In addition, the employees told reporters that proficiency-testing samples gave different results when tested with the company’s Edison machines and with technology from other companies. Krim starts with discussing the claim that Theranos is only using its proprietary technology for its herpes test, which won FDA approval in July. And our recent announcements around what we’re doing with our nanotainer tube have to do only with the tube that we use to collect capillary or finger-stick blood and the decision that we made to take those tubes through the FDA clearance process we’ve submitted all of our filings around those nanotainer tubes. “And now we’re taking it through for use in any combination of tests”. In 2006, she was named one of Inc. magazine’s “30 under 30” for her work with Theranos.
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Founded in 2003 by Elizabeth Holmes, Theranos claimed to have a proprietary platform that could accommodate numerous tests, from genetic analyses and cholesterol checks to scans for STDs and vitamin deficiencies.
Theranos, which has a valuation of $9 billion, promised to shake up medical testing by conducting a wide range of tests with one drop of blood from a finger-stick, rather than the large vial typically collected. The initial premise of the company was that just a single finger prick of blood could yield accurate test results.
“We note that Ms. Holmes sought to challenge the reliability of our sources, but it remains the fact that she doesn’t know from whom the information for our articles was gathered”, the Journal wrote in its statement.
Theranos chief Elizabeth Holmes disputes paper’s expose claiming it’s misleading customers on its blood tests: “We think it was false”. The employee turned down an offer to receive a traditional venous blood draw instead.
“I read what was written in the article”. In response, Holmes claimed the company has not used commercially available machines, but she did acknowledge that the company is not using its technology for all tests because it is holding off while waiting for FDA approval.
Another big question The Journal articles raised was over the practice of diluting blood samples, which extends how much of the sample can be processed. The former White House press secretary used Medium to respond to the article, which described Amazon as a combative organization where almost everyone cries at his or her desk.
But Holmes explained that, “If you have cars driving on a road and I’m going to take everybody from driving on the right side of the road to the left side of the road, the only way to do that is to pause”.
However, she added that moving away from small blood draws had “nothing to do…with the accuracy or performance” of the technology. FDA officials, she said, did an inspection of the Theranos testing process.
According to a statement provided to BioPharma Dive from a Theranos spokesperson: “Theranos’ technology is reviewed by regulators, proven in the field, and praised by leaders in the industry and doctors and individuals that we serve”.
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“Theranos subsequently posted a lengthy rebuttal to the articles the Journal published last week”.
