|Dr. David Helfet, director of the orthopedic trauma service at the Hospital for Special Surgery and New York-Presbyterian Hospital|
Theranos has been taking fire from all sides thanks to regulatory concerns over its proprietary fingerprick blood tests. Now, following independent scientific review of its contentious technology, the Palo Alto, CA-based upstart has boosted the ranks of its scientific advisory board.
The company hosted three scientific review sessions with independent medical and laboratory experts, it said in an April 7 statement.
"Theranos invited groups of independent experts in the fields of Pathology and Laboratory Medicine and literally took the lid off of the box. Experts were shown Theranos' technology, met with Theranos scientists, and had access to any data," said Dr. David Helfet, a co-chair of the board, in the statement. The experts reviewed development and validation reports for small-volume tests using Theranos' technologies, the company said.
Theranos' scientific advisory board now includes "nationally respected laboratory and medical experts," who bring expertise in pathology, epidemiology and diagnostics, disciplines that pertain directly to Theranos' work. The board will work with Theranos in a number of areas, including publishing and presenting in scientific journals and meetings, fully integrating its tests into routine clinical practice, and developing research programs for next-gen testing systems. Board members who are lab directors in their own institutions will work with Theranos to inspect its laboratories and implement best-in-class lab procedures and processes, the company said.
Bolstering its scientific advisory board is just the latest step in controlling the fallout surrounding its diagnostic tests. Once considered to have a rarified valuation exceeding $1 billion, Theranos has been in damage control mode since last October, when multiple reports cast doubt on its testing methods. It stopped marketing all but one of its 200 tests after regulators discovered that the "nanotainers" it used to collect samples were not FDA-approved.
Things got no better when the Centers for Medicare and Medicaid Services (CMS) exposed "deficient practices" that "pose immediate jeopardy to patient health and safety" at Theranos' lab in Newark, CA. The regulator gave the company 10 days to fix the problems, a move that had Walgreens ($WBA) take a long, hard look at its partnership with Theranos. It stopped sending samples to the Newark lab for testing, and is examining its contract with Theranos for a way to exit the union.
Theranos' Scientific and Medical Advisory Board is co-chaired by Elizabeth Holmes and Dr. David Helfet, who previously chaired a Theranos Medical Board Task Force. It now includes Susan Evans, former president of the American Association for Clinical Chemistry's board; Dr. William Foege, former director of the CDC; Larry Kricka, a professor of pathology and laboratory medicine at the University of Pennsylvania; Dr. Andy Miller, an assistant attending physician in infectious diseases at the Hospital of Special Surgery and New York-Presbyterian Hospital; Dr. Steven Spitalnik, a professor of pathology and cell biology at Columbia University; and Ann Gronowski, a professor in the departments of pathology and obstetrics/gynecology, and Jack Ladenson, a professor of clinical chemistry, both at the Washington University School of Medicine in St. Louis.
- here's the statement
Special Report: The most influential people in biopharma today 2016 - Elizabeth Holmes