NEW YORK – Twist Bioscience and Biotia said on Wednesday they have been granted Emergency Use Authorization from the US Food and Drug Administration for their SARS-CoV-2 Next-Generation Sequencing assay.
The in vitro diagnostic assay has the ability to analyze the virus's entire RNA genome to detect its presence or absence in nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swab samples, as well as nasopharyngeal wash/aspirates, nasal wash/aspirates, and bronchoalveolar lavage specimens from individuals suspected by their healthcare provider of having COVID-19. The limit of detection is 800 viral copies per milliliter.
Biotia's COVID-Dx software provides a clinically oriented report, including the presence or absence of the virus. An optional research-use only report offers the option to detect genetic variants and lineages.
"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 Leproust, CEO and cofounder 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."
The test, launched as a research-use only assay in November 2020, is the first NGS-based COVID-19 test to use hybridization capture, the firms said in a statement, which "maximizes the number of genetic variants identified, where other sequencing methods may miss mutations in certain regions." Hybridization probes have higher tolerance for sequence differences than PCR primers, the companies explained.
The SARS-CoV-2 NGS Assay and Biotia COVID-DX software are limited to CLIA-certified laboratories. The SARS-CoV-2 NGS Assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the use of the Illumina NextSeq 500/550/550Dx Sequencing System, NGS workflows, and in vitro diagnostic procedures.
The assay incorporates Twist's synthetic RNA controls for SARS-CoV-2.