GARDEN GROVE, Calif.–(BUSINESS WIRE)–April 25, 2022–
PHASE Scientific Americas (PHASE Scientific), a high-growth biotechnology company founded by UCLA bioengineers, announces that its EUA-approved INDICAID® COVID-19 Rapid Antigen Home Test (INDICAID® OTC) is now available for home use without a prescription in the United States through its new Shop INDICAID ® online store, shop.indicaidusa.com.
The INDICAID ® COVID-19 Rapid Antigen Home Test is authorized for home use without a prescription with self-collected shallow nasal specimens for persons 14 years of age or older, or nasal specimens collected by adults from persons aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice in 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 journal of the American Society for Microbiology, Microbiological spectrum. The article shares data from a prospective multi-site clinical study in the United States, 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. INDICAID® has also been confirmed to detect COVID-19 Omicron variants based on independent assessment by the National Institutes of Health (NIH) RADx Variant Task Force.
The professional version of INDICAID ® has been widely adopted and used for a variety of emergency testing needs in schools, mobile testing sites, urgent care networks and hospitals. “Shop INDICAID ® allows consumers and their families to experience the quality of our INDICAID ® COVID-19 Rapid Antigen test in the comfort of their own home – without a prescription or having to leave home to purchase it,” said Doug Field, Chief Revenue Officer of PHASE Scientific Americas. “We believe that proactive diagnostic testing at home – in concert with testing by health care providers at the point of care – is an essential element in the fight against the spread of COVID-19. The launch of Shop INDICAID ® is another step in our efforts to extend the adoption of testing to everyone’s daily life and further support our fight against the pandemic.
PHASE’s Shop INDICAID ® site is built on the Shopify platform. Shopify is a leading provider of business-critical e-commerce infrastructure built for reliability while delivering a fast, easy-to-use, and secure shopping experience for consumers. For orders over $20, PHASE offers free shipping directly from its US facilities to consumers’ doorsteps. Test kits start at $14.98 for a 2-pack.
About the INDICAID® COVID-19 Rapid Antigen Home Test:
The INDICAID ® COVID-19 Rapid Antigen Home Test is licensed for home use without a prescription. INDICAID ® is authorized only for the duration of the declaration of the existence of circumstances justifying the authorization of emergency use of in vitro diagnostic tests for the detection and / or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 USC § 360bbb-3(b)(1) unless the authorization is earlier terminated or revoked. For more information on PHASE’s over-the-counter home use offerings, see https://us.phasescientific.com/indicaid-otc-rapid-antigen-test/
About PHASE Scientific International LTD:
PHASE Scientific Americas is part of PHASE Scientific International LTD, a high-growth biotechnology company whose mission is to inspire a new state of health. PHASE provides new diagnostic tools and services for cancer and infectious diseases, such as COVID-19, with its proprietary technologies. For more information on PHASE, see https://us.phasescientific.com
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KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA
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SOURCE: PHASE Scientific International LTD
Copyright BusinessWire 2022.
PUBLISHED: 04/25/2022 1:12 PM / DISK: 04/25/2022 1:12 PM
Copyright BusinessWire 2022.