INDICAID OTC COVID-19 Rapid Antigen At-Home Test Receives FDA EUAPress Release
February 6, 2023
PHASE Scientific’s COVID-19 Rapid Antigen At-Home Test Now Available Across the U.S.—Enabling the American Public to Perform the Test On-Demand
GARDEN GROVE, Calif., March 22, 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 United States.
The INDICAID COVID-19 Antigen At-Home Test is intended for non-prescription self-use and/or as applicable, for an adult lay user testing another aged 2 years or older in a non-laboratory setting. This test is authorized for individuals with symptoms of COVID-19 within the first 6 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. All negative results are presumptive. The INDICAID COVID-19 Antigen At-Home Test is only for in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been FDA cleared or approved.
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 nonprescription 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, view the product pages found here on our PHASE Scientific website.
About the INDICAID COVID-19 Rapid Antigen At-Home Test:
The INDICAID COVID-19 Rapid Antigen At-Home Test is authorized for nonprescription 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 provides novel diagnostic tools and services for cancer and infectious diseases with its proprietary technologies. For additional information, please view additional pages here on our website.
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