For Speedy Release:

Today, the U.S. Foods and Drug Administration issued an unexpected emergency use authorization (EUA) for the Cue COVID-19 Exam for Household and About The Counter (OTC) Use. The merchandise is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus existing in the nostrils. The take a look at is the first molecular take a look at authorized for at-home use without the need of a prescription.

“The authorization of this new diagnostic exam underscores FDA’s intention to carry on supporting innovation in testing and providing flexibility to examination builders with the aim of rising the availability of precise and responsible checks for all Americans,” mentioned Acting Food and drug administration Commissioner Janet Woodcock, M.D. “The Fda will proceed to increase Americans’ obtain to testing to support us in the struggle versus this pandemic, which has claimed above 50 percent a million life in the United States.”

Cue COVID-19 Examination for Property and In excess of The Counter (OTC) Use test is approved for non-prescription household use for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal (nasal) swab specimens gathered with the Cue Sample Wand. This take a look at is intended for use in grown ups (self-swabbing) or youngsters two a long time of age or older (swabbed by an adult) with or devoid of symptoms or other epidemiological reasons to suspect COVID-19.

The approved test consists of: the solitary-use Cue COVID-19 Test Cartridge, the one-use Cue Sample Wand nasal swab, the Cue Cartridge Reader (used by the Cue Health and fitness Monitoring Method, furnished separately), and the Cue Health and fitness Cell Application (App) that is downloaded onto suitable mobile sensible devices, like a clever mobile mobile phone. The reusable, battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates success immediately to the Cue Health and fitness App in about 20 minutes. The cell application needs men and women to make an account, and in the long term will be updated to include capacity to report exam success as appropriate to general public wellbeing authorities to keep track of disease prevalence.

Cue COVID-19 Check for Dwelling and Above The Counter (OTC) Use correctly discovered 96% of beneficial samples from people today acknowledged to have signs and symptoms and appropriately identified 100% of favourable samples from persons devoid of signs and symptoms. Cue Overall health expects to make a lot more than 100,000 tests per working day by summer 2021.

“The Fda carries on to prioritize the availability of more at-dwelling screening possibilities in reaction to the pandemic,” claimed Jeff Shuren, M.D., J.D., director of the FDA’s Center for Equipment and Radiological Wellness. “Cue COVID-19 Check for Household and More than-the-Counter (OTC) Use provides entry to precise and trusted tests at-home, without a prescription. The Food and drug administration will continue on to perform collaboratively with examination developers to advance helpful screening possibilities for medical professionals, clinicians, and the community.”

The Food and drug administration has licensed a lot more than 330 assessments and selection kits for a wide variety of uses, people and spots to deliver a huge array of take a look at solutions. Fda has also prioritized evaluate and authorization of EUA requests getting into account a variety of factors, as mentioned in the Unexpected emergency Use Authorization of Medical Products and Connected Authorities Advice, these types of as the community well being need to have for the item and the availability of the product, with the objective of growing over-all US tests ability and affected individual accessibility to assessments. The Fda has, for illustration, prioritized critique of EUA requests for assessments where authorization would enhance tests accessibility (e.g., place-of-care (POC) assessments, dwelling collection tests, and at-residence assessments) or would significantly improve tests ability (e.g., exams that minimize reliance on examination supplies and high-throughput, widely distributed exams). Tests with EUA authorization can be identified on our internet site at In Vitro Diagnostic EUAs.

The Fda, an company inside the U.S. Division of Overall health and Human Expert services, shields the public overall health by assuring the protection, usefulness, and security of human and veterinary drugs, vaccines and other biological products and solutions for human use and health-related products. The company also is dependable for the protection and stability of our nation’s food stuff offer, cosmetics, nutritional dietary supplements, items that give off electronic radiation and for regulating tobacco goods.

 

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