The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Twist Bioscience and Biotia’s SARS-CoV-2 Next-Generation Sequencing (NGS) Assay.
The highly sensitive nucleic acid hybridisation capture-based assay is an in vitro diagnostic test for the qualitative detection of the SARS-CoV-2 virus.
It uses nasopharyngeal, oropharyngeal, anterior nasal and mid-turbinate nasal swabs, nasopharyngeal and nasal wash/aspirates, and bronchoalveolar lavage (BAL) samples from people suspected of having Covid-19 by their healthcare provider.
The assay, which includes Twist Bioscience’s SARS-CoV-2 synthetic RNA controls accompanied by the Biotia COVID-DX software, covers the entire virus genome and detects all SARS-CoV-2 strains in specimens with as few as 800 viral copies per millilitre.
Compared with other sequencing methods, which could miss mutations in certain regions, the hybridisation capture-based approach used in this assay increases the number of genetic variants detected.
Twist Bioscience CEO and co-founder Emily Leproust said: “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.
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“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.”
In a separate development, the US FDA granted EUA to LetsGetChecked’s Covid-19 home collection test, which is now available without requiring a prescription.
By eradicating the need for a doctor’s prescription, the EUA increases access to the test for users and organisations alike and allows those without Covid-19 symptoms or suspected exposure to get tested.
LetsGetChecked CEO and founder Peter Foley said: “While the incredible efforts to make vaccinations available to every American by May has generated renewed hope for the future, widespread testing continues to be a critical vehicle for recovery and the reopening of the economy.
“Research shows that the virus can be transmitted and spread by those who show no symptoms, and this authorisation removes another barrier to entry for high-quality testing to a wider population.”