PATIENT SAFETY

Theranos Has Invalidated Tens of Thousands of Tests

Theranos has invalidated tens of thousands of inaccurate tests run on its proprietary platform and equipment from other manufacturers, the company has confirmed.

Brooke Buchanan, a spokesperson for the Palo Alto, Calif.-based Theranos, said that less than 1 percent of all the tests run by the company have been invalidated or corrected. But out of a total of some 7 million tests performed by the company to date, even a number just below 1 percent would represent 70,000 assays. Buchanan did confirm that the number was in the tens of the thousands. They included some two years of tests performed on its Edison platform that the company claims can perform hundreds of lab tests using just a few drops of blood. She declined to give specific numbers regarding the tests performed on each of the platforms.

Buchanan said the tests were either invalidated or corrected on a case-by-case basis, depending on whether a sample remained extant or other circumstances. Retests are being offered free of charge, she added.

The Wall Street Journal first reported on the invalidated and corrected test issue last month, although Theranos did not confirm that that was the case at the time the newspaper published its story.

Buchanan said the test issue was confined to Theranos’ primary laboratory in Newark, Calif., and did not involve a second facility in Arizona. The company is in the midst of opening a third facility in Pennsylvania, Buchanan confirmed.

The Wall Street Journal has reported that many of the invalidated tests were sent to medical practices in the Phoenix area, where Theranos operates most of its clinics on the sites of Walgreens pharmacies.

Laboratory Industry Report contacted about a dozen medical practices in and around Phoenix, and while clerical staff said they had not been affected, several said they were aware of providers that had been impacted. Those providers did not respond to requests seeking comment.

The issue with the tests and the other storm clouds gathered around the company has raised some doubts about its ability to continue as an ongoing venture. It went from a valuation of $9 billion just a few months ago to the subject of federal probes about the accuracy of its tests and potential criminal investigation regarding whether investors may have been misled about the viability of its technology. A deal with Walgreens to install testing centers at many of its stores has been stalled.

Although other laboratories in the past have had to correct or invalidate tests due to an operational or regulatory issue, the sheer volume in this matter is unprecedented, according to Dennis Weissman, a Washington, D.C.-based laboratory consultant.

“Their reputation has been sullied by exposé after exposé, and given the fact they were so secretive and highly suspect to begin with, I can’t imagine how they can economically move on from this,” Weissman said.

He added that most of the venture capital firms that had previously invested in Theranos had expertise in businesses other than health care and had been looking to diversify. That fact and the tightening of the venture capital market means the company is unlikely to get other funding in the foreseeable future.

Several other sector and compliance experts did not respond to requests seeking comment on the matter.

Buchanan said the company would soldier on.

“We have no concerns. It is business as usual (in the Arizona lab) and we continue to expand the company,” she said.

Takeaway: Theranos’ decision to invalidate or correct tens of thousands of tests casts some doubts on its ability to continue operations as an ongoing venture.

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