BillionToOne gets FDA EUA status for qSanger-Covid-19 assay
Precision diagnostics company BillionToOne has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its RNA extraction-free qSanger-Covid-19 assay.
The company has designed the qSanger-Covid-19 assay to avoid the costly and time-consuming step of RNA extraction.
BillionToOn’s new assay applies a different set of instruments and chemicals from existing tests to identify SARS-CoV-2, the virus responsible for Covid-19 disease.
Based on patent-pending qSanger technology, the assay enables to increase testing capacity as a single sequencer holds the capacity to process an average of 4,000 tests per day.
With minimum training by Sanger Sequencers, the BillionToOne’s new Covid-19 assay can be easily conducted at clinical laboratories.
BillionToOne has used Swift Biosciences’ custom manufacturing and distribution expertise to complete the development of its Covid-19 assay kits and started international supply in May.
BillionToOne CEO Dr Oguzhan Atay said: “A critical element of combating COVID-19 and enabling communities and economies to reopen is our ability to deliver widespread, cost-effective diagnostic testing across the United States and globally.”
Brazilian medical diagnostics laboratory DASA is already using new new Covid-19 assay
At present, BillionToOne and Swift Biosciences are working with several clinical laboratories in the US and across the globe to assist them adopt the testing protocol.
Brazilian medical diagnostics laboratory DASA has already started using the company’s new Covid-19 assay.
DASA clinical analysis innovation head Dr Jose Levi said: “The qSanger-COVID-19 allowed us to increase the throughput while using reagents and equipment that do not compete with the RT-PCR needs.”
In August, Accelerate Diagnostics and BioCheck have secured FDA EUA status for the BioCheck SARS-CoV-2 IgM and IgG Combo Test and fully-automated MS-Fast instrument.