This secretive start-up medical laboratory testing company has not disclosed how its diagnostic test technology works, nor has it given laboratorians an opportunity to examine the technology

Several internationally-respected clinical laboratory experts are asking serious questions about Theranos and its diagnostic testing technology, and they’ve gotten few answers to date. Though the number of experts is small, their credentials in the clinical laboratory profession are impressive. In addition, some have published their critiques of the start-up medical laboratory company in well-respected medical journals.

One question these clinical pathologists and laboratory directors ask is why Theranos has so far been unwilling to provide more information about the lab testing technology it uses to deliver medical laboratory test results to patients and their referring physicians. Even as the company has declined to speak to the medical laboratory profession, Theranos has mounted a major public relations campaign designed to make a big impression on investors, business partners, and most recently on health insurers.

The clinical laboratory company in Palo Alto, Calif., gets plenty of attention because it claims to have disruptive technology that will allow it to perform medical laboratory tests equivalent to the current standard of care. Theranos says it can do this using a capillary specimen and return results in four hours, while charging a price that is just 50% of Medicare Part B lab test fees. Given these assertions, it is natural that pathologists and laboratory scientists who perform tests for patients, are curious about the scientific basis of Theranos’ proprietary diagnostic technology and what evidence Theranos has developed to support its claims of comparable accuracy and reproducibility.

Theranos Enjoys a Steady Stream of Uncritical News Coverage

In September 2013, Theranos attracted national headlines following a positive company profile published in The Wall Street Journal. Shortly thereafter, Theranos announced an agreement with Walgreens Inc., to place its Theranos Wellness Centers in the 8,300 Walgreens Pharmacies across the United States. This news caught the attention of pathologists and clinical laboratory professionals here and abroad.

Since that time, Theranos has enjoyed a steady stream of press coverage, nearly all of it positive. Some pathologists and clinical chemists have observed, however, that they know of no published statements come from an individual trained in pathology and laboratory medicine and working with the company.

Promises, Fallacies and Exaggerated Claims

Thus, it was only a matter of time before laboratory professionals went public with concerns and questions. One example is a story published in the June issue of Clinical Chemistry and Laboratory Medicine (CCLM). It was written by Eleftherios P. Diamandis, M.D., Ph.D., FRCPC, who said that most of Theranos’ claims about its clinical laboratory testing technology are exaggerated. That article, “Theranos Phenomenon: Promises and Fallacies,” was published online May 9, 2015, and in print in the June issue.

“The quality of the results are not known since the Theranos system has not been independently evaluated, nor do any published results exist to compare with conventional technologies,” stated Diamandis, the Section Head of Clinical Biochemistry in the Department of Pathology and Laboratory Medicine at Mount Sinai Hospital in Toronto. “New diagnostic tests must be evaluated for their accuracy, precision, specificity, and long-term robustness. Trueness and precision [accuracy] need to be maintained over months or years, and monitored by external quality assurance programs, so that [a] patient’s data can be directly compared over long periods of time. Without independent validation, Theranos technology’s quality and robustness will remain in question.”

Eleftherios P. Diamandis, M.D., Ph.D

Eleftherios P. Diamandis, M.D., Ph.D. (on left), is Section Head of Clinical Biochemistry, Department of Pathology and Laboratory Medicine Mount Sinai Hospital, Professor and Head, Division of Clinical Biochemistry, Department of Laboratory Medicine and Pathobiology, University of Toronto and Biochemist-in-Chief, Laboratory Medicine Program, University Health Network, Toronto Ontario. (Photo copyright the Advanced Center for Detection of Cancer.)

Is Stealth Research Going on Outside of Peer-Reviewed Journals?

In the same issue of CCLM, Mario Plebani, M.D., the CCLM’s Editor-in-Chief, wrote an editorial about the Diamandis article. Plebani noted that this was the first scientific article to explore the diagnostic technology of Theranos. Plebani is a full Professor of Clinical Biochemistry and Clinical Molecular Biology at the School of Medicine, University of Padua, in Italy.

In the editorial, titled, “Evaluating and Using Innovative Technologies: A Lesson from Theranos?”, Plebani wrote, “Diamandis raises serious concerns regarding the Theranos technology, maintaining that the system has not been independently evaluated, and as none of its results have appeared in the literature, it cannot be compared with conventional technologies.” Plebani also is Chief of the Department of Laboratory Medicine at the University Hospital of Padua and Chief of the Center of Biomedical Research.

Earlier this year, John P.A. Ioannidis, M.D., Ph.D., the C.F. Rehnborg Chair in Disease Prevention at Stanford University, was critical of Theranos in an article, “Stealth Research: Is Biomedical Innovation Happening Outside The Peer Reviewed Literature?.” This article was published in the Journal of the American Medical Association, one of the most prestigious peer-reviewed medical journals in the nation. Ioannidis noted that so little has been written about Theranos in peer-reviewed journals that scientists have not had a chance to evaluate the company’s technology.

“Information about Theranos, a privately held biotechnology company that has developed novel approaches for laboratory diagnostic testing, has appeared in The Wall Street Journal, Business Insider, San Francisco Business Times, Fortune, Forbes, Medscape and Silicon Valley Business Journal, but not in the peer-reviewed biomedical literature. As of January 5, 2015, a search in PubMed using Theranos as a search term identified affiliations for only two unrelated articles coauthored by Theranos Inc. employees, although these two reports do not offer insights about their company,” he wrote.

The lack of peer-reviewed publications amounts to “stealth research,” which “creates total ambiguity about what evidence can be trusted in a mix of possibly brilliant ideas, aggressive corporate announcements and mass media hype,” Ioannidis wrote. Addressing the issue of increased use of stealth research by emerging companies, Ioannidis added that, “unless stealth research adopts more scientific transparency, investors, physicians, patients and healthy people will not be able to judge whether some proposed innovation is worth $9 billion, $900 billion, or just $9—let alone if the innovation will improve the health and well-being of individuals.”

Forbes Says, ‘Technology Remains Shrouded in Mystery’

Just last month, Matthew Herper, who covers biotechnology for Forbes, said he evaluated Theranos by interviewing CEO and founder Elizabeth Holmes and three of the company’s recent business partners and came away more confident about the company than he was previously.

Nevertheless, he could not tell how much is real about the company and how much is hype. “I still have no idea how Theranos’ technology works,” he wrote. He was confident in his research, he said, “But Theranos’ technology remains shrouded in mystery, even controversy, as the company that aims to replace traditional blood tests with mere finger pricks begins to slowly expand from its initial footholds in California and Arizona.”

Theranos has given a reason for its secrecy. In a story published in the New Yorker Magazine in December 2014, reporter Ken Auletta quoted Holmes on why the company choses not to speak about its diagnostic technology. He wrote: “Holmes counters that Theranos is only trying to protect itself from competitors while it tries to do something unique. ‘There isn’t a company that does what we do,’ she told me. ‘We’re creating a new space. We’re in a market for people who don’t like having a needle stuck in their arm.’”

—Joseph Burns

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