The company, once valued at $9 billion, is shifting its focus to a portable ‘lab on chip’ virus-detection box after its blood-testing business, once labeled revolutionary, came under repeated fire for unreliable results, questionable methodology and inadequately trained staff.
The Journal reported that Theranos testing lab in Scottsdale, Arizona, was found to have “deficiencies” when representatives from The Centers for Medicare and Medicaid Services visited for an inspection last fall. However, Theranos failed to report this instance to investors and others. The startup shuttered its other lab in California last year after it failed a similar test. It also made layoffs in October and then again in January, leaving just 220 employees on staff, and is facing a lawsuit from former partner Walgreens and past patients.
“After months of careful consideration, and prior to CMS’s unannounced inspection in Arizona, Theranos decided to close its laboratories,” Theranos general counsel David Taylor said in a statement.
On the subject of previous patient tests, a number of which have been found to be inaccurate, Taylor said: “Theranos has been responding to the deficiencies raised by CMS and will continue the process of revising or voiding test results as appropriate until we are satisfied that we have taken all necessary remedial action.”
The Journal reported that this latest investigation happened in September. The Arizona lab then shut down in October, according to the company, so it remains unclear why the company took so long — in fact until the Journal’s report was released — to announce the failed inspection of its lab. In an effort to seemingly throw some positive spin on the situation, earlier today (Tuesday) the company announced the creation of a technology advisory board in a move aimed at salvaging its reputation.
With the labs under review and its methodology in the spotlight, Theranos has moved its efforts to its “miniLab” project, a machine that aims to create a portable lab. It was initially aimed at detecting the Zika virus, however, Theranos voluntarily halted tests on the virus after an FDA report found that it did not include proper patient safeguards.
The company plans to push miniLab to doctors and other healthcare professionals, but, according to the many experts in the industry we’ve spoken with, there is little to differentiate the product with what is already on the market.
[18/01/07 01:09 am] Article updated to correct that Walgreens is suing Theranos.
[19/01/07 2:50 pm] Article updated to correct in the sixth paragraph that Theranos had not previously announced the failed Arizona lab inspection.