Groundbreaking Solution Enables Enhanced Screening and Genomic Surveillance of SARS-CoV-2 and its Mutations

The first-ever turn-key solution for whole genome sequencing (WGS) of COVID-19 is expected to help hospitals, reference labs, public health organizations and epidemiologists more easily identify and trace all strains of SARS-CoV-2.

Clear Labs (San Carlos, CA, USA), provider of the only fully-automated next-generation sequencing (NGS) platform for turnkey diagnostics, has launched Clear Dx WGS, the first automated WGS solution that determines the complete RNA sequence of the SARS-CoV-2 genome in less than 24-hours, a fraction of time, compared with traditional manual WGS workflows, requiring only minutes of hands-on time. The Clear Dx platform is powered by NGS, robotics and cloud-based analytics. As a result, Clear Dx WGS can more easily determine the nature of virus transmission by differentiating virus strains (including flagging super-spreader events), and monitoring mutations, which can lead to variants.

By delivering rapid sequencing of the whole genome, the Clear Dx platform provides fully-automated library preparation and management, including cDNA synthesis, amplification of targets, indexing, and nucleic acid clean-up. It also provides simplified WGS workflow with ~30 minutes hands-on time (i.e. 1-2 human touch points vs. several dozen touch points with existing manual WGS workflows). Additionally, the platform offers faster results - from days to less than 24 hours; improved consistency in sample processing and accuracy of results; and lower labor costs and greater lab productivity.

“This is a pivotal time for our understanding and management of the ongoing COVID-19 pandemic, and better, more accurate intel is critical,” said Jeff Field, Chief Commercial Officer at Clear Labs. “Our platform can identify different subtypes of the SARS-CoV-2 virus based on its genomic fingerprint. We recognize that it’s no longer enough to confirm cases, it’s about understanding the mutations and evolution of the virus, so the virus can be traced and understood. Ultimately, this leads to timely decisions which can be made to keep people safe. With our unique approach that democratizes genomics applications, Clear Dx WGS can quickly identify new subtypes, mutations, and variants to gain real-time clarity into virus transmission, so it's actionable.”

“In addition to WGS, the platform also features the Clear Dx SARS-CoV-2 Diagnostic Assay (EUA approved) which allows labs to perform diagnostic screening and genomic surveillance simultaneously,” added Field. “For the same price of a traditional PCR screening test, our fully-automated targeted NGS assay delivers same-day results and a comprehensive look into the virus - by differentiating positives into genomic subtypes and flagging clinically-relevant lineages or mutations, such as B.1.1.7, B.1.351, L452R, and D614G. Given the evolution of SARS-CoV-2, it's imperative that the market starts to adopt and implement NGS-based testing solutions to ensure that new strains such as B.1.1.7 are not being missed by conventional testing methods.”