First Hybridization Capture-Based NGS Assay for Characterization and Surveillance of SARS-CoV-2 Launched

The launch of the first-ever hybridization capture-based next-generation sequencing (NGS) SARS-CoV-2 assay for characterization and surveillance of the virus could provide an important new research tool for the sequencing and surveillance of COVID-19.

Twist Bioscience Corporation (San Francisco, CA, USA) and Biotia, Inc. (New York, NY, USA) have developed the SARS-CoV-2 NGS Assay, an NGS-based assay for research-use only (RUO). The SARS-CoV-2 NGS RUO Assay is a highly sensitive nucleic acid hybridization capture-based assay used for the detection, characterization, and environmental monitoring of the SARS-CoV-2 virus. It utilizes Twist Bioscience’s unique ability to rapidly develop virus-specific panels by DNA synthesis and Biotia’s comprehensive data analysis software and reporting capabilities.

The SARS-CoV-2 NGS Assay was validated on a NextSeq sequencer and identifies all SARS-CoV-2 nucleic acid sequences, to allow for surveillance of how the genetic sequence of the virus is changing. In addition, the SARS-CoV-2 NGS Assay reports the full sequence of the virus, enabling improved understanding of mutations, genetic variations and the evolution of the virus as it is transmitted.

Biotia presented data from the assay at the Infectious Disease Week (IDWeek) 2020 Annual Meeting that identify 124 genetic mutations not previously described, including 26 in the functionally important spike protein of SARS-CoV-2. The end-to-end solution was validated on 120 clinical samples (60 positive, 60 negative), and confirmed that the SARS-CoV-2 NGS Assay powered by the COVID-DX Software could be used to detect viral RNA in laboratory research settings. It also provided insight into genetic variants to track transmission, identify risk, and predict outcome and therapeutic response.

In contrast, a majority of SARS-CoV-2 tests based on polymerase chain reaction (PCR) only identify limited genetic markers of the virus. A recent study compared the performance of three different commercially available NGS library preparation kits confirming that hybridization capture results in more even coverage across all sequences in a sample when compared to PCR-based NGS assays.

“While there are many available high-throughput diagnostic tests available for COVID-19, our solution provides sequence data that enables researchers the ability to sequence and surveil the evolution of mutations in the virus over time and geography,” said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. “Importantly, while many labs are conducting individual sequencing runs for each patient sample, this assay and the accompanying software provide a way to batch about 100 patient samples together, providing actionable information that can then be used to inform public health particularly as we see second and third waves of COVID escalating.”

"We are fortunate to be in a position where we can devote our time and resources to fight this global pandemic,” added Niamh O’Hara, Ph.D., CEO and co-founder of Biotia. “This novel and insightful COVID-19 solution is an important step to make NGS-based infectious disease surveillance more widely available and to advance COVID-19 research and control."
“This test spans both diagnostic methods and vaccine research,” noted Christopher Mason, Ph.D., co-founder of Biotia, “We believe this end-to-end solution brings needed tools into the fight against COVID-19, as well as pioneering these capture methods for tracking other pathogens in the future.”

Related Links:
Twist Bioscience Corporation
Biotia, Inc.