BillionToOne, Inc.

BillionToOne is a company that transforms healthcare through molecular diagnostics. The company uses a single molecule next-generation sequencing (smNGS) platform to detect and precisely quantify genetic targets with single-molecule sensitivity. This technology uses patented Quantitative Counting Templates (QCTs) to measure at the physical limit of detection, which is the single DNA molecule. This addresses the challenge of detecting sparse disease signals in cell-free DNA (cfDNA). BillionToOne's technology platform supports prenatal and oncology products, which provide insights from blood draws to aid in disease diagnosis and treatment. The company's smNGS platform technologies, combined with an AI-enhanced integrated workflow, aim to advance non-invasive liquid biopsy. BillionToOne transitioned from an R&D-focused company to a commercial organization. In 2019, the company launched UNITY, its first prenatal product. UNITY is a non-invasive prenatal test (NIPT) that uses cfDNA to assess fetal risk for recessive conditions like sickle cell disease and cystic fibrosis without needing a paternal sample or invasive procedures such as amniocentesis. BillionToOne has become a leader in the prenatal testing market, based on revenue and American College of Obstetricians and Gynecologists (ACOG) practice advisory guidelines, and has expanded its UNITY offering to cover comprehensive prenatal genetic needs from a single maternal blood draw.