DiaCarta receives CE/IVD marking for variant detection test

DiaCarta, a molecular diagnostics company and developer of oncology tests using liquid biopsy has received CE/IVD marking for its new QuantiVirus SARS-CoV-2 Variant Detection Test. 

This new 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 (S. Africa), Gamma (Brazil), Delta (India), Delta Plus (India), Epsilon (California) and the Kappa (India) variants.

This new multiplex qPCR-based test can be run on commonly available qPCR cyclers, thereby, bypassing the need to perform expensive and time-consuming Next-generation sequencing (NGS). The test demonstrates enhanced sensitivity and specificity and is powered by DiaCarta's proprietary XNA based Molecular Clamping Technology. This technology uses innovative synthetic Xenonucleic acid molecular oligomers (XNA) that hybridise with target DNA sequences and can be employed as molecular clamps in quantitative real-time polymerase chain reactions (qPCR). The XNA tightly bound to the wild-type sequences specifically enables only the mutant sequences to be accurately amplified.

Aiguo (Adam) Zhang, founder and CEO of DiaCarta, said: "Expensive and time-consuming NGS assays are currently the only option to detect new and emerging COVID-19 variants which are causing widespread global alarm, and creating an urgent need for cost-effective testing platforms that can quickly and accurately detect variants. Our new test shows that our XNA technology can do both - precisely detect known and emerging SARS-CoV-2 mutations and provide an expeditious, inexpensive solution for variant surveillance. We are grateful for receiving the CE/IVD mark for this test as it will allow us to bring this test to the large European population to help them in their immuno-surveillance efforts."

DiaCarta is also pursuing an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA).