SINGAPORE - Media OutReach^[1] - 15 December 2021 - ARISTA Biotech Pte Ltd ("ARISTA")^[2], manufacturer of COVID-19 antigen & antibody diagnostics, confirms that its COVID-19 antigen rapid test, which tests for the presence of SARS-CoV-2 virus in clinical specimens, is able to detect the recently identified B.1.1.529 (Omicron) variant.

On 26th November 2021, the World Health Organization (WHO) announced and designated variant B.1.1529 named Omicron, a newly identified variant first identified in Botswana and South Africa, as a Variant of Concern. Early indication suggested this variant may have higher transmissibility and has already spread to over 30 countries in an accelerated manner.

Sequence study of the Omicron variant confirmed that it harbors more than 30 mutations across its genome with the majority of mutations in the Spike protein. The Omicron variant possesses three replacement and one deletion mutations in the N-protein compared to the original viral strain (Table 1).

The ARISTA TM COVID-19 Antigen Rapid Test is designed to identify the presence of SARS-CoV-2 virus in clinical specimens by detecting the nucleocapsid protein (N-protein) in the core of the virus. ARISTA has conducted studies using recombinant variant N-proteins to validate and confirm the ARISTA COVID-19 Antigen Rapid Test is able to detect over 400+ variants, including B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), B.1.617, B.1.617.2 (Delta), AY.1/AY.2/AY.3 (Delta Plus), B.1.617.3, C.37 (Lambda) and B.1.1.529 (Omicron) with similar sensitivities (Table 2).

Our preliminary laboratory results indicate that the sensitivity of the ARISTA COVID-19 Antigen Test remains similar for all variants tested to date - including the Omicron variant. Further performance validation results and clinical studies on the Omicron variant are underway and will be made available in due course.

Letter of Statement

ARISTA™ COVID-19 Antigen Rapid Test is designed to detect the presence of SARS-CoV-2 virus in a clinical specimen by identifying the nucleocapsid protein (N-protein) of SARS-CoV-2 viral antigen and is used as an aid in rapid screening of COVID-19 infection. As the product manufacturer, ARISTA Biotech Pte Ltd ("ARISTA") is responsible for the performance of the product and ensures it can be effective against all key emerging variants.

On 26^th November 2021, the World Health Organization (WHO) announced and designated variant B.1.1529 named Omicron, a newly identified variant from Botswana and South Africa, as a Variant of Concern. Early indications suggest this variant to have higher transmissibility and has already spread through multiple countries in an accelerated manner.

Sequence study of the Omicron variant confirms that it harbors more than 30 mutations across its genome with the majority of the mutations in the Spike protein. The Omicron variant possess three replacement and one deletion mutations in the N-protein compared to the original viral strain.

ARISTA continues to monitor and validate the product's performance against all major emerging variants, and we hereby confirm that the ARISTA^TM COVID-19 Antigen Rapid Test product continue to detect the Omicron variant with no loss in sensitivity.

ARISTA has conducted studies using recombinant variant N-proteins to validate and confirm similar detection sensitivity on B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), B.1.617, B.1.617.2 (Delta), AY.1/AY.2/AY.3 (Delta Plus), B.1.617.3, C.37 (Lambda) and B.1.529 (Omicron).

ARISTA will conduct further molecular validation and field clinical studies to demonstrate the clinical performance of the ARISTA product towards the Delta and Omicron variants. We will continue to monitor the emerging variants and evaluate the performance of ARISTA™ COVID-19 Antigen Rapid Test against new important variants as they emerge.  Further information will be shared when available.

Dr. Eric Tang

Chief Scientific Officer

ARISTA Biotech Pte. Ltd.

1^st December 2021

References

1. ^{^} Media OutReach (www.media-outreach.com)
2. ^{^} ARISTA Biotech Pte Ltd ("ARISTA") (aristabio.com)