June 17, 2016
By Alex Keown, BioSpace.com Breaking News Staff
Palo Alto, Calif. – Detractors of embattled blood-testing company Theranos calling on the company to share scientific data on its proprietary technology will soon get their wish. Founder Elizabeth Holmes is scheduled to present data at the American Association for Clinical Chemistry‘s annual conference on Aug. 1.
This will be the first time that Theranos has publicly shared its own scientific data, Business Insider reported this morning. The AACC released Theranos’ abstract information which shows the company will be an education presentation and is not attached to any specific study data, Business Insider noted. Additionally, Holmes will present information on how the finger-prick tests work and how it stands up in comparison to standard blood-draw tests. Business Insider noted that among the tests Holmes and Theranos will demonstrate is one to determine the Zika virus.
“This presentation will describe the Theranos lab testing framework, which consists of a finger-stick blood collection and storage device, technologies for processing small volume samples in a centralized setting, and a compact fully-integrated and automated field-deployable diagnostic testing platform. Ms. Holmes will present reproducibility and correlation data for various tests comparing Theranos’ capillary collection and storage device with traditional venipuncture methods,” Theranos’ abstract says, as Business Insider reported.
Following her presentation, Holmes will participate in a moderator-led question and answer session. With Theranos under federal as well as industrial scrutiny, the Q&A session could get lively as Holmes is grilled about the efficacy of her company’s technology, lawsuits facing the company over the invalidation of two-years’ worth of blood tests and the recent decision by Walgreens to terminate its relationship with the company.
For the past nine months, Holmes and Theranos have been under intense scrutiny over the efficacy of the blood testing product, particularly after the company voided two years’ worth of data sent to customers. Although Theranos said that data only amounted to about 1 percent of blood tests, there were reportedly tens of thousands of corrected results sent to patients and doctors. So far there have been a few lawsuits filed against the company from customers who relied on the tests for health treatments. Brooke Buchanan, vice president of communications at Theranos, told BioSpace last month that the lawsuits were without merit and the company “will vigorously defend itself against these claims.”
In addition to dissatisfied patients, the company is also facing other legal problems. In April, the U.S. Department of Justice launched a criminal investigation into the company, with investigations centering on whether or not Theranos and its executives misled investors as to the efficacy of its blood-testing products. News of a criminal investigation comes less than a week after reports revealed that Holmes could face a possible federally-mandated two-year suspension from the blood testing industry over failures to address deficiencies at lab facilities in California raised by the U.S. Center for Medicare and Medicaid Services. In a lightly redacted 45-page letter dated March 18 over those concerns, the CMMS repeatedly used the bold-texted phrase “The laboratory’s allegation of compliance is not credible and the evidence of correction is not acceptable.” The phrase is used to indicate how Theranos’ addressing of issues that fail to meet federal Clinical Laboratory Improvement Amendments (CLIA) guidelines.
Although Theranos has been criticized for not sharing scientific data, the company recently began to undertake a structural reorganization of its leadership and added three new members to its board of directors with a wealth of scientific experience. Theranos added Fabrizio Bonanni, a former senior executive at Amgen in charge of quality and compliance; William Foege, an epidemiologist and former director of the U.S. Centers for Disease Control and Prevention; and Richard Kovacevich, a former chief executive officer of Wells Fargo & Co.
