Scientists had major doubts about $10 billion startup Theranos --  and now it's a full-on crisis

Controversial start-up Theranos captured the business and media world’s attention with its description of a revolutionary new blood test, one that required just a fingerprick instead of a needle in the arm, and one where results would be available within hours.

But while the company opened its first lab testing centres, pulled together a board full of prominent former government officials, and received a valuation that now equals $US10 billion, scientists continued to ask questions about how and whether or not their “revolutionary” technology works.

A new investigative report in the Wall Street Journal today raises more doubts, with former employees reportedly telling the Journal that Theranos was using its new technology, referred to as “Edison,” for only a small fraction of blood tests. One anonymous former employee told the Journal that at the end of 2014, the company ran 15 tests on new technology compared to 190 tests run in a traditional way with a normal needle.

Reporter John Carreyrou writes that some former employees were “leery about the machine’s accuracy” and uncertain about the new technology, “according to the former employees and emails reviewed by The Wall Street Journal.”

These reports don’t mean that the tests don’t work — there’s still a lot we don’t know. Theranos has repeatedly said that they consider FDA approval of their tests (which is not required for tests developed in labs) the “gold standard” for saying they are effective, and they have not published accounts of how their technology works, saying they want to protect their (patented) intellectual property.

While they have received approval for one test and are certified to operate lab testing facilities, the FDA’s assessment of the company’s other tests — 240 are listed on their web site — is still pending.

Theranos disputes the Journal’s account, saying that “the facts to this reporter to prove the accuracy and reliability of its tests” were ignored and that the “sources relied on in the article today were never in a position to understand Theranos’ technology.”

But while no one can definitely say how well this new technology works without actually examining it, the doubts these anonymous former employees raise add to questions raised by multiple experts in the lab testing field who previously spoke to Tech Insider about their concerns.

Earlier this year, Dr. Jerry Yeo, a professor and director of Clinical Chemistry Laboratories at the University of Chicago, questioned whether or not the company could have really developed a new way to run as many tests as they claim to run — even if their new microfluidics-based technology was allowing for some breakthroughs.

“They completely bypassed the traditional process of peer review or publishing in peer-reviewed journals or having peer labs evaluate their product,” Yeo told Tech Insider, saying that he would expect that for medical technology, experts need to see how it works.

“Why haven’t they shown us that information, why haven’t they been willing to publish it, and why haven’t they shown comparisons with existing technology?” Yeo asked.

In the Journal of the American Medical Association, John Ioannidis, a widely respected expert in scientific accountability, questioned how scientists could evaluate biomedical innovation that was happening in the private sphere without being part of the medical literature.

“How can the validity of the claims made be assessed, if the evidence is not within reach of other scientists to evaluate and scrutinize?” Ioannidis wrote.

The issue, as Yeo said, is that medical technology has the potential to save or harm someone’s life, and for that reason, doctors recommending a Theranos test want to be absolutely certain that it works.

Certain sources told the Journal that they stopped sending patients to Theranos labs because they weren’t sure they could trust the results, with one Phoenix doctor claiming that the results returned by Theranos’s lab differed significantly from the same tests run a few days later.

While Yelp reviews are unverified, multiple reviewers note that their Theranos tests were run using traditional labs. “I recently got my own labs here and was surprised to find that many tests require the traditional lab draws,” writes Nicole S about the Palo Alto lab.

In an editorial about Theranos in the journal Clinical Chemistry and Laboratory Medicine earlier this year, Eleftherios P. Diamandis, the head of clinical biochemistry at Mount Sinai Hospital in Toronto, argued that “most of the company’s claims are exaggerated.”

“History teaches us that there are numerous examples of seemingly disruptive technologies in healthcare (and especially in diagnostics) … which later collapsed, due to their inability to deliver the promised goods,” he wrote, noting that the merits and quality of the Theranos technology in particular are difficult to judge.

Again, none of these doubts necessarily mean that Theranos’s tests don’t work, though the latest allegations add further support to the idea that the technology still has a long way to go. Elizabeth Holmes, the company’s founder, tweeted that the new story was “full of falsehoods” and that they offered to show the Journal their technology, but the Journal declined.

Still, the report continues to raise serious questions about the company, and some of those questions will not be answered until more is known about the company’s tests or until the FDA releases the rest of their evaluations.

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