CEO SUMMARY: Theranos Founder and CEO Elizabeth Holmes will be in Philadelphia to present to the American Association of Clinical Chemistry (AACC) data about the technology developed at Theranos. Conference organizers said Holmes would answer ques- tions to clarify the science, accuracy, and reliability of the lab company’s technologies and its effect on patient care and safety. AACC members have the knowledge and experience in clinical lab science to assess Theranos’ results and claims.
IS ELIZABETH HOLMES, THE FOUNDER and CEO of Theranos, Inc., finally going to describe how her company’s devices work for finger-stick blood collection and small-sample-size testing? Will she also present data showing the clinical utility of the processes Theranos uses?
Clinical laboratory professionals may learn the answers to these questions on August 1 when Holmes is scheduled to address a special session at the Annual Scientific Meeting & Clinical Lab Expo of the American Association of Clinical Chemistry in Philadelphia.
In April, AACC announced that Holmes would address AACC members during a 90-minute session at the Pennsylvania Convention Center. At least half of the time will be devoted to questions from association members, stated AACC President Patricia M. Jones, PhD.
“She’s promised us the science; she’s promised us the data. We’re just providing a forum,” explained Jones, who is the Clinical Director of Chemistry at the Children’s Medical Center in Dallas. “In recent years, the AACC members, myself included, have regularly asked, ‘Where’s the science?’
“Now we have the opportunity to see the science during this session,” she con- tinued. “And, not only will we hear her presentation, but there will also be a real- time question-and-answer period for our members to ask unvetted questions of Elizabeth Holmes. We’re looking forward to this opportunity.”
Patient Safety Questions
When it announced the event, AACC said Holmes would answer questions to clarify the science, accuracy, and reliability of Theranos’ technologies and its effect on patient care and safety. Unlike many other groups Holmes has addressed in recent years, AACC members have the knowledge and experience in clinical laboratory science to assess the science and data Holmes will present.
“We invited her to bring other science people with her if she wants to do that,” commented Jones. “We said, ‘Bring whoever you need to bring to explain the science and the data.’ ”
“What’s most exciting about this session is that we are experts in this field. Science and technology is what we do,” emphasized Jones. “So, in that way, we can ask the best questions to make sense of the technology Theranos uses. That is one reason we hope that good things will come out of this meeting.
“It’s important for every lab, including Theranos, to put the science and data out there so that other scientists know what is being done,” she said. “That’s what makes this meeting a prime opportunity to begin vetting their science and their data.
Scientists Prefer Openness
“Scientists prefer to be open about what they are doing,” noted Jones. “We want to share what we’re learning and developing with our colleagues. Doing so helps us to move diagnostic technology forward because when we are open about what we do, our discoveries and our technology get vetted by lots of people.”
Since 2014, AACC has asked Holmes to address its annual scientific meeting and Holmes has declined in each of the previous two years, Jones said. “But this year she agreed, and we’re excited to hear from her,” she said. “Just because we invited her does not mean we are endorsing her in any way. All we’ve done is provide a forum for her to present the science behind the testing Theranos does.”
In answer to a question, Molly Polen, AACC’s Director, Communications and Public Relations, responded that Theranos did not and has never provided sponsorship funds or other forms of grants to the association.
The AACC meeting will not address the regulatory questions dogging Theranos, Jones said. Instead, the focus will be on the science and technology Holmes and her team at Theranos have developed. “It’s true that the whole laboratory industry around the world is watching Holmes,” she said. “But we’re going to keep our focus completely away from anything that has to do with regulatory activity. We want to see the science.”
AACC will allow members and possibly other members of the audience to ask questions in real time. Questions will not come from members of the audience using microphones, Jones explained.
Theranos Adds Scientists to its Advisory Board
IN APRIL, THERANOS ANNOUNCED that new laboratory and medical experts had joined its Scientific and Medical Advisory Board, including these four former AACC presidents:
- Susan A. Evans, PhD, FACB; Vice President and General Manager of Agencourt Bioscience, a division of Beckman Coulter Corporation;
- Ann M. Gronowski, PhD, DABCC, of the Department of Pathology and Immunology and the Department of Obstetrics and Gynecology at the Washington University School of Medicine in St. Louis;
- Larry J. Kricka, DPhil, FRCPath, of the University of Pennsylvania; and
- Jack Ladenson, PhD, DABCC, of the Washington University School of Medicine;
Others joining the advisory board were
- Bill Foege, MD, former Director of the U.S. Centers for Disease Control and Prevention;
- David Helfet, MD, Hospital for Special Surgery and New York-Presbyterian Hospital, Weill Cornell 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.