DiaCarta Receives CE/IVD for its New COVID 19 test that Identifies Delta Plus and New Variants

DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy today announced that its new QuantiVirus™ SARS-CoV-2 Variant Detection Test received the CE/IVD marking and therefore, can now be commercialized within the EU and rest of the world. 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 hybridize 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.

"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," said Aiguo (Adam) Zhang, Ph.D., Founder and CEO of DiaCarta Inc. "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) for this unique and rapid SARS-CoV-2 variant detection test. 

About DiaCarta Inc. 

DiaCarta is a molecular diagnostics company that has developed innovative technologies that transform patient care by providing effective precision diagnostics using liquid biopsy. In addition to its FDA EUA approved QuantiVirus™ SARS-CoV-2 Tests, DiaCarta offers a range of testing services, from single-gene QClamp® qPCR tests to its OptiSeq™ XNA-NGS panels. The company is well positioned as a leader in the new 'liquid biopsy' In Vitro Diagnostics field with high-precision detection of ctDNA. Its novel XNA technology provides high level of sensitivity as it clamps the wild-type sequence and amplifies the mutant target sequence. Using this technology, the company has developed its highly sensitive, early detection ColoScape™ Colorectal Cancer test using blood. Powered by its SuperbDNA™ technology that provides high level of detection by amplifying the signal and requiring no RNA/DNA extraction or amplification, the company has developed its revolutionary RadTox™ test that personalizes radiation therapy, mitigates adverse events, and enhances patient care.