COVID-19 Omicron EG.5 Variant Update

Phase Scientific continuously monitors emerging variants of the virus that causes COVID-19 and how their mutations may impact the performance of the INDICAID^® COVID-19 Rapid Antigen Test.

An independent evaluation by the National Institutes of Health (NIH) RADx Variant Task Force has determined that the INDICAID test detects the Omicron variant B.1.1.529 and Omicron subvariants BA.2 (B.1.1.529.2) and BQ.1.1 in live clinical samples.

Phase Scientific has also performed in-house analytical testing for the detection of Omicron subvariant nucleocapsid (N) protein. Limiting dilution studies of recombinant N protein from the Omicron sub-variants listed in the table below demonstrated that the INDICAID test achieves a similar level of detection compared to that of the original strain of SARS-CoV-2.

Taken together, our in-house testing and the independent evaluation by the RADx VTF suggest that the N protein mutations of currently circulating Omicron sub-variants, including the recently identified EG.5, XBB.1.5, XBB.1.16, BQ.1 and BQ.1.1, are unlikely to impact INDICAID^® test performance.

“PHASE is always monitoring how we can advance our products to provide the best for our customers,” said Felix Chao, General Manager of PHASE Scientific Americas. “Our testing of both our INDICAID COVID-19 OTC and PoC products allows our customer the peace of mind that they are getting the best product with this ever changing virus.”  

A summary of the expected impact of the various Omicron sub-lineages on the INDICAID^® test performance is presented in the available PDF letter/notice.

About the INDICAID COVID-19 Rapid Antigen At-Home Test:

The INDICAID COVID-19 Rapid Antigen At-Home Test is authorized 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 PHASE Scientific International Americas:

PHASE Scientific is a fast growing biotechnology company dedicated to inspiring a new state of health. We are committed to providing patients and healthcare providers with innovative diagnostic and data tools that will assist them in understanding their health and making better health decisions. The company has its offices in Garden Grove, California and Atlanta, Georgia. For additional information, please visit www.PhaseScientificAmericas.com

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