Medscape. Retrieved 9 March 2014.
- Holmes, Elizabeth (4 March 2009). "Audio Podcast: Developing the Future of Home Healthcare". ecorner. Stanford Technology Ventures Program. Retrieved 9 March 2014.
- "Theranos: The Breakthrough of Instant Diagnosis". WIRED Data | Life. fora.tv. Retrieved 9 March 2014. (video)
- "Theranos Becomes a Successful Startup Ventures". Retrieved 1 March 2015.