Bringing speed to coronavirus testing

MENLO PARK, Calif.—The precision diagnostics company BillionToOne recently announced that it had developed what it says is a highly accurate and cost-effective novel COVID-19 test protocol, one capable of unlocking more than one million testing capacity per day in the United States alone.

“We’ve all seen the impact this pandemic has had on every aspect of our daily lives,” said Dr. Oguzhan Atay, CEO of BillionToOne. “From the loss of lives to the damage to the economy to the strain on the healthcare system, the coronavirus has delivered a crippling blow to the country. We’re honored to be on the front lines of this fight against the pandemic, and we’re certain that this unique technology will help save lives and stop the spread of the virus.”

As the company explains, current 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 have 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 (1,536 samples on qSanger at a time vs. 48 samples on qPCR at a time). According to the company, qSanger technology unlocks each Sanger instrument to automatically perform 3,840 tests per day, and there are hundreds of instruments available from the Human Genome Project alone, enabling increased testing capacity.

The BillionToOne COVID-19 test uses different sets of instruments and chemicals from existing COVID-19 tests, enabling labs to access unused capacity. BillionToOne sequences the virus’ genome—reportedly making the test extremely sensitive and specific, on par with or better than other COVID-19 tests available. The company says the test is easily adoptable at any labs with Sanger sequencers, with minimum training.

“I’m extremely grateful to the hard work and dedication of the BillionToOne team to get this vital resource developed so quickly,” Oguzhan said. “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.”

BillionToOne 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 first product, UNITY, is reportedly the first and only noninvasive prenatal screening that tests fetal cell-free DNA for cystic fibrosis and spinal muscular atrophy through a single sample of the mother’s blood.