BillionToOne, Inc.

BillionToOne, Inc. (Nasdaq: BITO) is a molecular diagnostics company transforming healthcare through its proprietary single-molecule next-generation sequencing platform. The company's website is www.billiontoone.com.

BillionToOne develops ultrasensitive diagnostic tests that detect and precisely quantify genetic targets at the single DNA molecule level, addressing fundamental limitations in traditional next-generation sequencing methods. The company's breakthrough technology centers on Quantitative Counting Templates, patented synthetic DNA fragments that serve as amplification controls, enabling absolute quantification of cell-free DNA with unprecedented precision and sensitivity.

The company operates through two primary product segments: prenatal diagnostics and oncology diagnostics. In prenatal testing, BillionToOne offers the UNITY Complete portfolio, which includes the UNITY Fetal Risk Screen for recessive genetic conditions, UNITY Aneuploidy Screen for chromosomal abnormalities, UNITY Fetal RhD NIPT for blood type incompatibility, and UNITY Fetal Antigen NIPT for red blood cell and platelet antigen detection. These tests provide comprehensive fetal genetic assessment from a single maternal blood draw without requiring paternal samples or invasive procedures. The company launched its first prenatal product in 2019 and has established itself as a leader in this market, with recent American College of Obstetricians and Gynecologists practice advisory updates citing the company's clinical data.

In oncology, BillionToOne offers Northstar Select, an ultrasensitive liquid biopsy test for therapy selection in late-stage cancer patients, and Northstar Response, a methylation-based assay for monitoring tumor burden and treatment response. The company also offers complementary applications including Northstar PGx for chemotherapy safety and Northstar Select CH for clonal hematopoiesis assessment. In 2025, the MolDX Program determined that Northstar Select meets Medicare coverage requirements.

BillionToOne went public on November 6, 2025, with its Class A common stock trading on the Nasdaq Global Select Market. The company has achieved profitability on both income from operations and net income bases while maintaining capital efficiency relative to peers in the molecular diagnostics industry. The company's competitive advantages include its proprietary smNGS platform, category-defining products with superior clinical performance, rapid growth at scale with low customer churn, and superior operational efficiency.