Theranos has been responding to mounting backlash over its testing technology, with CEO Elizabeth Holmes saying last week that the company would publish data validating the accuracy of its tests after The Wall Street Journal called its business model and testing devices into question. Now Holmes is reaffirming that pledge, promising to boost transparency amid public fallout.
Theranos needs to "do a better job of communicating" information that supports the efficacy of its products, Holmes told Fortune editor Alan Murray at a forum earlier this week. The CEO admitted during her interview with Murray that the company "as of a few weeks ago" was only using one of its finger stick blood tests commercially. But that decision stemmed from Holmes' desire to get FDA approval for its finger prick blood testing, she added.
"Right now, just because of this FDA transition, we are only doing one," Holmes said. "But that doesn't mean we don't have the technology to do them. There's no reason we can't do peer review and publish other statistics."
A few weeks ago, the WSJ published two articles targeting Theranos' proprietary testing technology. One story showed that the Palo Alto, CA-based company's lab device only handled a small fraction of its tests by the end of 2014. Another article said that Theranos stopped collecting tiny vials of blood drawn from finger pricks for all but one of its more than 200 tests after the FDA paid a surprise visit in August and September.
Those visits turned up a host of manufacturing and design issues. "Nanotainers" used and manufactured by the company to collect samples were "uncleared medical devices," the FDA said in its inspection notice. And Theranos should have the devices officially cleared before use, it added. The agency released its Form 483s last week.
Now Theranos is dealing with pushback from partners and consumers. Last month, Walgreens Boots Alliance ($WAB) said that it wouldn't open any new Theranos "wellness centers" until the company answers questions surrounding its technology. The Deerfield, IL-based drugstore chain has Theranos testing centers at 41 stores in Arizona and California. "We're trying to figure out where we are and what we do going forward. We need to understand the truth," a Walgreens official said at the time.
But Holmes is brushing off talk that the companies' partnership could be on the rocks. "They haven't said that to us. We're talking with them. We completed our rollout with them in Phoenix. They've been a great partner with us there," Holmes told Murray.
Original Reading: http://www.fiercemedicaldevices.com/story/theranos-ceo-heeds-call-transparency-proprietary-technology/2015-11-04
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