BillionToOne

BillionToOne is a genetic testing and diagnostic company. Their lead product UNITY Fetal Risk Screen is a unique prenatal test that uses fetal cell-free DNA to directly assess fetal risk for aneuploidies and common recessively inherited conditions, such as sickle cell disease, spinal muscular atrophy, and cystic fibrosis, without needing a blood sample from the male partner or amniocentesis. BillionToOne’s oncology liquid biopsy products, Northstar Select and Northstar Response, assist clinicians in selecting appropriate therapies and monitoring treatment responses in late-stage cancer patients. Northstar Select offers a 2-5x lower detection limit compared to other market assays, while Northstar Response is a methylation-based ctDNA assay with 10x the precision of SNV-based assays, validated across various cancer types for evaluating treatment responses in late-stage patients. Over 500,000 patients had received BillionToOne tests as of June 2024.

Key customers and partnerships

In December 2023, BillionToOne entered an agreement with Janssen R&D, a company of Johnson & Johnson, to perform a global clinical trial for severe hemolytic disease. The partnership was expected to leverage BillionToOne's UNITY Fetal Antigen Clinical Trial Assay (CTA) to select suitable participants for its critical Phase III trial in handling severe hemolytic diseases in pregnancy.