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
INDICAID COVID-19 Rapid Antigen At-Home Test gets FDA EUA. (Credit: Thomas G. from Pixabay)
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.”
Source: Company Press Release