Twist Bioscience and Biotia Receive U.S. FDA Emergency Use Authorization for First Hybridization Capture-Based Next-Generation Sequencing SARS-CoV-2 Assay

Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, and Biotia, Inc., a company that uses proprietary analytical software for infectious disease diagnostics, today received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the SARS-CoV-2 Next-Generation Sequencing (NGS) Assay.

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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-2.¹ 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.

New mutations in the SARS-CoV-2 virus continue to accumulate and circulate around the world, creating genetic variants of concern that may alter transmissability or vaccine efficacy, including the most recent B.1.1.7, B.1.351, and P.1 lineages initially found in the U.K., South Africa, and Brazil respectively. Especially given these emerging variants, this capture-based method is an important new tool for the identification, sequencing, and surveillance of COVID-19.

According to the World Health Organization’s Genome Sequencing for SARS-CoV-2, published January 8, 2021, “One advantage of using a capture-based approach over a PCR amplicon-based approach is that capture-based approaches can tolerate sequence differences from the probe sequences of 10–20%. This is higher than the mismatch tolerated by PCR, where such a divergence from the primer sequences would result in a high risk of amplicon failure. Capture-based approaches can therefore be used to enrich successfully for relatively divergent SARS-CoV-2 sequences.”