DiaCarta, a precision molecular diagnostics company, has developed a novel test to detect the newest COVID-19 Omicron variant, based on its proprietary XNA technology.
This new multiplex qPCR-based test namely QuantiVirus SARS-CoV-2 Variant Detection Test screens for the SARS-CoV-2 virus and simultaneously identifies and differentiates all the new mutating COVID-19 variants including the Alpha (UK), Beta (South Africa), Gamma (Brazil), Delta (India), Delta Plus (India), Epsilon (California) and the Kappa (India) variants as well as the recently identified Omicron variants. Having obtained CE/IVD marking the company is commercialising this test globally.
The World Health Organisation (WHO) classified a new SARS-CoV-2 variant, the B.1.1.529, as a Variant of Concern and classified it the Omicron variant. To date, this variant is regarded as the most heavily mutated variant of the SARS-CoV-2 virus, exhibiting more than 10 mutations in the Spike protein, compared with two mutations in the Delta variant in the receptor binding domain, that is employed by the virus to initiate contact with host cells.
As the Omicron variant mutations are like those in the Delta variant, the expectation is that it will transmit rapidly across the world.
Ram Vairavan, Ph.D., senior vice president of commercial operations at DiaCarta, said: "We are extremely excited that our proprietary XNA technology has enabled the rapid development of a diagnostic test to identify the Omicron variant that is estimated by the WHO & CDC to be highly mutated, highly transmissible and extremely virulent. Moreover, DiaCarta's novel test can run on commonly available qPCR cyclers, thereby, bypassing the need to perform expensive and time-consuming Next-Generation Sequencing - a huge advantage as this rapid cost-effective solution will be highly beneficial in global surveillance to contain this rapidly spreading variant."
DiaCarta's XNA based Molecular Clamping Technology uses synthetic Xenonucleic acid molecular oligomers that hybridise with only target wild-type DNA sequences. The XNA oligomers act as molecular clamps that by blocking the wild-type sequences, only enables the accurate amplification of mutant sequences using quantitative real-time polymerase chain reactions (qPCR).
Aiguo 'Adam' Zhang, Ph.D., CEO of DiaCarta, said: "DiaCarta's XNA technology is extremely sensitive to detecting point mutations and can be widely applied to multiple diseases. The ability of our test in detecting a new COVID-19 variant validates this multi-prong applicability of DiaCarta's proprietary XNA technology and we look forward to advancing it in many different directions.
"DiaCarta's existing QuantiVirus SARS-CoV-2 Test that has US FDA's Emergency Use Authorisation, targets sequences that are distant from the highly mutated regions frequently detected in the newly emerging variants, which is why this test can reliably detect all newly emerging and existing SARS-CoV-2 variant strains, including the new Omicron variant strain."
