The precision diagnostics company BillionToOne has announced a significant development in the struggle against the coronavirus pandemic. BillionToOne has developed a highly accurate and cost-effective COVID-19 test protocol, unlocking more than one million testing capacity per day in the USA alone. Test reagents will be available in two weeks, pending kit manufacture and regulatory approval.
As detailed by leading health professionals, extensive testing – over 10 times the current capacity – is needed to stop the spread of the coronavirus. At the present, quantitative PCR (qPCR) methods do not support the testing volume needed for rapid COVID-19 response. Additionally, the extreme surge in demand for the same reagents and instruments has caused multiple bottlenecks in the supply chain.
Using the patent-pending qSanger spike-in and proprietary machine-learning algorithms, BillionToOne’s COVID-19 assay takes advantage of the 30-times higher-throughput Sanger sequencing capacity (1536 samples on qSanger at a time versus 48 samples on qPCR at a time). qSanger technology unlocks each Sanger instrument to perform automatically 3840 tests per day, and there are hundreds of instruments available from the Human Genome Project alone, unlocking the capacity for millions of tests per day.
The BillionToOne COVID-19 test uses different sets of instruments and chemicals from existing COVID-19 tests, enabling laboratories to unlock unused capacity. BillionToOne sequences the virus genome, making the test extremely sensitive and specific, on par with, or better than, other COVID-19 tests available. Additionally, the test is easily adopted at any laboratory with Sanger sequencers, with minimum training.
Test reagents will be available in two weeks, pending manufacturing of kits and EUA from the FDA. International laboratories without EUA requirements can start testing immediately by using their own reagents and the BillionToOne's bioinformatics pipeline.
"I'm extremely grateful for the hard work and dedication of the BillionToOne team to get this vital resource developed so quickly," said Dr Oguzhan Atay (BillionToOne CEO, pictured). "Our mission here at BillionToOne is to remove the fear of the unknown by making powerful molecular diagnostics available to all. We believe our COVID-19 test can contribute greatly in removing the unknowns from the COVID-19 crisis response."