April 8, 2016
By Alex Keown, BioSpace.com Breaking News Staff


PALO ALTO, Calif. – Embattled blood-testing company Theranos is making some moves to counter criticism lobbed at the company’s leadership and the efficacy of its testing by adding more medical experts to its advisory board and opening proprietary data to scientific reviewers.

Theranos has been under fire since last fall over concerns its blood-testing technology was not as accurate as billed and also for a lack of scientific leadership on a board of directors that included a number of Washington, D.C. influencers. But that was something the company changed this week. In an emailed statement, Brooke Buchanan, Theranos’ vice president of communications, told BioSpace (DHX) the company tapped several new medical advisers, including Susan Evans, former president of the National Academy of Clinical Biochemistry, epidemiologist William Foege, who formerly served as director of the U.S. Centers for Disease Control and Prevention, and Ann Gronowski, a professor in the Department of Pathology and Immunology and the Department of Obstetrics and Gynecology at the Washington University School of Medicine in St. Louis. Other members tapped for the board include David Helfet, a New York-Presbyterian Hospital physician; Larry J. Kricka, of the University of Pennsylvania; Jack Ladenson, of the Washington University School of Medicine; Andy O. Miller, a doctor at New York-Presbyterian Hospital; and Steven Spitalnik, a doctor at Columbia University Medical Center.

The backing of medical professionals will likely help Theranos navigate through the scathing criticism it has received since late 2015. Theranos said the new board members will work alongside company leadership in various areas, including “advising Theranos regarding the full integration of its technology into routine clinical practice, and publication and presentation in scientific journals and at scientific meetings.” Theranos also said the advisory board will also “provide guidance on associated intellectual property initiatives, and will work with Theranos’ scientists and engineers on research programs associated with its next generation test systems.”

In an interview with Business Insider, Helfet said he has been talking with Theranos leadership for about three years on what a medical advisory board should look like. One of the recommendations he made was to have the company’s proprietary blood-testing technology independently tested and reviewed, something the company had finally taken to heart with three scientific review sessions with laboratory and medical experts who reviewed the company’s technologies with “full exposure to its systems, devices and data.” Helfet said the next step will be for the company to “present the data to the scientific community,” something the company has been heavily criticized for not doing.

“This group together is really going to help not just Theranos, but all of the scientists out there who are involved, to understand the technology and utilize the technology and science,” Helfet told Business Insider.

Earlier this month Theranos, which has an estimated value of $9 billion, took another hit to its reputation after A scathing government report shows Theranos’ Edison blood testing devices has failed to meet the company’s own standards. The U.S. Centers for Medicare and Medicaid Services (CMMS) released a 121-page report of its findings following a series of inspections at Theranos’ Newark, Calif. lab and the news for the company valued at $9 billion based on its proprietary blood-testing is not good. The CMMS report showed 29 percent of quality control checks performed on Theranos’ Edison devices in October 2014 “produced results outside the range considered acceptable by Theranos,” the Journal reported. A February 2015 test using the Edison device to measure testosterone levels failed quality control checks 87 percent of the time. The CMMS report shows several months-long stretches of quality control issues when it comes to the Edison device.

In a statement on the Theranos’ website, Brooke Buchanan, Theranos’ vice president of communications, said the company has dedicated every resource to make corrections to the Newark lab. She noted several course corrections the company has made to the lab, including personnel changes, the adoption of “enhanced “quality systems, policies and procedures” and the suspension of some testing at the Newark site. Buchanan said the company has also “voided results associated with any findings that were not consistent with the quality standards the lab holds itself to today, under our lab’s new leadership.”


Source: BioSpace