FDA grants yet another EUA for RNA Extraction-Free Covid-19 Assay

BillionToOne Granted FDA Emergency Use Authorization for Groundbreaking RNA Extraction-Free qSanger-COVID-19 Assay

BillionToOne’s unique testing protocol removes costly, time-consuming step of RNA extraction and significantly expands testing capacity

Date of Release: Sept 7, 2020

MENLO PARK, Calif/PRNewswire/ — Today, BillionToOne, Inc., the precision diagnostics company, received Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for their groundbreaking 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 virus that causes COVID-19. 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.

“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.”

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. 

About BillionToOne

BillionToOne, headquartered in Menlo Park, California, is a precision diagnostics company with a mission to make molecular diagnostics more accurate, efficient, and accessible for all. The company’s patent-pending QCT molecular counter platform is the only technology platform that can accurately count DNA molecules to the single-count level. BillionToOne’s flagship product, UNITY, is the first and only noninvasive prenatal screening that tests fetal cell-free DNA for cystic fibrosis (CF) and spinal muscular atrophy (SMA) through a single sample of the mother’s blood. BillionToOne was co-founded by Oguzhan Atay, Ph.D., and David Tsao, Ph.D. For more information, visit www.billiontoone.com.

Inquiries:

For any questions regarding partnership and test adoption, please contact covid19@billiontoone.com. 

For any media inquiries, contact media@billiontoone.com