ARISTA Biotech Confirms Antigen Test Effectiveness Against Omicron and other COVID variants

SINGAPORE
– Media OutReach – 15 December 2021 – ARISTA Biotech Pte Ltd
(“ARISTA”), 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 26th 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 ARISTATM 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.

1st December
2021

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