The Technology Worked
Theranos invested hundreds of millions of dollars in Research and Development. Hundreds of scientists and engineers, including hundreds of PhDs from top universities all over the world, spent 15 years putting blood, sweat, and tears into breakthrough inventions. When the company shut down, it had over 1,000 US worldwide patent assets.¹
Theranos was contracted by pharmaceutical companies to conduct clinical trial testing services. As part of these contracts, Theranos was required to demonstrate that its testing was accurate and reliable through validation reports. Payment was contingent upon successful completion of validation studies showing the tests met accuracy and reliability standards, meaning pharmaceutical companies only paid Theranos if the validation reports demonstrated acceptable performance. Theranos successfully completed these validation studies and received approximately $10 million in total payments from more than 10 pharmaceutical companies, indicating that the testing services Theranos provided met the contracted accuracy and reliability requirements for those specific applications.²
Theranos' core technology was its formula or recipe for running tests on small samples of blood or other fluids. Part of the power of that invention was that the chemistry could run on different devices, much like a great recipe can be cooked using different ovens. Over 300 small sample assays were developed in R&D and their validation reports were presented as evidence at trial by Elizabeth’s defense.3
Over 120 tests and preliminary data were submitted to the FDA for their review, including details of the trade secrets Theranos invented.⁴ After a study on over 600 samples across 3 states with over 60 minilabs, the device, consumable, software, nanotainers, and first small sample test were successfully approved by the FDA.⁵ The minilab also got approval by the FDA to operate as the first CLIA-waived system for HSV testing, miniaturizing the complex laboratory processes run by traditional labs and enabling testing in remote locations by non-medical persons.
Theranos published peer-reviewed studies showing its technologies' performance, including a multi-year study with DoD in which devices were placed in over 12 Burn Centers across the country.⁶
After Quest, LabCorp, and Siemens successfully worked with reporters and regulators to shut Theranos down, they took the technology, moved into the Wellness Centers Theranos built, and are offering fingerstick technology using the very inventions they attacked and Theranos fought to protect.⁷ They of course refuse to offer the $4 lab tests Theranos pioneered and that they fought so aggressively to kill.
Theranos experienced operational failures, but its technology worked. When the company came under attack, it brought dozens of leading experts from academia and medical associations in to examine it. In April 2016, Theranos formed a Scientific and Medical Advisory Board that included past presidents of the American Association for Clinical Chemistry and leading laboratory medicine experts. After reviewing Theranos' data, technologies, and validation reports, Dr. William Foege, former Head of the CDC and recipient of the Medal of Freedom for his work in the eradication of smallpox, wrote publicly: "Initially skeptical, that group of scientists came to realize the tremendous promise of Theranos' technologies." He stated, "In my opinion, the very foundation of Theranos' inventions - and its hundreds of patents - is credible," and "I believe that Theranos can collect, transport and test small samples, including finger-stick, with clinical integrity."⁸
¹ See Holmes Restitution Appeal and Restitution Reply Brief.
² See Holmes Trial Exhibits 7753 and 7742.
³ See Trial Ex 9000 series.
⁴ See Exs request for presubmission meeting with FDA (15028), Pre-submission to FDA (15030, FDA notification of use of 3rd party/conventional devices (7751), 7380.
⁵ See FDA approval
⁶ US Army Burn Center Study, article published about minilab, small sample chemistry, UCSF review of the minilab
⁷ See Quest in Safeway and Walmart, LabCorp in Walgreens, and Babson (Siemens subsidiary) in HEB.