First Hybridization Capture-Based Next-Generation Sequencing SARS-CoV-2 Assay Receives FDA EUA

The SARS-CoV-2 Next-Generation Sequencing (NGS) Assay, an in vitro diagnostic test, has become the first hybridization capture-based NGS SARS-CoV-2 assay to be granted Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).

Twist Bioscience Corporation (San Francisco, CA, USA) and Biotia, Inc. (New York, NY, USA) have received EUA from the US FDA for the SARS-CoV-2 NGS Assay. The SARS-CoV-2 NGS Assay is an in vitro diagnostic test, a highly sensitive nucleic acid hybridization capture-based assay, intended for the detection of SARS-CoV-2 RNA.


The SARS-CoV-2 NGS Assay has the ability to analyze the entire RNA viral sequence, to determine the presence or absence of the virus. Furthermore, in an optional research-use only (RUO) report the software analyzes the RNA sequence to detect genetic variants and lineages of SARS-CoV-2. The hybridzation capture-based approach utilized in this assay maximizes the number of genetic variants identified, where other sequencing methods may miss mutations in certain regions.

The assay utilizes Twist Bioscience’s unique ability to rapidly develop virus-specific panels through DNA synthesis and Biotia’s comprehensive data analysis software and reporting capabilities. The SARS-CoV-2 NGS Assay was validated on a NextSeq 550 Sequencing System. Because the assay analyzes the full sequence data, the test reduces the likelihood of a false-negative result. In contrast, a majority of SARS-CoV-2 tests based on polymerase chain reaction (PCR) only identify limited genetic markers of the virus.

“While there are many available high-throughput diagnostic tests available for COVID-19, our solution enables clinicians and researchers the ability to sequence and surveil the evolution of mutations in the virus over time and geography. This is especially significant at the moment as more variants are identified that are more contagious,” 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 samples together, providing actionable information that can then be used to inform public health and clinical decisions.”

"As SARS-CoV-2 continues to evolve, the need for insightful research tools leveraging NGS and evolutionary principles has become starkly clear,” commented Niamh O’Hara, Ph.D., CEO and co-founder of Biotia. “This assay also greatly expands testing options in the clinical space, bringing new technology to patients.”


Related Links:
Twist Bioscience Corporation
Biotia, Inc.