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August 13, 2021

DiaCarta obtains CE-IVD mark for SARS-CoV-2 variant detection test 

The new QuantiVirus test can detect the Alpha, Beta, Gamma, Delta, Delta Plus, Epsilon and Kappa variants.

DiaCarta has obtained CE-IVD mark for its latest QuantiVirus SARS-CoV-2 Variant Detection Test for marketing in the European Union (EU) and other regions.

The test can identify SARS-CoV-2 and concurrently detect and distinguish between all the new mutating variants including the Alpha, Beta, Gamma, Delta, Delta Plus, Epsilon and Kappa variants.

A multiplex quantitative polymerase chain reaction (qPCR)-based test, QuantiVirus can run on generally available qPCR cyclers and does not require costly and time-taking next-generation sequencing (NGS).

The test leverages DiaCarta’s Xenonucleic acid molecular oligomers (XNA)-based molecular clamping technology and has demonstrated improved sensitivity and specificity.

This technology utilises synthetic XNA that combine with target deoxyribonucleic acid (DNA) sequences and can be used as molecular clamps in qPCR.

Furthermore, the XNA firmly and selectively attaches to the wild-type sequences to aid in precisely amplifying only the mutant sequences.

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In April, DiaCarta reported that in a study its XNA-based molecular clamping technology showed superior sensitivity and specificity in the precise amplification of SARS-CoV-2 mutant sequences only by using qPCR.

DiaCarta founder and CEO Aiguo Zhang 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.”

The company is currently seeking an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for the QuantiVirus SARS-CoV-2 Variant Detection Test

Apart from the FDA EUA-approved QuantiVirus SARS-CoV-2 Tests, DiaCarta also has a variety of testing services, including single-gene QClamp qPCR tests and OptiSeq XNA-NGS panels.

Leveraging its XNA technology, the company developed the ColoScape Colorectal Cancer test, which uses blood samples to detect cancer early.

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