SINCE THE WALL STREET JOURNAL published its exposé of Theranos Inc. in October, other media outlets have published the findings of their own investigations into various aspects of the lab company’s practices.
One example is the disclosure by The Wall Street Journal in November that Theranos had an agreement with Safeway to put blood collection and testing centers in 800 Safeway stores. The Journal reported that Safeway had spent $350 million to build the collection and testing facilities needed in these stories, but that Theranos had not delivered the test equipment and collection staff that was its part of the agreement. (See TDR, November 16, 2015.)
Within weeks of this news, Safeway and Sonora Quest Laboratories of Mesa, Arizona, announced that SQL would provide patient service centers in two Safeway stores in Scottsdale and Phoenix. This is apparently a pilot project between the two companies. SQL sees an opportunity to build patient service centers in more of the 80 stores Safeway operates in Phoenix.
On December 2, the Washington Post reported on dealings that Theranos had with the Department of Defense. According to the Post, in 2012, the DOD requested that the FDA conduct a formal inquiry, writing “an official evaluating Theranos’ signature blood-testing technology for the Department of Defense sounded the alarm in 2012 and launched a formal inquiry with the Food and Drug Administration about the company’s intent to distribute its tests without FDA clearance.” The Wall Street Journal raised similar questions about Theranos’ technology and its relationship with the FDA in its reporting this fall.
After the DOD asked about FDA clearance, the Post said that it had reviewed email correspondence showing that Theranos CEO Elizabeth Holmes asked James Mattis, a four-star general with the U.S. Marines, to intervene on the lab company’s behalf.
Holmes asked Mattis to dispel what she called “blatantly false information” about the company and that violating FDA rules was something the company has “never done and of course would never do,” Holmes wrote, the Post reported.
Avoiding regulatory review?
The Post quoted from another mail, writing that, in a message to Mattis, Holmes wrote, “I would very much appreciate your help in getting this information corrected with the regulatory agencies. Since this misinformation came from within DOD, it will be invaluable if this information is formally corrected by the right people in DOD.” Mattis has been a director at Theranos.
The Post further wrote that, “In a statement Theranos gave to the Post, ‘Theranos said the military was interested in modifying its [Theranos’] blood tests for a rugged battlefield environment, a pilot research project that would not have required standard regulatory approval.
But the military reviewer’s concerns apparently were broader than that project and foreshadowed Theranos’s current problems with the FDA.”
Alert pathologists and lab administrators will note the reference by Theranos that the proposed pilot research project involving the DOD “would not have required standard regulatory review.” This could be interpreted as an attempt by Theranos to get its proprietary lab analyzer and diagnostic technology into a setting where it could access real patients before having to submit this technology to the FDA for the agency’s review.
Lab Testing For Military
The Post’s reporting is consistent with what multiple sources within the DOD’s military laboratory organization have told THE DARK REPORT. They say that a meeting took place in early 2013 at a military installation in Maryland. Theranos was there to show a portable lab testing device that it proposed could be used in military labs and in field hospitals.
Individuals who participated at this meeting say that a blood specimen was collected by Theranos at the start of the meeting to demonstrate the device. Several hours later, when the meeting adjourned, the device had been unable to produce test results. These sources say that DOD officials at this meeting also pointed out to the Theranos officials that a 70-pound lab test instrument would not be considered “portable” for military applications.
Given the news coverage that has happened since The Wall Street Journal’s exposé of Theranos published on October 15, one common insight emerges: Theranos has struggled in recent years to demonstrate to third parties that its diagnostic technology can perform to expectations. As Theranos has said, it needs a fingerstick collection, a microspecimen, and a four-hour test result to be a potential disrupter of the clinical lab industry.
CLIA Inspectors Visited Theranos’ Scottsdale Lab
LAST MONTH, the Arizona Republic reported that officials from the Arizona Department of Health Services conducted an inspection on April 2 of Theranos’ lab in Scottsdale. The inspection was done on behalf of the federal Centers for Medicare & Medicaid Services.
Pathologists and lab managers will note that, while the inspectors reported four “deficiencies” at the lab, each one was routine and typical of such inspections in most clinical labs. Theranos told lab inspectors that it expects the Scottsdale lab will run 1.35 million tests annually.
The inspectors cited issues related to proficiency testing, validation of blood sample analyzers, humidity levels outside of acceptable ranges for some instruments, and deficiencies in dating blood-sample collections, the newspaper reported.
In the article, the Republic reported comments from Theranos saying the inspection findings were routine and that all issues were addressed or corrected within days or weeks of the inspection. Also, Theranos said the inspection findings did not reflect the reliability or accuracy of the consumers’ tests, the newspaper added.
Following the Republic’s report, Holmes wrote to the newspaper to say, “The piece wrongly implies that the observations may have impacted the accuracy of testing results when the simple fact, as we explained to the reporter, is that none of the issues that the surveyors identified impacted the accuracy or reliability of tests or patient results, and observations are common to all lab inspections.”
It should be noted that Theranos has acknowledged to various media outlets that, for most of its clinical testing, it is using venous blood specimens and conventional lab analyzers. This is probably what the CLIA inspectors saw during their inspection.