Groundbreaking RNA Extraction-Free qSanger-COVID-19 Assay Secures FDA EUA

By LabMedica International staff writers
Posted on 08 Sep 2020

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A groundbreaking SARS-CoV-2 diagnostic test which eliminates the costly and time-consuming step of RNA extraction has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA).

Most other molecular assays rely on RNA extraction and qRT-PCR. However, the qSanger-COVID-19 assay from BillionToOne, Inc. (Palo Alto, CA, USA) uses a different set of instruments and chemicals from existing tests, enabling labs to unlock a new, unused capacity for the detection of SARS-CoV-2. The test is easily adaptable with minimum training at any laboratories with Sanger Sequencers, which most major clinical laboratories have readily available.

BillionToOne developed the test based on its patent-pending qSanger technology. The test adopts the technology behind the Human Genome Project - Sanger sequencing - for the reliable detection of viral RNA. The approach vastly increases testing capacity as a single sequencer can process an average of 4,000 tests per day - 20 times more than qRT-PCR instruments. BillionToOne's testing method also removes the costly, time-consuming process of RNA extraction, making its tests more cost-effective, highly scalable, and requiring less manpower to conduct. The removal of the RNA extraction process also removes a critical bottleneck in expanding testing capacity across the US. BillionToOne completed the development of its COVID-19 assay kits by utilizing Swift Biosciences' custom manufacturing and distribution expertise and both the companies are currently working together with multiple clinical laboratories in the US and around the world to help them adopt the testing protocol.

"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," said Dr. Oguzhan Atay, CEO of BillionToOne. "With the emergency use authorization of our RNA extraction-free tests, we can now roll out the test in US laboratories in addition to international labs. We're proud to be on the front lines of the effort to confront the coronavirus pandemic and have now unlocked a cost-effective, scalable way to expand testing in all major laboratories."

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BillionToOne, Inc.