Precision diagnostics developer BillionToOne said it has developed the protocol for a novel COVID-19 test that is accurate and cost-effective enough to fulfill the crush of demand for tests—more than one million testing capacity per day in the U.S. alone.
The BillionToOne COVID-19 test uses different sets of instruments and chemicals from existing COVID-19 tests, which according to the company enables labs to unlock a new set of unused capacity.
BillionToOne’s test is designed to sequence the SARS-CoV-2 genome – making the test extremely sensitive and specific, on par or better than other COVID-19 tests available. Additionally, the test is easily adoptable at any labs with Sanger Sequencers, with minimum training.
“Our mission here at BillionToOne is to remove the fear of th
e unknown by making powerful molecular diagnostics available to all,” BillionToOne Co-Founder and CEO Oguzhan Atay, PhD, said in a statement. “We believe our COVID-19 test can contribute greatly in removing the unknowns from the COVID-19 crisis response.”
The company cited a statistic that more than 10 times the current testing capacity is needed to stop the spread of COVID-19 in the U.S. and other countries. Yet at present, current quantitative PCR (qPCR) methods do not support the testing volume needed for rapid COVID-19 response.
Worse, the sharp surge in demand for the same reagents and instruments have caused multiple bottlenecks in the supply chain, complicating efforts to bring more of the current tests to healthcare providers.
Using patent-pending qSanger spike-in and proprietary machine learning algorithms, BillionToOne’s COVID-19 assay is designed to take advantage of the 30X higher throughput Sanger sequencing capacity (1,536 samples on qSanger at a time vs 48 samples on qPCR at a time).
qSanger technology is designed to enable each Sanger instrument to automatically perform 3,840 tests per day, with hundreds of instruments available from the Human Genome Project alone unlocking capacity for millions more tests per day; it would take 260 instruments to reach 1 million/day testing capacity, according to BillionToOne.
Reagents for the test will be available in two weeks, pending manufacturing of kits and emergency use authorization (EUA) from the FDA, BillionToOne said.
The company added that international laboratories without EUA requirements can start testing immediately by using their own reagents and the BillionToOne’s bioinformatics pipeline.
Atay co-founded BillionToOne with David Tsao, Ph.D., the company’s chief technology officer. The company says its patent-pending QCT molecular counter platform can accurately count DNA molecules to the single-count level.
BillionToOne’s first 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.
Last month, BillionToOne closed on a $15 million follow-on Series A+ funding round. Previous investors Hummingbird Ventures and NeoTribe Ventures led the investment round, with participation from Y Combinator, Libertus Capital, Pacific 8 Ventures, Civilization Ventures, 500 Startups Istanbul, and HOF Capital.
The follow-on round brought the total funding raised by BillionToOne to more than $32.5 million.
“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,” Atay added. “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.”