FDA Expands EUA for Twist Bioscience SARS-CoV-2 NGS Assay

The FDA has expanded its Emergency Use Authorization (EUA) for Twist Bioscience’s SARS-CoV-2 next-generation sequencing assay to include differentiation of SARS-CoV-2 variants and the identification of specific genomic mutations from SARS-CoV-2 positive samples.

The test was first granted an EUA in March 2021 for the qualitative detection of the SARS-CoV-2 virus from nasal, oropharyngeal or bronchoalveolar specimens collected from individuals suspected by their healthcare provider of COVID-19 infection.

Emergency use of the test is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 that meet requirements to perform high complexity tests.