Precision diagnostics company BillionToOne has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Covid-19 diagnostic test, which doesn’t require RNA extraction.
Unlike the other molecular assays, which use RNA extraction and qRT-PCR, BillionToOne’s qSanger-Covid-19 assay uses a different set of instruments and chemicals from existing tests.
Developed based on the company’s patent-pending qSanger technology, the test adopts Sanger sequencing for the reliable detection of viral RNA.
The approach scales up the testing capacity 20 times higher than qRT-PCR instruments as a single sequencer can process an average of 4,000 tests a day.
The company noted that the test is easily adaptable with minimum training at laboratories with Sanger Sequencers.
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 US and globally.
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“With the emergency use authorisation of our RNA extraction-free tests, we can now roll out the test in US laboratories in addition to international labs. We are proud to be on the frontlines of the effort to confront the coronavirus pandemic and have now unlocked a cost-effective, scalable way to expand testing in all major laboratories.”
BillionToOne has used Swift Biosciences’ custom manufacturing and distribution capabilities for the development of the assay.
It began the international distribution of qSanger-Covid-19 assay, which is already adopted by Brazil-based medical diagnostics laboratory DASA, in May.
The company and Swift Biosciences are currently working with multiple clinical laboratories in the US and across the world to help them adopt the testing protocol.