Consumer health care company Theranos Inc. quickly "fell from grace" after a series of Wall Street Journal articles explored the novelty and accuracy of the company's blood testing technology.
In late December 2015, federal regulators began to investigate complaints filed by two former Theranos employees that focused on the company's research and laboratory practices.
One of the complaints stated that employees were instructed by management to carry on blood analysis tests on patients despite "major stability, precision and accuracy issues" of the controversial medical device they use. The second complaint claimed that the herpes study conducted by the company in 2014 had breached research protocols.
By the end of January this year, the U.S. Centers for Medicare and Medicaid Services (CMS) found serious deficiencies in Theranos Inc.'s laboratory in Newark, California. The CMS released a letter saying that the practices performed inside the Newark lab pose immediate jeopardy to the health of patients.
Now, new details have emerged about the extent to which the company placed their patients' lives in danger. An unreleased report obtained by the WSJ suggests that Theranos was aware that their tests were erratic, but still proceeded to send the results to 81 patients.
The report has yet to be made available to the public, but WSJ reporters have already spoken to people who are involved with it. The report claims that Theranos ran a hematology blood test on more than 80 people from April to September last year even though results from quality control checks were unreliable.
However, the blood testing company disputes the number. Dr. Kingshuk Das, the new director of the Newark lab, told Engadget that the actual number of patients was less than 40 and that the company has no reason to believe that the issues have affected the health of patients.
Still, the new report is allegedly more detailed and comprehensive than the CMS summary report in January, and actually expands on the accusations.
According to the WSJ, based on reliable sources, Theranos had "ignored quality-control results for the blood-clotting test that fell short of its own criteria."
Theranos Inc.'s blood-clotting test called "prothrombin time" is designed to measure the length of time it takes for blood to clot, a revolutionary step in the treatment of patients at risk for strokes or blood disorders.
Failure to perform hematology tests can be dangerous for patients who take blood thinners, as too much of these blood thinners can cause fatal bleeding, leaving patients vulnerable to clots and strokes.
The report cited by the WSJ also claims that the Theranos lab sometimes used expired chemicals and reagents in their tests. The CMS said there was a quality control manager unfit for the program.
Dr. Timothy Hamill of the University of California said continuing to test patients despite erratic results in quality control is a serious breach of protocol used by labs to ensure accuracy. Doctors should not depend on the prothrombin time results and should have their patients re-tested, he said.
"Those results are not worth anything," added Hamill.
Meanwhile, representatives from Theranos said the company has already conducted assessments to identify patients affected or potentially affected by the issues.
"At its heart, the CMS report is about people and processes in one Theranos lab in the past, and does not reflect the current state of that lab," the company said.
The company is doing its best to remedy the damage, but it is still facing a long battle ahead as its benefactor Walgreens is planning to end its partnership with the company.
Photo: Steve Jurvetson | Flickr