Elizabeth Holmes, the world’ youngest self-made billionaire whose company’s blood testing technology has come under question after a Wall Street Journal article pointed out some inaccuracies in the test’s results.
Holmes, the CEO and founder of Theranos, has since said she “personally was shocked” by The Journal’s article.
The Journal has since published a follow up article saying the company had stopped using its signature finger-prick blood test on all but one of its more than 240 blood tests at the request of government regulators who are looking into the company’s technology.
Before the Journal’s article was published, however, Holmes told Bloomberg that her company was using its proprietary technology on only one test: The one for herpes that was approved by the FDA back in July. Theranos has submitted 130 more tests to the FDA.
“We’ve been transitioning to the FDA system voluntarily,” Holmes told Bloomberg. “As of right now, we’re only using it for the one test,” she said of the Theranos system.
That means the majority of the tests are being done using normal blood draws instead of the finger-prick method that gained Theranos so much attention.
But Holmes’ admission that many of the tests are going through normal testing methods still leaves some questions unanswered. In her quote to Bloomberg where she says “we’re only using it for the one test,” she could be referring to the Edison, Theranos’ proprietary blood processing system, or the nanotainers, her company’s proprietary blood collection system.
Or she could be referring to both.
On Thursday, Holmes told CNBC’s Jim Cramer that, as far as the nanotainers go, those are only being used for the one test that’s been approved by the FDA. “We recently just took our nanotainers through the FDA clearance process and sent submissions in for those and as part of that process, we’re not even using our nanotainers except for FDA-cleared assays so that every single thing that runs on our platform is getting to the point that it’s going to be FDA cleared.”
Even then, however, not using the nanotainers doesn’t mean Theranos isn’t using the Edison processing system, or collecting finger-prick samples with other collection methods. And without a clear timeline, it’s hard to know what “as of right now” means: Holmes could be referring only to the past few days or much longer.
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