BLLN

BillionToOne, Inc. is a precision diagnostics company developing and commercializing next-generation molecular counting technologies for prenatal, oncology, and molecular diagnostics applications. Headquartered in Menlo Park, California, BillionToOne has pioneered its proprietary Quantitative Counting Template (QCT) technology, which enables highly accurate detection and quantification of extremely rare genetic or molecular events. This breakthrough technology addresses limitations of conventional methods, enabling non-invasive prenatal testing, early cancer detection, minimal residual disease monitoring, and other applications requiring extreme sensitivity and specificity. BillionToOne's lead product is UNITY Screen, a comprehensive non-invasive prenatal test (NIPT) performed on maternal blood that simultaneously assesses risks for common chromosomal abnormalities (such as Down syndrome) and single-gene disorders (such as sickle cell disease and cystic fibrosis) that previously required invasive testing. UNITY represents a significant advancement in prenatal screening by providing actionable information about both chromosomal and monogenic conditions from a single blood draw early in pregnancy. The company is expanding into oncology applications where QCT technology enables highly sensitive detection of circulating tumor DNA for cancer screening, monitoring, and treatment selection. BillionToOne operates CLIA-certified and CAP-accredited clinical laboratories processing patient samples. The company has secured clinical validation, established insurance reimbursement, and is scaling commercial operations to expand market access. The prenatal diagnostics market is substantial with millions of pregnancies annually, while oncology liquid biopsy represents an even larger opportunity. BillionToOne competes with established NIPT providers like Natera, Illumina/GRAIL in oncology liquid biopsy, and other molecular diagnostics companies. Differentiation comes from QCT technology's sensitivity and ability to detect both chromosomal abnormalities and single-gene disorders simultaneously. Success depends on driving clinical adoption, expanding reimbursement, building physician awareness, generating clinical evidence demonstrating improved outcomes, scaling operations cost-effectively, and establishing QCT technology as a differentiated platform across multiple diagnostic applications.