BillionToOne has received FDA-EUA for their SARS-CoV-2 diagnostic test which eliminates the costly and time-consuming step of RNA extraction.

As opposed to most other molecular assays that rely on RNA extraction and qRT-PCR, BillionToOne’s qSanger-COVID-19 assay uses a different set of instruments and chemicals from existing tests, therefore 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. 

By utilizing Swift Biosciences’ unique custom manufacturing and distribution expertise, BillionToOne completed the development of its COVID-19 assay kits and began international distribution in May. 

DASA, the biggest medical diagnostics laboratory in Brazil, has already adopted BillionToOne’s qSanger-COVID-19 assay.

“Since March 2020, we have experienced a severe shortage of RT-PCR consumables, which is seriously restricting our capacity to provide molecular testing in Brazil. The qSanger-COVID-19 allowed us to increase the throughput while using reagents and equipment that do not compete with the RT-PCR needs. The BillionToOne team gave us support during all steps of the implementation and validation.” said Dr. Jose Levi, Head of Innovation in Clinical Analysis at DASA.

BillionToOne developed the test based on their patent-pending qSanger™ technology. This test adopts the technology behind the Human Genome Project – Sanger sequencing – to the reliable detection of viral RNA. This approach vastly increases testing capacity because 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 BillionToOne’s 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 United States.

BillionToOne and Swift Biosciences are currently working together with multiple clinical laboratories in the US and around the world to help them adopt the testing protocol.