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The USA Meals and Drug Administration (FDA) has granted Emergency Use Clearance (EUA) for the COVID-19 Cue Take a look at for dwelling and over-the-counter use (Cue OTC Take a look at, Cue Well being Inc) .
The Cue OTC take a look at is the primary molecular diagnostic take a look at out there to shoppers and not using a prescription.
The Cue OTC take a look at accurately recognized 96% of constructive nasal swab samples from people recognized to have signs and accurately recognized 100% of constructive samples from people with out signs.
The take a look at detects SARS-CoV-2 genetic materials current within the nostrils and delivers leads to about 20 minutes to the person’s good cellular system by way of the Cue Well being app.
When examined, the Cue OTC take a look at accurately recognized 96% of constructive nasal swab samples from people recognized to have signs and accurately recognized 100% of constructive samples from people with out signs.
The take a look at is meant to be used in individuals 2 years of age and older with or with out signs.
“With this permission, shoppers should buy and self-administer one of many easiest, quickest, and most correct exams and not using a prescription,” mentioned Clint Sever, co-founder and chief product officer of Cue Well being, mentionned in a press launch.
“This FDA clearance will assist us enhance affected person outcomes with an answer that delivers central lab testing accuracy, with the pace and affordability wanted to unravel rising world well being points,” he mentioned. he declares.
Cue Well being plans to supply greater than 100,000 single-use take a look at kits per day by this summer season. Dena Prepare dinner, company communications supervisor, mentioned Medscape Medical Information the corporate has but to announce pricing data, however the value can be “comparable” to different value factors and different merchandise in the marketplace.
“The FDA continues to prioritize the supply of extra dwelling testing choices in response to the pandemic,” mentioned Jeff Shuren, MD, JD, director of the FDA’s Middle for Units and Radiological Well being, in an announcement. declaration.
“The COVID-19 Cue Take a look at for Dwelling and OTC use gives entry to correct and dependable exams at dwelling, and not using a prescription. The FDA will proceed to work with take a look at builders to advance efficient testing choices for physicians, clinicians, and the general public, ”he mentioned.
In June, the FDA granted Cue Well being’s COVID-19 take a look at an EUA for medical and point-of-care use.
The take a look at is at present utilized in hospitals, physician’s workplaces, and dental clinics, in addition to faculties, important companies, retirement houses, and different collective care amenities.
The take a look at can also be distributed as a part of a program run by america Division of Protection and america Division of Well being and Human Providers in a number of states.