- Twist Bioscience ( NASDAQ: TWST ), a developer of synthetic DNA-based products and its partner Biotia, Inc. announced on Tuesday that the FDA authorized their product, SARS-CoV-2 Next-Generation Sequencing Assay for the detection of COVID variants and specific gene mutations.
- FDA’s expanded emergency use authorization allows the use of SARS-CoV-2 NGS Assay for reporting of genomic mutations and viral lineages such as Delta, Omicron for the benefit of clinical decision making when indicated.
- The assay developed in 2020 leverages Twist’s ( TWST ) DNA synthesis technology and Biotia’s data analysis software and reporting.
- In March 2021, the FDA issued its initial EUA for the SARS-CoV-2 Next-Generation Sequencing Assay for the qualitative detection of the COVID-19 virus.
For further details see:
Twist Bioscience/ Biotia sequencing assay granted FDA nod to detect COVID variants