But beyond its glossy public image, its work may not live up to the rapturous press coverage and billions of dollars in fundraising.
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Theranos is in a period of transition where the company is “converting our entire lab infrastructure to one that is regulated by the FDA”, Holmes said. The company began to do many of its tests in a traditional way using needles instead of using their new fingerprick technology so that they could offer many more expensive, specialized tests for a far cheaper price, she said, adding that they’ve stated that throughout 2015. The rest are done on traditional machines.
Theranos on Thursday defended the quality of its products and services, saying its blood tests have worked for “tens of thousands of satisfied customers through millions of tests” and passed muster with regulators.
However the company also has critics, as The Wall Street Journal ran an article about Theranos alleging that the company’s proprietary testing devices may be inaccurate. It states that former employees were concerned about the accuracy of Edison results, particularly when directly compared against results from another machine. A senior employee told the publication that the company was only running 15 of the tests it offers on its proprietary Edison machine as of December 2014; it was processing 60 more on traditional machines by diluting the drop of blood it collects through fingerprick. There have been complaints from physicians as well, including a few cited by the Wall Street Journal.
In a blog post today, Theranos has vehemently denied the claims outlined by the WSJ, calling the article “factually and scientifically erroneous and grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents”.
The company also claimed in the statement that it provided the Journal with more than 1,000 pages of documents that disprove the allegations. We received our first FDA clearance this summer based on the very proprietary systems the story is asserting don’t work, and have submitted nearly 130 pre-submissions at FDA for tests run on those proprietary systems.
Stories like this come along when you threaten to change things, seeded by entrenched interests that will do anything to prevent change, but in the end nothing will deter us from making our tests the best and of the highest integrity for the people we serve, and continuing to fight for transformative change in health care.
After those people spoke to the Journal, Theranos visited a few of them and asked them to sign prepared statements that said the Journal mischaracterized their comments.
It’s tests that use diluted blood that caused the company trouble, though. Already Theranos appears to be tinkering with how it defines itself.
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Under pressure from regulators, laboratory firm Theranos Inc. has stopped collecting tiny vials of blood drawn from finger pricks for all but one of its tests, according to a person familiar with the matter, backing away from a method the company has touted as it rose to become one of Silicon Valley’s hottest startups.
