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September 8, 2020

BillionToOne secures EUA for RNA extraction-free Covid-19 test

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.

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.

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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.

“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.

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Navigate your business through the ‘new normal’

COVID-19 continues to dominate headlines the world over. It has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities.  Faced with an explosion of conflicting information on how to plan and implement successful recovery strategies, decision-makers are in dire need of a single, reliable source of intelligence.   GlobalData’s COVID-19 Executive Briefing gives you access to unparalleled data and insights to successfully navigate the uncertain road to recovery across the world’s largest industries. Understand every aspect of this disruptive theme by delving into: 
  •  COVID-19 infection update, with statistics on the spread, testing by country, as well as the latest data on vaccines and therapeutic developments 
  • Economic impact overview, covering stock market indices, GDP, unemployment rates, policy responses & GlobalData’s economic recovery scorecards 
  • Sector developments, with access to sector insight summaries, cross-sector indices and the leaders and laggards in each industry vertical 
Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today. 
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