GREENSBORO, N.C., Aug. 04, 2022 (GLOBE NEWSWIRE) — Qorvo® (Nasdaq: QRVO), a number one international supplier of connectivity and energy options, in the present day introduced that the U.S. Meals and Drug Administration (FDA) has granted emergency use authorization (EUA) for the Qorvo Omnia™ SARS-CoV-2 Antigen Check in Level-of-Care (POC) settings.
The check is allowed for the qualitative detection of nucleocapsid viral antigens from SARS-CoV-2 (COVID-19) in nasal swab specimens from people who’re suspected of COVID-19 inside six days of symptom onset. The check can also be licensed for people with out signs or different epidemiological causes to suspect COVID-19 when examined twice over three days, with at the very least 24 hours and not more than 48 hours between assessments. The FDA beforehand granted an EUA to be used in average and excessive complexity settings resembling laboratories. This EUA considerably expands the marketplace for Qorvo past laboratories to incorporate doctor places of work, pressing care facilities, retail pharmacies, worker well being testing, and some other areas the place CLIA waived assessments might be carried out.
Erik Allen, lately appointed vp of Qorvo and president of Qorvo Biotechnologies, stated, “Because the COVID testing market transitions to an endemic state and the rise within the omicron variant drives decrease viral load, top quality fast testing infrastructure is required in POC settings. The Qorvo Omnia platform gives a singular mixture of efficiency, automated workflow and scalability to serve on-site testing wants in a really environment friendly method.”
The Qorvo Omnia platform makes use of an progressive diagnostic method through the use of excessive frequency Bulk Acoustic Wave (BAW) sensors to attain extremely delicate and particular COVID-19 detection outcomes with a quick turnaround time, in a simple to make use of, self-contained platform. BAW sensor know-how permits low restrict of detection (LOD) ranges just like molecular testing functionality. As viral masses lower significantly with the Omicron variant and sub-variants, low viral load in affected person samples presents challenges for current over-the-counter (OTC) lateral circulate antigen assessments, giving the Qorvo Omnia platform a technological benefit to proceed to precisely detect antigen related to COVID-19 throughout Omicron surges.
The Qorvo Omnia platform demonstrates wonderful efficiency on the LOD (Restrict of Detection) for the comparator PCR methodology. The Omnia platform demonstrated 85% sensitivity (PPA) throughout scientific research to help the gadget Emergency Use Authorization on the Level of Care (POC); this NIH-sponsored research happened within the latter a part of 2021. A separate NIH-sponsored analysis research was carried out throughout Omicron variant circulation firstly of 2022. Throughout this research, Qorvo continued to see exemplary efficiency at 86% sensitivity the place samples had been at or above the LoD of the comparator PCR methodology. In all research, 100% specificity was noticed.
Peter Matos, president and CEO of medical consultancy Traeokos, stated, “Qorvo’s antigen check brings the extent of efficiency my purchasers want in a number of testing eventualities – particularly as testing wants have developed with Omicron variant efficiency challenges.”
For extra info, go to https://www.qorvobiotech.com.
This venture has been funded in entire or partially with Federal funds from the Nationwide Institute of Biomedical Imaging and Bioengineering, Nationwide Institutes of Well being, Division of Well being and Human Companies, underneath Contract No 75N92021C00008.
The Qorvo Omnia SARS-CoV-2 Antigen Check was granted emergency use authorization (EUA) from the U.S. Meals and Drug Administration (FDA) in April 2021 to be used in average and excessive complexity settings and as of July 2022 for Level of Care settings.
The Qorvo Omnia SARS-CoV-2 Antigen Check has not been FDA cleared or accredited. It has been licensed by the FDA underneath an Emergency Use Authorization and testing is proscribed to laboratories licensed underneath the Medical Laboratory Enchancment Amendments of 1988 (CLIA), 42 U.S.C. §263a, to carry out waived, average or excessive complexity assessments. This check has been licensed just for the detection of proteins from SARS-CoV-2, not for some other viruses or pathogens. These assessments are solely licensed during the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic assessments for detection and/or prognosis of COVID-19 underneath Part 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), except the authorization is terminated or revoked sooner.
About Qorvo Biotechnologies
Qorvo Biotechnologies, LLC is an entirely owned subsidiary of Qorvo, Inc. centered on the event of point-of-care (POC) diagnostics options leveraging Qorvo’s progressive BAW sensor know-how.
About Qorvo
Qorvo (Nasdaq: QRVO) provides progressive semiconductor options that make a greater world attainable. We mix product and know-how management, systems-level experience and international manufacturing scale to shortly resolve our prospects’ most complicated technical challenges. Qorvo serves numerous high-growth segments of enormous international markets, together with shopper electronics, good residence/IoT, automotive, EVs, battery-powered home equipment, community infrastructure, healthcare and aerospace/protection. Go to www.qorvo.com to find out how our numerous and progressive workforce helps join, shield and energy our planet.
Qorvo is a registered trademark of Qorvo, Inc. within the U.S. and in different nations. All different emblems are the property of their respective house owners.
| Investor Relations Contact: Doug DeLieto VP, Investor Relations W +1-336-678-7968 |
Media Contact: Brent Dietz Qorvo Director of Company Communications W + 1 336-678-7935 [email protected] |
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