This op-ed originally appeared in TheHill.com on July 19, 2016.
Theranos was founded with the goal of providing low-cost, high-integrity health information. The company has since developed unique lab and testing technologies using small samples of blood, urine, and other specimens – some taken with a simple prick of the finger instead of a large syringe. As a member of Theranos’ Scientific and Medical Advisory Board (SMAB), I have been asked repeatedly about the company and its science. Those questions have only grown more frequent after federal regulators’ recent scrutiny of the company. There is another side to the story.
I was initially drawn to Theranos because of the implications for global public health. Theranos’ vision can have a profound impact on public health through increasing access to clinical testing and reducing costs, while enabling the testing of individuals, animals and the environment (soil, water) in areas without ready access to labs. The SMAB was formed to help Theranos communicate to the world the science and technologies it has developed to realize this vision. While I don’t purport to speak for the full SMAB, I can report on why I joined and why I continue to believe in and support the company.
Earlier this year, the company invited a group of scientists to Theranos’ California headquarters and lab. We were given access to Theranos’ data and technologies, including the internal architecture of its testing devices and instruments. We were allowed to review any assay development and validation reports of our choosing for tests Theranos performed on small-volume samples.
We met with Theranos scientists who demonstrated the company’s ability to accurately process small samples on a range of tests. Finally, we experienced the finger-stick collection process ourselves, receiving reliable results. Initially skeptical, that group of scientists came to realize the tremendous promise of Theranos’ technologies. And that is the group that later signed on to form what is now the SMAB.
In my opinion, the very foundation of Theranos’ inventions – and its hundreds of patents – is credible. The company’s intellectual property is clearly robust, and many potential partners still request meetings to learn more about the technologies. Under the leadership of Elizabeth Holmes, the company will continue to grow and develop the business. Small sample testing is as inevitable as the shrinking of computers from room-size machines to the tiny footprint of a smart phone.
Based on my experience, I believe that Theranos can collect, transport and test small samples, including finger-stick, with clinical integrity. This ability has break-through potential by expanding access to testing close to home or in remote locations. The applicability for mosquito-borne diseases is profound, in particular for pregnant women who are at risk for transmitting disease to their unborn or newborn baby. Theranos’ tests are pending before FDA and, if authorized, would provide rapid access to critical information.
I am committed to being a part of the company’s path forward and helping to rebuild the public’s trust in the face of a great deal of confusion and misinformation. To that end, the SMAB is heeding the call by the medical and academic communities by helping the team prepare manuscripts for the publication of its data in peer-reviewed scientific journals and presentations at public meetings. Theranos has a strong and exciting future ahead. I look forward to being a part of it.
William H. Foege, MD, MPH, is a member of Theranos’ Scientific and Medical Advisory Board and the Board of Directors. An epidemiologist, Dr. Foege is the former director of the U.S. Centers for Disease Control and Prevention, and former senior medical adviser for the Bill and Melinda Gates Foundation. He received the Presidential Medal of Freedom in 2012 for his leadership in the eradication of smallpox in the 1970s.