Oh no, you're thinking, yet another cookie pop-up. Well, sorry, it's the law. We measure how many people read us, and ensure you see relevant ads, by storing cookies on your device. If you're cool with that, hit “Accept all Cookies”. For more info and to customize your settings, hit “Customize Settings”.

Review and manage your consent

Here's an overview of our use of cookies, similar technologies and how to manage them. You can also change your choices at any time, by hitting the “Your Consent Options” link on the site's footer.

Manage Cookie Preferences
  • These cookies are strictly necessary so that you can navigate the site as normal and use all features. Without these cookies we cannot provide you with the service that you expect.

  • These cookies are used to make advertising messages more relevant to you. They perform functions like preventing the same ad from continuously reappearing, ensuring that ads are properly displayed for advertisers, and in some cases selecting advertisements that are based on your interests.

  • These cookies collect information in aggregate form to help us understand how our websites are being used. They allow us to count visits and traffic sources so that we can measure and improve the performance of our sites. If people say no to these cookies, we do not know how many people have visited and we cannot monitor performance.

See also our Cookie policy and Privacy policy.

This article is more than 1 year old

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is over, there's no apparent athlete-borne Zika pandemic, and the virus doesn't guarantee a headline, Theranos has withdrawn its emergency application to have the Food and Drug Administration approve its blood test for the virus.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

 

Similar topics

Similar topics

Similar topics

TIP US OFF

Send us news


Other stories you might like