BillionToOne

BillionToOne is a biotechnology company specializing in the development of advanced prenatal and oncology diagnostic testing. Founded in 2016, the company’s mission is to remove the fear of the unknown by transforming how genetic information is detected and understood.

BillionToOne is redefining molecular diagnostics through its proprietary single molecule next-generation sequencing (smNGS) platform, which enables the detection and precise quantification of genetic targets with single-molecule sensitivity — a feat once considered impossible. At the core of this breakthrough lies BillionToOne’s patented Quantitative Counting Templates (QCTs), allowing measurements at the physical limit of detection — a single DNA molecule. This innovation addresses one of healthcare’s key challenges: detecting rare yet clinically significant disease signals in cell-free DNA (cfDNA).

The company uses its smNGS platform to design both prenatal and oncology products that deliver actionable clinical insights from a simple blood draw. These products are reshaping the way diseases are diagnosed and managed, marking a paradigm shift in personalized medicine. BillionToOne’s AI-enhanced, integrated workflow further extends the potential of its smNGS technology, positioning the company to fulfill the promise of non-invasive liquid biopsy — a market estimated at over $100 billion annually in the United States alone.

In 2019, BillionToOne launched UNITY, the company’s first non-invasive prenatal testing (NIPT) platform, which eliminates the need for a paternal sample. UNITY uses cfDNA to assess fetal risk for recessive conditions such as sickle cell disease (SCD) and cystic fibrosis (CF), avoiding invasive procedures like amniocentesis. Since its introduction, BillionToOne has established itself as a leader in the prenatal testing market, expanding UNITY into a comprehensive suite that meets a wide range of prenatal genetic testing needs from a single maternal blood draw.

In 2023, BillionToOne expanded its portfolio into oncology with the launch of two pan-cancer liquid biopsy assays — Northstar Select and Northstar Response.

• Northstar Select guides therapy selection and has demonstrated the ability to detect over 50% more actionable solid tumor mutations than traditional liquid biopsies.

• Northstar Response is designed to monitor treatment efficacy and disease progression in real time.

Through its pioneering technology, BillionToOne is driving the future of precision medicine, enabling earlier detection, more informed treatment decisions, and better patient outcomes.