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DiaCarta Molecular Test for SARS-CoV-2, Variants Obtains CE Mark

NEW YORK ─ Liquid biopsy test developer DiaCarta said Thursday it has obtained the CE mark for its QuantiVirus SARS-CoV-2 Variant Detection Test, enabling its use in the European Union and other regions that accept the designation.

This test screens for the SARS-CoV-2 virus and identifies and differentiates between mutating COVID-19 variants of concern, including the Alpha, Beta, Gamma, Delta, Delta Plus, Epsilon, and Kappa variants, and can run on available qPCR cyclers, bypassing the need to conduct NGS testing, DiaCarta said.

The test can also "provide an expeditious, inexpensive solution for variant surveillance," Aiguo Zhang, founder and CEO of DiaCarta, said in a statement.

It leverages molecular clamping technology in which synthetic xenonucleic acid oligomers hybridize with target DNA sequences and become molecular clamps during qPCR. The XNA are tightly bound to wild-type sequences so that only the mutant sequences are accurately amplified, DiaCarta said.

The Pleasanton, California-based company is pursuing a US Food and Drug Administration Emergency Use Authorization for the test, it added.