Now the Olympics is over, Theranos is withdrawing its Zika test application

Medical unicorn spins FDA concerns as a 'positive interaction'


Now that the Olympics is over, there's no apparent athlete-borne Zika pandemic, and the virus doesn't guarantee a headline, Theranos has withdrawn its emergency application to have the Food and Drug Administration approve its blood test for the virus.

The emergency approval would have let the company pitch its wares as a Zika test kit against less strict FDA requirements.

At the beginning of August – a few days before the start of the Rio Olympic Games – the embattled boss Elizabeth Holmes claimed in front of the American Association for Clinical Chemistry (AACC) that Theranos' latest disruption was a MiniLab relaunch claiming Zika-detection.

As with its previous MiniLab claims, the pitch centred on finger-prick blood samples and a device that doesn't need the infrastructure of a pathology lab.

Now, according to the Wall Street Journal (since it might be paywalled, here's the Reuters summary), its application to the FDA has been pulled, apparently because the FDA complained that some of the tests it submitted in its application happened before patient safeguards were in place.

The company's Dave Wurtz spun the decision as evidence of “our commitment to engage positively with the agency” – something which, since Theranos is operating in the FDA's remit, seems to be non-optional to outsiders.

The Wall Street Journal says the FDA's main concern is that the company conducted some of the Zika tests before it had received any institutional review board had okayed its safeguards – even though it said in a press release at the time of the AACC presentation that it had that approval.

Theranos is currently appealing FDA sanctions that include a ban on Holmes owning or operating a laboratory. ®

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