BillionToOne Reports Third Quarter 2026 Results and Raises 2026 Revenue Guidance

MENLO PARK, Calif., Nov. 04, 2026 (GLOBE NEWSWIRE) -- BillionToOne, Inc. (NASDAQ: BLLN), a next-generation molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, today reported its financial results for the third quarter ended September 30, 2026 and raised guidance for full year 2026.

Financial Highlights: * Total revenue of $123.0 million in the third quarter of 2026, compared to $83.5 million in the third quarter of 2025, an increase of 47%. * Prenatal clinical testing revenue was $104.3 million in the third quarter of 2026, an increase of 41% from the third quarter of 2025. * Oncology clinical testing revenue was $17.1 million in the third quarter of 2026, 96% higher than the $8.7 million reported in the third quarter of 2025. * Gross profit margin was 71% in the third quarter of 2026, compared to 70% in the third quarter of 2025, a one percentage-point increase year-over-year. * 206,000 tests delivered in the third quarter of 2026, compared to 165,000 tests delivered in the third quarter of 2025, an increase of 25%. * Income from operations of $11.0 million in the third quarter of 2026, compared to income from operations of $9.6 million in the third quarter of 2025. * Free cash flow, defined as cash flow from operations minus capital expenditures, was $8.6 million in the third quarter of 2026. * Raising 2026 full year revenue guidance to be in a range of $460 million to $470 million, which represents 51% to 54% growth over 2025. * Expects to operate the business such that it will continue to generate profitability similar to current levels, even with significant continued investments. Recent Operating Highlights: * Today, we announced the upcoming launch of Northstar Clear, a tissue-free MRD test for patients with all solid tumors, which will be commercially available on December 15, 2026. Its pan-cancer, blood-only design makes it available on day one for all solid tumors, and initial data in colorectal cancer will show head-to-head performance against a tumor-informed assay. * In October 2026, we announced peer-reviewed data published in The Journal of Liquid Biopsy from the first head-to-head comparison of Northstar Response with the most widely used tumor-informed assay in patients on active treatment for advanced cancer. The two assays agreed on the direction of ctDNA change in 94% of sequential pairs (67 of 71), and in all four divergent cases clinical records supported Northstar Response’s findings. * In August 2026, we announced peer-reviewed data published in The Green Journal (Obstetrics & Gynecology) validating Unity Fetal Risk Screen as a first-line prenatal screen. The study is the first and largest prospective study of Unity Fetal Risk Screen in its intended-use population and was conducted in collaboration with nine U.S. institutions, demonstrating 94.4% sensitivity and 99.5% specificity. “Our third quarter was another period of strong execution,” said Dr. Oguzhan Atay, Co-Founder and CEO of BillionToOne. “We delivered rapid growth with continued GAAP profitability, and more clinicians are choosing our tests in both prenatal and oncology. This quarter we also strengthened the clinical evidence behind our platform. Published data validated Unity Fetal Risk Screen as a first-line prenatal screen, and Northstar Response delivered strong results in the first head-to-head study of its kind. I am also pleased to announce that next month, we plan to launch Northstar Clear, our MRD test. Overall, we are proud of our performance so far in 2026 and believe we are still in the early chapters of what our platform can achieve.”