{"id":7348,"date":"2022-03-22T16:00:00","date_gmt":"2022-03-22T16:00:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/3699190_HK99190_0"},"modified":"2022-03-22T16:00:00","modified_gmt":"2022-03-22T16:00:00","slug":"indicaid-covid-19-rapid-antigen-at-home-test-receives-fda-emergency-use-authorization-eua-for-over-the-counter-otc-asymptomatic-non-prescription-use","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=7348","title":{"rendered":"INDICAID COVID-19 Rapid Antigen At-Home Test Receives FDA Emergency Use Authorization (EUA) for Over-the-Counter (OTC), Asymptomatic, Non- Prescription Use"},"content":{"rendered":"\n\n\n
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GARDEN GROVE, Calif.<\/span>, March 23, 2022 \/PRNewswire\/ — PHASE Scientific International, LTD<\/a> (PHASE Scientific), a high-growth biotech company founded by bioengineers from UCLA<\/span>, announces that its INDICAID\u00ae COVID-19 Rapid Antigen At-Home Test (INDICAID\u00ae OTC) received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on March 16, 2022<\/span>. The FDA authorized the test for non-prescription home use in the U.S.<\/p>\n

The INDICAID\u00ae 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.<\/p>\n

The performance of INDICAID\u00ae for professional use was published in a peer-reviewed article<\/span><\/a> in the American Society for Microbiology’s journal, Microbiology Spectrum<\/i>. The piece shares data from a prospective multi-site U.S. clinical study, in which INDICAID\u00ae 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.<\/p>\n

“The professional version of INDICAID\u00ae 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<\/span>, Founder and Chief Executive Officer of PHASE Scientific. “We see the approval of INDICAID\u00ae 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.”<\/p>\n

To learn more about PHASE Scientific and INDICAID\u00ae COVID-19 Rapid Antigen At-Home Test, visit www.PhaseScientificUSA.com.<\/u><\/a><\/u><\/p>\n

About the INDICAID\u00ae COVID-19 Rapid Antigen At-Home Test:
<\/b>www.PhaseScientificUSA.com<\/a> 
<\/u>The INDICAID\u00ae COVID-19 Rapid Antigen At-Home Test is authorized for non- prescription home use. INDICAID\u00ae 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. \u00a7 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.<\/p>\n

About PHASE<\/span> Scientific International LTD:
<\/b>PHASE Scienti\ufb01c is a high-growth biotech company with a mission to inspire a new state of health. Headquartered in Hong Kong<\/span> with locations in Southern California<\/span> and China’s<\/span> Greater Bay Area, PHASE Scientific<\/span> provides novel diagnostic tools and services for cancer and infectious diseases with its proprietary technologies. For additional information, please visit www.PhaseScientificUSA.com<\/a><\/u><\/p>\n

\"Cision\" 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<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

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\u00ae COVID-19 Rapid Antigen At-Home Test (INDICAID\u00ae 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\u00ae COVID-19 […]<\/p>\n","protected":false},"author":8,"featured_media":7349,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-7348","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-business-news"],"yoast_head":"\nINDICAID COVID-19 Rapid Antigen At-Home Test Receives FDA Emergency Use Authorization (EUA) for Over-the-Counter (OTC), Asymptomatic, Non- Prescription Use - My Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/transmediavictoria.net.au\/?p=7348\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"INDICAID COVID-19 Rapid Antigen At-Home Test Receives FDA Emergency Use Authorization (EUA) for Over-the-Counter (OTC), Asymptomatic, Non- Prescription Use - My Blog\" \/>\n<meta property=\"og:description\" content=\"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\u00ae COVID-19 Rapid Antigen At-Home Test (INDICAID\u00ae OTC) received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on March 16, 2022. 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