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Earnings

BillionToOne Raises 2026 Revenue Outlook After Third-Quarter Sales

Third-quarter revenue reached $123.0 million as the diagnostics company lifted full-year 2026 guidance to $460 million to $470 million.

BillionToOne, Inc. (BLLN), a next-generation molecular diagnostics company, reported third-quarter 2026 revenue of $123.0 million, up 47% from $83.5 million a year earlier, and raised its full-year 2026 revenue outlook to $460 million to $470 million.

That range implies 51% to 54% growth over 2025 and sits above the $450 million to $465 million band the company had reiterated after the second quarter.

Year-over-year revenue growth had been 84% in the first quarter and 64% in the second. The company said the third-quarter increase was driven by a 25% rise in tests delivered and an 18% rise in overall average selling price.

Prenatal clinical testing, the larger of the two product lines, generated $104.3 million, up 41% from $74.1 million a year earlier. Oncology clinical testing revenue was $17.1 million, 96% higher than $8.7 million a year earlier. Clinical trial support and other services contributed $1.6 million.

The company delivered 206,000 tests in the third quarter, compared with 165,000 a year earlier. Overall average selling price was $589, up 18% from $501.

Gross profit was $87.1 million, for a 71% gross margin, versus 70% a year earlier. BillionToOne said an increase in overall average selling price drove the margin improvement. Overall cost-per-test rose slightly, which the company attributed to faster growth of higher-cost oncology products and a slight increase in prenatal cost per test, partially offset by cost-per-test improvements in both oncology products.

Total operating expenses were $76.1 million, up 56% from $48.8 million a year earlier. Income from operations was $11.0 million, versus $9.6 million a year earlier, for a 9% operating margin. Net income was $17.4 million, or $0.32 a share, compared with $5.7 million, or $0.10 a share, a year earlier.

Free cash flow, defined as cash flow from operations minus capital expenditures, was $8.6 million in the third quarter.

BillionToOne said it expects to operate the business so that it will continue to generate profitability similar to current levels, even with significant continued investments.

Co-Founder and Chief Executive Officer Dr. Oguzhan Atay said the quarter showed rapid growth with continued GAAP profitability and that more clinicians were choosing the company’s tests in both prenatal and oncology.

The company also cited published clinical evidence. In August, peer-reviewed data in The Green Journal (Obstetrics & Gynecology) validated Unity Fetal Risk Screen as a first-line prenatal screen, with 94.4% sensitivity and 99.5% specificity in a prospective study of nine U.S. institutions. In October, a head-to-head comparison of Northstar Response with a tumor-informed assay in patients on active treatment for advanced cancer showed the two assays agreed on the direction of ctDNA change in 94% of sequential pairs.

BillionToOne announced the upcoming launch of Northstar Clear, a tissue-free MRD test for patients with all solid tumors, commercially available December 15, 2026. The company said its pan-cancer, blood-only design makes it available on day one for all solid tumors, and that initial data in colorectal cancer will show head-to-head performance against a tumor-informed assay.

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