PALO ALTO — Facing questions and criticism about its blood measuring technology, Theranos has added several nationally respected laboratory and medical experts to the company’s Scientific and Medical Advisory Board, whose membership now includes: Susan A. Evans, PhD, FACB, former president of the American Association For Clinical Chemistry (AACC); Bill Foege, MD, former Director of the U.S. Center for Disease Control and Prevention (CDC); Ann M. Gronowski, PhD, DABCC, Department of Pathology and Immunology and the Department of Obstetrics and Gynecology at the Washington University School of Medicine in St. Louis; David Helfet, MD, Hospital for Special Surgery and New York-Presbyterian Hospital, Weill Cornell Medicine; Larry J. Kricka, D. Phil, FRCPath, University of Pennsylvania; Jack Ladenson, PhD, DABCC, Washington University School of Medicine; Andy O. Miller, MD, Hospital for Special Surgery and New York-Presbyterian Hospital, Weill Cornell Medicine; and Steven Spitalnik, MD, Columbia University Medical Center (CUMC).
The board was expanded after the company hosted three scientific review sessions with leading laboratory and medical experts who were invited to review the company’s proprietary technologies. Theranos provided the experts full exposure to its systems, devices, and data. The independent experts reviewed development and validation reports for tests performed on small volume samples, including finger-sticks, using Theranos’ proprietary technologies for a variety of assays, including assays of their choice.
“It is clear that Theranos has done what people thought was impossible,” said David Helfet, MD, director of the Orthopedic Trauma Service, Hospital for Special Surgery and New York-Presbyterian Hospital, and a co-chair of the board. “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. Theranos’ technology is a groundbreaking feat of science and engineering, making it possible to accurately analyze micro amounts of blood for the same tests routinely done today with traditional venipuncture,” Helfet continued.
“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 board will work alongside Theranos’ leadership and internal teams 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. In addition the board will 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.
The members who are laboratory directors in their own institutions will work with the company to help inspect its clinical laboratories, and help the clinical laboratory directors with the implementation of best in class lab procedures and processes.
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. Full bios of the board members follow:
- Susan A. Evans, PhD, FACB
Dr. Evans has over 30 years of experience in diagnostics and health technology companies. She served as President, Secretary, and member of the Board of Directors for the American Association for Clinical Chemistry (AACC), for which she received an award in 2008 for outstanding contributions through service to the profession. Dr. Evans also served as a member of the Board of Directors and President of the National Academy of Clinical Biochemistry (NACB), now the Academy of the AACC.
- William H. Foege, MD
Dr. Foege is an epidemiologist and former Director of the U.S. Center for Disease Control and Prevention (CDC). He is recognized as the health innovator behind the successful campaign to eradicate smallpox in the 1970s, Dr. Foege received the Presidential Medal of Freedom in 2012, the nation’s highest civilian honor. He was a senior medical advisor for the Bill and Melinda Gates Foundation from 1999 until his retirement in 2011. Dr. Foege is a member of the Theranos Board of Counselors and has served on Theranos’ Medical Board.
- Ann M. Gronowski, PhD, DABCC
Dr. Gronowski is 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. She is board certified in Clinical Chemistry and is Co-Medical Director of the clinical chemistry, serology, and immunology laboratories at Barnes-Jewish Hospital. She is a past President of the American Association of Clinical Chemistry (AACC) and a past President of the American Board of Clinical Chemistry (ABCC). Dr. Gronowski is author of over seventy peer-reviewed articles and a number of textbooks including Tietz’s Applied Laboratory Medicine and Handbook of Clinical Laboratory Testing During Pregnancy.
- David Helfet, MD, Co-Chairman
Dr. Helfet is the Director of the Orthopedic Trauma Service, Hospital for Special Surgery and New York-Presbyterian Hospital, and Professor of Orthopedic Surgery, Weill Cornell Medicine. Dr. Helfet is the Past President of the Orthopaedic Trauma Association and has been extensively involved nationally and internationally on boards and courses dealing with trauma. Dr. Helfet is annually ranked as one of New York Magazine’s “Best Doctors in New York” and Castle-Connolly’s “America’s Top Doctors.” Dr. Helfet has published extensively on orthopedic trauma topics including numerous articles and book chapters.
- Larry J. Kricka, D. Phil, FRCPath
Dr. Kricka is a professor of Pathology and Laboratory Medicine at the University of Pennsylvania and was director of the General Chemistry Laboratory and the Endocrinology Laboratory at the Hospital of the University of Pennsylvania. He is a Fellow of the Royal College of Pathologists, and a member of the Editorial Board of Clinical Chemistry, and Analytical Biochemistry, and past editor-in-chief of Luminescence. He was President of the American Association for Clinical Chemistry (AACC) in 2001 and was a member of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Executive Board. Dr. Kricka holds over 30 U.S. patents; and is the author/co-author of over 500 articles, abstracts, book chapters, and papers; and 22 books.
- Jack Ladenson, PhD, DABCC
Dr. Ladenson is the Oree M. Carroll and Lillian B. Ladenson Professor of Clinical Chemistry at Washington University School of Medicine. He has been active in a number of professional organizations and has served as President of the American Association for Clinical Chemistry (AACC) and the Academy of Clinical Laboratory Physicians and Scientists (ACLPS). He is also a past chair of the Editorial Board of the journal Clinical Chemistry. He has received numerous awards from professional organizations, Washington University, and its Medical Alumni Association. He also directs clinical pathology programs for Pathologists Overseas Inc.
- Andy O. Miller, MD
Dr. Miller is an Assistant Attending Physician in Infectious Diseases at the Hospital for Special Surgery and New York-Presbyterian Hospital, and an Assistant Professor of Clinical Medicine at Weill Cornell Medicine. His areas of clinical expertise and research activity are orthopedic and rheumatologic infectious disease. He has been selected for inclusion on the Super Doctors® 2015 list. He is board certified in Infectious Diseases and Internal Medicine by the American Board of Internal Medicine.
- Steven Spitalnik, MD
Dr. Spitalnik is a Professor of Pathology and Cell Biology and the Vice-Chairman of Laboratory Medicine at Columbia University Medical Center (CUMC). As the Medical Director of the Clinical laboratories on the CUMC campus of the New York-Presbyterian Hospital, he coordinates the clinical service, educational, and scholarly activities of the Division. In addition, he is the Co-Director of the Laboratory of Transfusion Biology, which pursues NIH-funded research aimed at improving transfusion practice. He is a long-standing member of the Academy of Clinical Laboratory Physicians & Scientists, serving as its President in 2002-03 and, in 2005, receiving its Gerald T. Evans Award for outstanding leadership and service to the Academy. In addition to being board certified in both Anatomic and Clinical Pathology, Dr. Spitalnik is a member of the Editorial Boards of Transfusion, Transfusion Medicine Reviews, and Current Opinion in Hematology, and is the lead author of Clinical Pathology Board Review.
Theranos’ Scientific and Medical Advisory Board will meet quarterly.