INDICAID COVID-19 OTC Tests Receive Canada Authorization
Press ReleaseJuly 13, 2023
(GARDEN GROVE, CA) — July 13, 2023 — PHASE Scientific, a fast-growing biotechnology company focused on diagnostic innovation, announces that its successful INDICAID® COVID-19 Rapid Antigen At-Home Test for OTC has been granted Authorization for Importation and Sale from Health Canada.
While no longer at pandemic levels, the Canadian government recognizes that the SARS-CoV-2 virus is still circulating across Canada and worldwide. In 2023, Canada introduced new regulations to accelerate access to COVID-19 medical devices that have an urgent public health need in Canada. It also makes it possible to continue to import and sell COVID-19 medical devices authorized under the interim order. Now, distribution Of PHASE’s INDICAID COVID-19 tests in Canada will be available to institutions, agencies, and consumers in advance of the approaching fall and winter seasons when COVID has been at its highest.
“PHASE is proud to provide our product to millions in Canada, to help them test at home and to provide a rapid treatment pathway,” said Felix Chao, General Manager of PHASE Scientific Americas. “Health Canada completed a thorough assessment of our INDICAID COVID-19 Rapid Antigen At-Home Test for OTC, which will help all Canadians accurately test at-home in advance of the colder months.”
This year, PHASE also tested and validated its INDICAID tests’ ability to detect the multiple variants of COVID-19. This validation was completed is through the Rapid Acceleration of Diagnostics (RADx) initiative launched by the National Institutes of Health (NIH) at Emory University in Atlanta, Georgia. The INDICAID tests were shown to detect COVID-19 variants at lower concentration levels than the competitive products against which it was evaluated.
Health Canada’s authorization decision is based on performance data reviewed under Health Canada’s expedited authorization pathway, Interim Order No. 3. As a part of the authorization process, clinical data gathered from both retrospective remnant samples and prospective clinical studies were included in support of the INDICAID COVID-19 Rapid Antigen At-Home Test for OTC performance against recognized lab based tests.
Get more information about INDICAID COVID-19 Rapid Antigen At-Home Tests.
About PHASE Scientific
PHASE Scientific Americas is a fast growing biotechnology company with a mission to inspire a new state of health. We are committed to providing patients and healthcare providers in the Americas and beyond with innovative diagnostic and data tools that will enable them to access better health information and make better health decisions. An affiliate of PHASE Scientific International, headquartered in Hong Kong, we have strategic offices in Garden Grove, California and Atlanta, Georgia.
About the INDICAID COVID-19 Rapid Antigen At-Home Test
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. Learn more about our INDICAID products.
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