INDICAID COVID-19 Rapid Antigen At-Home Test Receives FDA Emergency Use Authorization (EUA) for Over-the-Counter (OTC), Asymptomatic, Non- Prescription Use
GARDEN GROVE,Calif.,March 23,2022 -- PHASE ScientificInternational,LTD(PHASE Scientific),a high-growth biotech company founded bybioengineers from UCLA,announces that its INDICAID® COVID-19 Rapid Antigen At-HomeTest(INDICAID®OTC)received Emergency Use Authorization (EUA) from theU.S. Food and Drug Administration (FDA) on March 16,2022. The FDA authorized thetestfornon-prescription home use in the U.S.
The INDICAID® COVID-19 Rapid Antigen At-Home Test is authorized for non-prescription home use with self-collected shallow nasal samples from individuals aged14 years or older,or adult-collected nasal samples from individuals aged 2 years orolder,with or without symptoms or other epidemiological reasons to suspect COVID-19when tested twice over three days with at least 24 hours (and no more than 48 hours)between tests.
The performance of INDICAID® for professional use was published in a peer-reviewedarticlein the American Society for Microbiology's journal,Microbiology Spectrum. Thepiece shares data from a prospective multi-site U.S. clinical study,in which INDICAID®demonstrated strong performance,accurately identifying 85% of those who werepositive (PPA) and 97% of those who were negative (NPA) for SARS-CoV-2 with self-collected specimens.
"Theprofessional version ofINDICAID® has been widely adopted and utilized in theU.S. to meet a variety of emergency testing needs. From schools,mobile testing sites,urgent care networks,and hospitals," said Dr. Ricky Chiu,Founder and Chief ExecutiveOfficer ofPHASE Scientific."We see the approval ofINDICAID® OTC fornon-prescription home testing to expand the adoption of our product to everyone's daily lifeandfurther supportourfight againstthe pandemic."
To learn more about PHASE Scientific and INDICAID® COVID-19 Rapid Antigen At-HomeTest,visit www.PhaseScientificUSA.com.
About the INDICAID® COVID-19 Rapid Antigen At-Home Test:
www.PhaseScientificUSA.com
The INDICAID® COVID-19 Rapid Antigen At-Home Test is authorized for non-prescription home use. INDICAID® is only authorized for the duration of the declarationthat circumstances exist justifying the authorization of emergency use of in vitrodiagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) ofthe Act,21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revokedsooner.
About PHASEScientific International LTD:
PHASE Scientific is a high-growth biotech company with a mission to inspire a new state of health. Headquartered in Hong Kong with locations in Southern California and China's Greater Bay Area,PHASE Scientific provides novel diagnostic tools and services for cancer and infectious diseases with its proprietary technologies. For additional information,please visit www.PhaseScientificUSA.com
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