Key Highlights

• Q3 2026 Revenue reached $123.0 million, up 47% year-over-year from $83.5 million

• Oncology clinical testing revenue nearly doubled, growing 96% to $17.1 million

• The company raised full-year 2026 revenue guidance to $460–$470 million, representing 51%–54% growth

• BillionToOne delivered 206,000 tests in Q3 2026, a 25% increase from the prior-year period

BillionToOne Inc(NASDAQ:BLLN), a Menlo Park, California-based molecular diagnostics company, reported its third quarter 2026 financial results on November 4, 2026, showcasing accelerating growth across its testing platforms. The company specializes in prenatal clinical testing, oncology diagnostics, and precision medicine, with a mission to make advanced molecular testing accessible to all patients.

Revenue and Testing Volumes Accelerate

Total revenue for Q3 2026 reached $123.0 million, marking a 47% increase from $83.5 million in the same quarter of 2025. Prenatal clinical testing revenue contributed $104.3 million, representing 41% year-over-year growth and continuing to serve as the company's primary revenue driver. The oncology clinical testing segment delivered $17.1 million in revenue, nearly doubling from $8.7 million a year earlier with 96% growth.

Testing volumes reached 206,000 in the quarter, a 25% increase from the 165,000 tests delivered in Q3 2025. Gross Profit Margin held at 71%, a one-percentage-point improvement from 70% in the prior-year period, indicating that the company maintained pricing discipline even as it scaled operations.

Operating Performance and Cash Flow

Income from operations came in at $11.0 million for the quarter, compared to $9.6 million in Q3 2025, demonstrating that BillionToOne is generating Operating profits while continuing to invest in growth. Free cash flow, defined as Cash Flow from operations minus capital expenditures, was $8.6 million. The company noted it expects to continue generating profitability at levels similar to the current quarter, even with ongoing Investment in new products and clinical capabilities.

Co-Founder and CEO Dr. Oguzhan Atay characterized the quarter as one of continued execution, with progress across both the prenatal and oncology platforms.

New Product Launches and Clinical Milestones

BillionToOne announced the upcoming launch of Northstar Clear, a tissue-free minimal residual disease (MRD) test designed for patients with all solid tumors. The test will become commercially available on December 15, 2026, and its pan-cancer, blood-only design positions it for day-one availability across all solid tumors. Initial data in colorectal cancer are expected to include head-to-head performance comparisons against a tumor-informed assay.

In October 2026, the company reported peer-reviewed data published in The Journal of Liquid Biopsy from the first head-to-head comparison of its Northstar Response platform with the most widely used tumor-informed assay in patients on active treatment for advanced cancer. The two assays agreed on the direction of circulating tumor DNA change in 94% of sequential pairs, and in all four divergent cases, clinical records supported the Northstar Response findings.

On the prenatal side, peer-reviewed data published in Obstetrics & Gynecology validated Unity Fetal Risk Screen as a first-line prenatal screen. The study, conducted in collaboration with nine U.S. institutions, demonstrated 94.4% sensitivity and 99.5% specificity.

Updated Guidance and What Lies Ahead

BillionToOne raised its full-year 2026 revenue guidance to a range of $460 million to $470 million, representing 51% to 54% growth over 2025. The upward revision reflects the company's expanding testing volumes, the growing oncology segment, and the anticipated contribution from Northstar Clear in the final weeks of the fiscal year. With an increasingly diversified testing portfolio and the MRD market as a new frontier, the company enters 2027 with a broader commercial platform and several pending data readouts that could further validate its diagnostic approach.