Cue Health’s portable, fast COVID-19 test gains FDA emergency approval

Cue Health’s portable, fast COVID-19 test gains FDA emergency approval

Fresh off a $100 million Series C funding spherical, molecular diagnostics startup Cue Health has extra excellent news — it has obtained an Emergency Use Authorization (EUA) for its speedy, point-of-care COVID-19 take a look at. The firm obtained a $13 million grant from BARDA in March to assist it scale its improvement and deployment of speedy diagnostics, and its COVID-19 take a look at is clearly a key focus of that effort given the present pandemic.

Cue’s take a look at is moveable and makes use of an RNA detection technique to substantiate the presence of the particular virus in a affected person’s system utilizing nasal swab samples. The firm says that it may present leads to as little as 25 minutes, and it’s comparatively easy to manage — each components that make it probably very helpful in efforts to scale COVID-19 testing because the pandemic and its ensuing international well being disaster continues.

The Cue Health take a look at comes as a package that features the pattern assortment wand, together with a take a look at cartridge. The cartridge connects to an app on a smartphone and transmits the diagnostic outcomes to that system. Under the phrases of the EUA granted by the FDA, the Cue take a look at may be administered wherever, as long as it’s finished underneath the supervision of a certified healthcare skilled. Cue says it’s looking for further authorizations from the FDA to increase use of the take a look at to incorporate permitting it to be finished in settings together with workplaces, faculties and even in-home use.

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To begin, Cue Health’s COVID-19 take a look at might be rolling out in partnership with “main healthcare establishments,” in line with the corporate, after which from there the plan is to increase it to plenty of further healthcare facility settings. Ultimately, Cue’s purpose is to create a variety of molecular diagnostic testing options for not solely COVID-19, but additionally influenza and different viruses, with the power to flexibly deploy and conduct them in mainly any setting the place they’re wanted.


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