BillionToOne, Inc. is a molecular diagnostics company that has developed a single‑molecule next‑generation sequencing platform to enable ultra‑sensitive detection of genetic markers from cell‑free DNA, focusing on prenatal and oncology applications.
The company generates revenue primarily by selling its prenatal and oncology diagnostic tests to healthcare providers and receiving reimbursement from insurance companies, government programs such as Medicare and…
BillionToOne, Inc. is a molecular diagnostics company that has developed a single‑molecule next‑generation sequencing platform to enable ultra‑sensitive detection of genetic markers from cell‑free DNA, focusing on prenatal and oncology applications.
The company generates revenue primarily by selling its prenatal and oncology diagnostic tests to healthcare providers and receiving reimbursement from insurance companies, government programs such as Medicare and Medicaid, and direct patient payments. Its product portfolio includes the UNITY suite for fetal risk assessment, aneuploidy screening, RhD status, and fetal antigen detection, as well as the Northstar Select and Northstar Response tests for cancer therapy selection and tumor burden monitoring.
The company operates through the following segments:
• Prenatal: This segment provides non‑invasive prenatal testing products, including the UNITY portfolio for fetal risk assessment, aneuploidy screening, RhD status, and fetal antigen detection, using cell‑free DNA from a single maternal blood draw.
• Oncology: This segment provides liquid biopsy tests for cancer therapy selection and response monitoring, including Northstar Select for mutation detection and Northstar Response for tumor burden measurement, using blood‑based analysis of circulating tumor DNA.
Within the molecular diagnostics industry, BillionToOne holds a differentiated position due to its proprietary single‑molecule next‑generation sequencing technology, which offers greater sensitivity and multiplexing capability than traditional next‑generation sequencing and digital droplet PCR assays used by competitors such as Illumina (through Verinata), Laboratory Corporation of America Holdings, Myriad Genetics, Natera, and Quest Diagnostics in the prenatal market, and Caris Life Sciences, Foundation Medicine (Roche), Guardant Health, NeoGenomics, and Tempus AI in the oncology market. The company’s competitive advantages include its quantitative counting tokens that enable absolute quantification at the single‑molecule level, a patented technology platform that reduces sequencing costs, and a growing body of clinical evidence supporting its tests as potential standards of care.
The company serves obstetricians‑gynecologists, maternal‑fetal medicine specialists, genetic counselors, and other prenatal care providers for its prenatal tests, and oncologists, cancer treatment centers, and hospitals for its oncology tests. Specific partners and collaborators referenced in the filing include Johnson & Johnson, Allegheny Health Network, the University of California San Diego, the University of Florida, the University of Miami, and the Fred Hutchinson Cancer Center.
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Sector: Healthcare Industry: Diagnostics & Research CIK: 0002070849