FDA EUA Variant Calling Assay Allows for Sequencing to Inform Patient Treatment
The Assay was developed in 2020, and this expanded authorization builds on the initial EUA that was received in March 2021 for the qualitative detection of the SARS-CoV-2 virus. (Credit: PIRO from Pixabay)
Twist Bioscience Corporation, 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 expanded Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the SARS-CoV-2 Next-Generation Sequencing (NGS) Assay for the qualitative detection, identification and differentiation of SARS-CoV-2 lineages and identification of specific genomic mutations. The Assay was developed in 2020, and this expanded authorization builds on the initial EUA that was received in March 2021 for the qualitative detection of the SARS-CoV-2 virus.
The hybridization capture-based SARS-CoV-2 NGS Assay has the ability to analyze the entire RNA viral sequence, and to determine the presence or absence of the virus. With the expanded authorization, the reporting of the identified and differentiated SARS-CoV-2 genetic mutations and viral lineages (e.g. Delta, Omicron) to clinicians is now authorized, potentially aiding them to direct appropriate clinical management based upon the specific lineage of virus, when clinically indicated.
The authorization also allows for the reporting of individual mutations in patient samples, information that is important to track as the virus evolves and new variants emerge. The hybridization capture-based approach utilized in this assay maximizes the number of genetic variants and mutations that may be 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 transmissibility or vaccine efficacy, including the most recent Omicron (BA.2.12.1, BA.4 and BA.5) variants. The virus will continue to evolve, and we expect that this capture-based assay will serve as an important new tool for viral identification, sequencing, and surveillance. With this expanded EUA, we anticipate that these data will, for the first time, now enable the appropriate treatment of COVID-19.
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.
In a separate report available to clinicians for professional interpretation, previously for research use only but now authorized under the expanded EUA, the full sequence of the virus is identified, and mutations and variant differentiation are reported. The expanded EUA comes at an important time during the pandemic, as we see evidence of the failure of specific monoclonal antibody therapies against Omicron variants. Variant identification, when used in conjunction with patient history and other diagnostic findings, may now aid in selecting appropriate therapeutics. A paper published in Microbiology Spectrum details results of the NGS SARS-CoV-2 Assay with the COVID-DX Solution to detect the virus and its genetic variants.
Source: Company Press Release