Last week, a Wall Street Journal report exposed the claims of four former company employees, who believe the company’s marketing claims are overselling the value of its technology.
Advertisement
Here’s one of the already-operating Theranos centers in Palo Alto.
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.
She started her comments onstage today by saying the Journal story misunderstood how her company’s technology does what it does.
However, Holmes and her team at Theranos have fired back, providing commentary to support the accuracy of their testing methodology, as well as their ongoing interaction with the FDA in which the company seems to be moving towards approval of more tests.
Right now, Theranos is only collecting finger-prick blood samples for its herpes test, and that’s only being run on the company’s own technology.
The Journal’s expose disputed the company’s claim that it employs revolutionary finger-stick testing that only requires a few drops.
“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 newspaper said.
Theranos has been cleared by United States regulators for one kind of blood test as part of a procedural strategy to expand the line-up of tests from there, according to Holmes.
“I personally in Arizona worked very hard to change the law”, she said.
For example, the release says: “The reporter writes that ‘Lab experts say finger-pricked blood samples can be less pure than those drawn from a vein because finger-pricked blood often mixes with fluids from tissue and cells that can interfere with tests.’ This is misleading: With each FDA filing, Theranos is showing that our finger-stick tests are just as accurate as venous draws, starting with our first FDA clearance this summer”.
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.
“I have a lot of concerns about this information being misrepresented because I care deeply about what the community that we work with understands and any of their questions”, she said in the interview. “We disagree with it”, Ms. Holmes said in the interview.
However, she added that moving away from small blood draws had “nothing to do…with the accuracy or performance” of the technology. “In fact, they reached out to us and we said no to meeting with them”. Her response: “We’ve never met them”. Government officials had told Theranos executives that the FDA considered its “nanotainer”, used to collect blood from fingers, an unapproved medical device, according to the Journal.
Advertisement
“Theranos subsequently posted a lengthy rebuttal to the articles the Journal published last week”. Holmes told Krim she “wish[es] he’d called instead of writing a letter”, and that “they’re abolutely going to follow up”.
