BillionToOne Raises 2026 Revenue Guidance as Q3 Sales Rise 47%

BillionToOne Inc. (NASDAQ: BLLN) raised its 2026 revenue guidance to $460 million to $470 million after third-quarter revenue increased 47% year over year to $123.0 million, supported by higher test volumes and average selling prices across its prenatal and oncology businesses. The molecular diagnostics company also remained GAAP profitable and cash-flow positive during the quarter.

Total test volume rose 25% from a year earlier to 206,000, an increase of more than 10,000 tests from the second quarter. BillionToOne attributed the growth to execution, expansion of its field sales force and demand for product enhancements in prenatal testing and oncology.

Overall average selling price, including true-up revenue, increased 18% year over year and 7% sequentially to $589 per test. Excluding true-ups, ASP was $552, reflecting additional payer contracts, higher pricing for RhD noninvasive prenatal testing through its PLA code and a greater proportion of oncology tests.

Prenatal and oncology revenue expand

Prenatal revenue increased 42% year over year to $105.9 million and remained the company’s largest business. Oncology revenue rose 96% to $17.1 million, nearly doubling from the prior-year period.

BillionToOne reported prospective clinical validation for its Unity Fetal Risk Screen in a study published in Obstetrics & Gynecology. Conducted with nine U.S. institutions, the study included outcome data for more than 98% of 2,212 pregnancies and reported sensitivity of 94.4% and specificity of 99.5%.

In oncology, a head-to-head study published in The Journal of Liquid Biopsy compared Northstar Response with a tumor-informed assay in advanced-cancer patients receiving active treatment. The tests agreed on the direction of circulating tumor DNA changes in 94% of sequential sample pairs. The presentation said clinical records aligned with Northstar Response in all divergent cases.

The company plans to commercially launch Northstar Clear on December 15. The pan-cancer, blood-only test is designed for tissue-free minimal residual disease testing across solid tumors. BillionToOne said the product will extend its Northstar platform across early- and late-stage cancer care, alongside Northstar Select and Northstar Response. Initial head-to-head data are in colorectal cancer, with additional evidence generation planned for 2027.

Profitability maintained as oncology mix grows

Third-quarter gross margin was 70.9%, compared with 69.9% a year earlier. Prenatal gross margin was 75%, while oncology gross margin reached 45% before MolDX coverage of Northstar Response.

Cost of goods sold per test increased to $169 from $161 in the second quarter, primarily because oncology tests represented a larger share of volume and recent product launches had a temporary cost impact. The company said oncology testing costs continued to decline sequentially and Northstar Response was approximately at gross-margin breakeven. Management expects overall cost per test to rise slightly over time as the lower-margin oncology business grows faster.

GAAP operating income was $11.0 million, representing a 9% operating margin. Net income reached $17.4 million, while adjusted EBITDA increased 44% year over year to $22.7 million, equivalent to an 18% margin. The company ended the quarter with $561.5 million in cash and maintained its expectation of GAAP profitability for 2026.

BillionToOne cautioned that its outlook remains subject to risks including dependence on molecular diagnostic test sales, reimbursement and payer coverage, billing and claims processing, commercial adoption of newer tests, laboratory operations, regulatory and legal matters, international trade policies, competition for specialized employees and protection of proprietary technology.