PHASE Scientific Americas Launches Online Shop for At-Home COVID-19 Tests

GARDEN GROVE, CA, April 25, 2022 — PHASE Scientific Americas (PHASE Scientific), a high-growth biotech company founded by bioengineers from UCLA, announces that its EUA approved INDICAID COVID-19 Rapid Antigen At-Home Test (INDICAID OTC) is now available for non-prescription home use in the United States through its new Shop INDICAID online store, shop.indicaidusa.com.

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. INDICAID has also been confirmed to detect COVID-19 Omicron variants based on an independent evaluation by the National Institutes of Health (NIH) RADx Variant Task Force.

The professional version of INDICAID has been widely adopted and utilized for a variety of emergency testing needs in schools, mobile testing sites, urgent care networks, and hospitals.

“Shop INDICAID lets consumers and their families benefit from the quality of our INDICAID COVID-19 Rapid Antigen test in the comfort of their own home – without a prescription or having to leave their home to purchase it,”said Doug Field, Chief Revenue Officer of PHASE Scientific Americas. “We believe that proactive, at-home diagnostic testing – in concert with point-of-care healthcare provider testing – is an essential element in combatting the spread of COVID-19. The launch of Shop INDICAID is another step in our efforts to expand 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 essential e-commerce infrastructure for commerce, engineered for reliability, while delivering a fast, easy-to-use, secure shopping experience for consumers. For orders over $20, PHASE is offering free shipping direct from its US facilities to the consumers door. Test kits start at $14.98 for a 2-pack.

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. Get additional information about PHASE’s over-the-counter home-use offerings.

About Phase Scientific International LTD:

PHASE Scientific Americas is part of PHASE Scientific International LTD, a high-growth biotech company with a mission to inspire a new state of health. PHASE provides novel diagnostic tools and services for cancer and infectious diseases, like COVID-19, with its proprietary technologies.

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For more information, contact :

MIKE MCCLELLAN
Sales & Marketing Manager
Email: mike.mcclellan@phasesci.com
Phone: 404.388.9692

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