Billiontoone (NASDAQ:BLLN) raised its full-year revenue outlook after third-quarter sales rose 47% from a year earlier, driven by growth in both prenatal and oncology testing. The molecular diagnostics company also reported its fifth consecutive quarter of positive GAAP operating income.
Revenue for the quarter ended Sept. 30, 2026, reached $123 million, up from $83.5 million a year earlier. Net income available to common shareholders was $17.4 million, or 32 cents per diluted share, compared with $1.5 million, or 10 cents per diluted share, in the prior-year quarter.
The company now expects 2026 revenue of $460 million to $470 million, up from its previous range of $450 million to $465 million. Chief Financial Officer Ross Taylor said the revised outlook represents growth of approximately 51% to 54% from 2025 and excludes any potential fourth-quarter true-up revenue, though it includes true-ups already recorded this year.
Testing Growth and Profitability
Prenatal revenue increased 42% year over year to $105.9 million, while oncology revenue rose 96% to $17.1 million. Total test volume increased 25% to approximately 206,000, with sequential growth in both businesses, Chief Executive Officer Ozan Atay said.
The average selling price rose 18% year over year to $589 per test. Excluding true-up revenue, the average was $552, up 15%. Atay attributed the increase to factors including additional payer contracts, higher reimbursement for RhD noninvasive prenatal testing and a growing share of higher-priced oncology tests.
Third-quarter true-up revenue was $7.6 million, compared with $2.8 million in the second quarter and $3.7 million a year earlier. Taylor said the sequential increase primarily reflected progress resolving held claims with one payer. Excluding true-ups, total revenue grew 8% from the second quarter.
Gross margin improved to 70.9% from 69.9% a year earlier. Operating expenses increased 56% to $76.1 million, while operating income rose to $11 million from $9.6 million. The company reported a 9% GAAP operating margin and an 18% adjusted EBITDA margin for the latest quarter.
BillionToOne generated $8.6 million in free cash flow and ended September with $562 million in cash and equivalents. Taylor said the company expects to continue generating profitability similar to current levels while investing in the business.
Northstar Clear Launch and Coverage
BillionToOne plans to commercially launch Northstar Clear, a tissue-free molecular residual disease, or MRD, test, on Dec. 15. Atay said the blood-based test will be available for all solid tumors at launch, with initial head-to-head data against a tumor-informed comparator focused on colorectal cancer.
The company is also conducting studies involving lung and breast cancer and expects additional cancer-type data in 2027. Atay said initial reimbursement submissions could begin with colorectal cancer, although he did not provide a specific timeline.
Atay said the company does not plan to restrict Clear’s launch by indication and expects its cost profile to allow the test to become gross-margin positive as volume grows, even without Medicare coverage. He cautioned that Clear’s revenue contribution in 2027 would be modest.
The existing oncology sales force will sell Clear, Atay said. He also said Medicare coverage for the company’s Northstar Response test could come by year-end, but that the timing remains uncertain.
Clinical Evidence and Health-System Expansion
Atay highlighted a prospective study of the Unity Fetal Risk Screen published in August. The study covered 2,212 pregnancies, with outcomes obtained for more than 98%, and reported sensitivity of 94.4% and specificity of 99.5%, he said.
He also discussed an October publication comparing Northstar Response with a tumor-informed assay in patients receiving treatment for advanced cancer. Atay said the tests agreed on the direction of circulating tumor DNA change in 94% of sequential pairs, while clinical records supported Northstar Response’s findings in the divergent cases.
On prenatal growth, Atay said the company is targeting larger health systems with products including its 130-gene Fetal Risk Screen and Epic Aura integration. He said more than 20 health systems are at various stages of the company’s pipeline, with each potentially representing 2,000 to 5,000 tests per quarter.
Atay cautioned that not all of those systems would come online in the next 12 months. He said health-system sales cycles can last 12 to 24 months, with implementation steps such as electronic medical record integration, legal work and logistics sometimes taking six months to more than a year. BillionToOne has not provided 2027 guidance.
About Billiontoone (NASDAQ:BLLN)
BillionToOne, Inc is a molecular diagnostics company that develops tests designed to provide more sensitive and quantitative genetic information from blood samples. The company’s technology is based on its proprietary Quantitative Counting Template (QCT) platform, which is designed to measure DNA molecules with high sensitivity and support the detection of clinically meaningful genetic signals.
The company’s products include prenatal diagnostic and screening solutions marketed under the UNITY brand.
