- Theranos on Thursday announced the addition of a number of medical and laboratory experts to its medical advisory board, bulking up on scientific expertise as it faces serious questions on the accuracy of its proprietary finger-prick blood testing technology.
- The company has been criticized in the past for filling out its board of directors with political and security heavyweights, such as former Secretary of State Henry Kissinger and former Senator Sam Nunn, rather than scientists. Theranos later shrunk the board from 12 members to 5 members, and formed a separate board of counselors, which now includes Kissinger and Nunn.
- New members to the medical board were able to review Theranos' systems, devices, and data, and will advise the company on transitioning its technology into "routine clinical practice".
Adding experienced scientists and researchers to the medical board should help Theranos address concerns over the number of advisors with relevant experience to its blood-testing business.
“We are honored and humbled to bring together, and have the support of, such a distinguished and respected group of laboratory and medical leaders,” said Elizabeth Holmes, founder and CEO of Theranos. “We could not be more proud to have the opportunity to work together with these incredible individuals as we work to build best in class systems across our labs and product development initiatives.”
The new members of the board include (among others) William Foege, a former director of the U.S. Center for Disease Control and Prevention, Steven Spitalnik, the vice-chairman of laboratory medicine at Columbia University Medical Center, and Susan Evens, former President of the American Association for Clinical Chemistry.
But the company still faces serious problems. A recently released report from the Centers for Medicare and Medicaid Services gave new details of deficiencies found during a fall 2015 inspection of Theranos' Newark,CA lab. That inspection had led to a CMS letter warning the violations posed “immediate jeopardy to patient health and safety.”
The report revealed that 29% of the quality-control checks on Theranos' proprietary testing device provided results which were out of range with the company's own standards. The company has taken steps to remedy these deficiencies, but the report only adds to existing questions on the accuracy of Theranos' tests.
The medical board will meet quarterly and advise the company on integrating its technology into clinical use, along with advising Theranos on publication in scientific journals.