 |
GARDEN GROVE, Calif., March 23, 2022 /PRNewswire/ -- PHASE Scientific International, LTD (PHASE Scientific), a high-growth biotech company founded by bioengineers from UCLA, announces that its INDICAID® COVID-19 Rapid Antigen At-Home Test (INDICAID® OTC) received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on March 16, 2022. The FDA authorized the test for non-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 aged 14 years or older, or adult-collected nasal samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when 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-reviewed article in the American Society for Microbiology's journal, Microbiology Spectrum. The piece shares data from a prospective multi-site U.S. clinical study, in which INDICAID® demonstrated strong performance, accurately identifying 85% of those who were positive (PPA) and 97% of those who were negative (NPA) for SARS-CoV-2 with self- collected specimens.
"The professional version of INDICAID® has been widely adopted and utilized in the U.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 Executive Officer of PHASE Scientific. "We see the approval of INDICAID® OTC for non-prescription home testing to expand the adoption of our product to everyone's daily life and further support our fight against the pandemic."
To learn more about PHASE Scientific and INDICAID® COVID-19 Rapid Antigen At-Home Test, 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 declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
About PHASE Scientific 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
View original content to download multimedia:https://www.prnewswire.com/news-releases/indicaid-covid-19-rapid-antigen-at-home-test-receives-fda-emergency-use-authorization-eua-for-over-the-counter-otc-asymptomatic-non--prescription-use-301507603.html
