Blood testing startup Theranos is under fire.
A recently-released letter that describes the findings of a Centers for Medicare and Medicaid Services (CMS) inspection of a Theranos laboratory in California last November says that the inspectors found serious deficiencies in several areas of the lab's operation, including one deficiency that poses "immediate jeopardy to patient health and safety."
The CMS report describing the specific deficiencies has not yet been released, so it's still hard to say exactly what the investigation found. Theranos has ten days (from when they received the letter on January 25) to show they have fixed the problems.
And Theranos partner Walgreens just announced that they told the company they must stop using the California lab to process any samples for tests run at Theranos Wellness Centers in Walgreens locations.
Even without the details on what the specific deficiencies entail, experts tell Tech Insider that these "serious deficiencies" look bad for Elizabeth Holmes' company.
"They indicate that the skepticism about the approach Theranos takes that I have expressed in my previous interviews (and that other clinical chemists have also been concerned about) is justified," says Dr. David Koch, former president and current board member of the American Association for Clinical Chemistry and a professor at Emory University.
In April of 2015, Koch told Tech Insider that he was skeptical and had questions about Theranos because they claimed to be running revolutionary blood tests but hadn't ever published studies or data that showed how those tests worked or proved that they were as accurate as traditional tests.
"They have talked about interesting and even impressive new technological developments, but it appears that what it all amounts to is just talk," he says.
Not only are these deficiencies serious, they aren't common, according to Koch — something Tech Insider confirmed by reviewing data on CMS lab inspections.
"These inspection criteria are very stringent expectations but are rather easily met if a laboratory is managed properly," says Koch. "It seems that the Theranos laboratory has not been managed properly, is not being directed by the right people, and is not taking a serious approach to the important service they were supposed to provide to patients."
Koch isn't the only medical professional that feels this way.
Even without knowing the details this kind of language "implies serious infractions that require immediate remedy," Jerry Yeo, director of clinical chemistry laboratories at the University of Chicago, said. "It is highly unusual and rare for a [government-certified] lab to get such a grave warning letter from CMS."
He called it "a very damning letter, but necessary to protect the safety and well-being of patients."
Eleftherios Diamandis, a professor of laboratory medicine and pathobiology at the University of Toronto who has been skeptical about Theranos before, reviewed the letter from CMS and told Tech Insider that this qualifies as "a very serious incident ... which may cause the lab to lose its license."
Still, he was careful to note that it's hard to evaluate accurately without the full report detailing exactly what the deficiencies are.
A "lab usually goes into panic mode to correct the deficiency within 10 days," he said, but it's difficult to know yet whether Theranos will be able to so quickly correct the problems CMS found.
Theranos contests the findings of the report, according to spokeswoman Brooke Buchanan, who said in an email that this survey "does not reflect the current state of the lab" and they they have already "addressed many of the observations during the survey and are actively continuing to take corrective action." The company has already replaced the lab's former director, a dermatologist, with a board-certified pathologist, and emphasized that most tests are processed at its larger lab in Arizona.
At this point, a lot of corrective action will be needed to convince skeptics that Theranos really is offering something new and transformative.
"I am more skeptical than ever," says Koch.
