DiaCarta has reported that its Xenonucleic acid molecular oligomers (XNA) based Molecular Clamping Technology showed superior sensitivity and specificity in precise amplification of SARS-CoV-2 mutant sequences only, by using quantitative real-time polymerase chain reactions (qPCR), in a study.
This technology uses novel synthetic XNA, which hybridise with target wild-type DNA sequences and work as molecular clamps.
Approximately 278 Covid-19-positive samples originating from the San Francisco Bay Area in the US were analysed in the study.
Data showed that the SARS-CoV-2 Spike-gene D614G mutation was identified in 58 of the 139 samples collected in January (41.7%) and 78 of the 139 samples obtained in February (56.1%).
Furthermore, the N501Y mutation was not identified in the samples from January, while seven of the February samples had both the N501Y and D614G mutations.
DiaCarta noted that these results indicate a comparatively new and rampant spread of the UK variant (B.1.1.7) in Northern California.
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This new molecular clamping technology is highly sensitive and specific and can accelerate large scale testing for variants to fight this global pandemic.
DiaCarta R&D senior vice-president and chief technology officer Michael Sha said: “Next-generation sequencing (NGS) has been the standard method of detection for SARS-CoV-2 variants.
“However, the NGS-based assays are expensive, time-consuming and not widely available, thereby limiting their utility in large scale surveillance for SARS-CoV-2 variants.
“This study demonstrates that DiaCarta’s XNA technology can do both – accurately detect known and emerging SARS-CoV-2 mutations and provide a rapid, cost-effective solution for SARS-CoV-2 variant surveillance.”
The company intends to seek an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for this rapid SARS-CoV-2 variant detection test.
DiaCarta’s portfolio has FDA EUA approved QuantiVirus SARS-CoV-2 tests and a variety of other testing services, including single-gene QClamp qPCR tests and OptiSeq XNA-NGS panels.