INDICAID(TM) COVID-19 Rapid Antigen Test Receives Emergency Use Authorization from the U.S. Food and Drug Administration
GARDEN GROVE, Calif., Aug. 10, 2021 /PRNewswire/ -- PHASE Scientific International LTD (PHASE Scientific), a high-growth biotech company founded by bioengineers from UCLA, today announced that its INDICAID™ COVID-19 Rapid Antigen Test (INDICAID) received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on July 29, 2021. The FDA authorized the test for professional use in point of care CLIA-waived settings in the U.S. The test is intended for the qualitative detection of SARS-CoV-2 antigen in individuals suspected of contracting the virus within five days of symptom onset. Anterior nasal swab specimens may be collected by a healthcare provider or self-collected (by individuals 18 years of age or older, under the supervision of a healthcare professional). In regions outside of the U.S., such as Hong Kong, the test is authorized as a consumer self-test.
INDICAID is one of the first rapid antigen tests to enable batch sample collection and testing at the point of care due to its unique sample collection vial which protects the sample throughout the collection and staging process. The design gives healthcare professionals the option of collecting a large number of samples concurrently and then quickly testing the individual samples in batches within a two-hour timeframe. INDICAID requires no special instrumentation and can be performed in 20 minutes on-site with a gentle shallow nasal swabbing vs. the deeper penetration required by other tests.
“The advantages of INDICAID are essential for allowing efficient testing workflows for point of care settings that require high volume screening such as schools, acute and long-term healthcare facilities and community sites,” said Dr. Ricky Chiu, founder and chief executive officer of PHASE Scientific. “We’ve already supplied over two million INDICAID kits across 30 countries worldwide—and are pleased to now begin distribution into the United States pursuant to the Emergency Use Authorization.”
Earlier this month, the performance of INDICAID 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.
“Our test has been globally adopted and utilized to meet a variety of emergency testing needs. From the Hong Kong government using INDICAID for healthcare worker’s weekly screenings to usage across shopping malls, supermarkets and schools worldwide, our rapid test has proved to be both effective and efficient,” continued Chiu. “We see this U.S. emergency use authorization as recognition of the importance of our technology and product quality and we are eager to expand our reach across the U.S. and into other international markets to do our part in helping combat the COVID-19 pandemic.”
To learn more about Phase Scientific and INDICAID, visit: https://us.phasescientific.com/.
About the INDICAID™ COVID-19 Rapid Antigen Test: INDICAID has been authorized by the FDA under an emergency use authorization for in vitro diagnostic and prescription use only. 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. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate complexity, high complexity, or waived tests. This test is authorized for use at the point of care, i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation.
About Phase Scientific International LTD: PHASE Scientific is a high-growth biotech company founded by a team of bioengineers from UCLA. The organization is focused on building tools that empower people by giving them better information about their health. Headquartered in Hong Kong, its footprint includes research and development, manufacturing and distribution in Hong Kong and Southern California and additional offices in mainland China. For additional information, please visit https://us.phasescientific.com/ or email firstname.lastname@example.org.
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SOURCE PHASE Scientific