BillionToOne, Inc. reports developments in molecular diagnostics, with news centered on its QCT molecular counting platform, prenatal testing franchise and Northstar oncology liquid biopsy portfolio. Recurring updates cover financial results, revenue guidance, test volumes, product launches and leadership changes tied to the company’s clinical testing operations.
The company’s prenatal news includes UNITY products for non-invasive prenatal testing, fetal antigen testing and Unity Confirm, a circulating fetal cell-based confirmation test. Oncology updates focus on Northstar Select, Northstar Response and add-on liquid biopsy applications such as Northstar PGx and Northstar Select CH for therapy-selection and related clinical insights.
BillionToOne (NASDAQ: BLLN) raised its full-year revenue outlook after reporting third-quarter revenue of $123.0 million, up 47% year over year. The company now expects 2026 revenue of $460 million to $470 million, versus $450 million to $465 million previously, representing 51% to 54% growth.
Prenatal revenue rose 41% to $104.3 million, while oncology revenue increased 96% to $17.1 million. Tests delivered grew 25% to 206,000, and average selling price rose 18% to $589. Gross margin increased to 71% from 70%. Operating income reached $11.0 million, versus $9.6 million, despite a 56% increase in operating expenses. Net income was $17.391 million versus $5.711 million; diluted earnings per share rose to $0.32 from $0.10. Free cash flow was $8.6 million.
BillionToOne expects profitability similar to current levels despite continued investment. Its Northstar Clear blood-based residual cancer detection test is scheduled for commercial availability on December 15, 2026.
BillionToOne (NASDAQ: BLLN) will participate in two upcoming investor conferences, with fireside chats scheduled for November 10 and 11, 2026.
The UBS Global Healthcare Conference chat is November 10 at 2:00 PM ET; the Stifel 2026 Healthcare Conference chat is November 11 at 3:20 PM ET. Live and archived webcasts will be available on the Events page of the company's investor relations website.
BillionToOne (BLLN) plans to release its third-quarter 2026 financial results after market close on November 4, 2026.
The quarter ended September 30, 2026. A conference call to discuss the results will begin that day at 1:30pm Pacific Time / 4:30pm Eastern Time. A live and archived webcast will be available on the Events page of the company’s investor relations website.
BillionToOne (BLLN) announced a peer-reviewed study comparing its Northstar Response blood test with a tumor-informed assay for advanced cancer treatment monitoring. Published in The Journal of Liquid Biopsy, the retrospective study evaluated 169 paired samples from 61 patients. A subset included 71 samples from 36 patients with sequential concurrent blood draws collected within seven days of each other.
The assays agreed on the direction of tumor burden change in 94% of evaluable sequential pairs (67 of 71). In all divergent cases, Northstar Response matched findings supported by imaging and/or biopsy. Quantitative results across repeated measurements were closely aligned after patient-specific baseline normalization, with conditional R² of 0.97. Northstar Response measures circulating tumor DNA—DNA shed by tumors into blood—without requiring tissue sequencing.
BillionToOne (BLLN) announced that its management will participate in the Wells Fargo 21st Annual Healthcare Conference. The team is scheduled for a fireside chat from 2:15pm to 2:50pm Eastern Time on Wednesday, September 9, 2026. A live and archived webcast will be accessible via the Events & Presentations section of the company’s investor relations website.
BillionToOne (Nasdaq: BLLN) launched Northstar Origin, a physician-ordered liquid biopsy add-on test that predicts tissue of origin from circulating cell-free DNA for patients with cancer of unknown primary or uncertain diagnoses, using the same blood draw as the Northstar Select assay.
The company reports that Northstar Origin, combining methylation profiling with tissue-specific somatic variants, correctly identified the primary site as its top prediction in 87% of 1,578 validation cases and within the top three in 91%. BillionToOne also expanded its Northstar Select comprehensive genomic profiling panel from 84 to 102 genes, adding 18 genes including MTAP deletion while maintaining stated sensitivity.
BillionToOne (Nasdaq: BLLN) reported publication in The Green Journal of a large prospective, multi-site study evaluating its Unity Fetal Risk Screen cfDNA test for recessive conditions in a general-risk pregnancy population. The study followed 2,212 pregnant carriers at nine U.S. institutions where partner carrier status was unknown, mirroring routine prenatal practice.
According to BillionToOne, pregnancy outcomes were collected for 98.6% of eligible cfDNA results. Unity Fetal Risk Screen showed 94.4% sensitivity, 99.5% specificity, and >99.9% negative predictive value for cystic fibrosis, spinal muscular atrophy, and alpha- and beta-hemoglobinopathies, and delivered personalized fetal risk estimates ranging from as high as 9-in-10 to as low as 1-in-10,000. The company said performance was consistent across a racially and ethnically diverse population and that the data strengthen the evidence for using cfDNA fetal risk assessment as a primary screen within its Unity Complete prenatal portfolio.
BillionToOne (Nasdaq: BLLN) reported publication in The Green Journal of a prospective, multi-site study evaluating its Unity Fetal Risk Screen cfDNA test for recessive conditions in a large, general-risk pregnancy population.
The nine-center U.S. study followed 2,212 pregnant carriers whose partners’ carrier status was unknown, with outcomes collected for 98.6% of pregnancies completing care. Unity Fetal Risk Screen assessed fetal risk for cystic fibrosis, spinal muscular atrophy, and alpha- and beta-hemoglobinopathies, demonstrating 94.4% sensitivity, 99.5% specificity, and >99.9% negative predictive value. According to BillionToOne, traditional carrier screening classifies fewer than 50% of affected pregnancies as high risk, largely due to incomplete partner testing, while Unity directly estimates fetal risk, providing personalized probabilities from as high as 9-in-10 to as low as 1 in 10,000. Performance was consistent across racially and ethnically diverse groups, and the test is part of the Unity Complete prenatal portfolio, which the company is expanding with a new 130-gene fetal risk panel.
BillionToOne (NASDAQ: BLLN) reported second quarter 2026 revenue of $109.4 million, up 64% year-over-year, driven by a 35% increase in total tests delivered to 196,000 and a 21% rise in overall ASP to $551. Prenatal revenue reached $94.2 million (+55%), oncology revenue $13.7 million (+176%), and gross margin expanded to 70% from 65%.
Income from operations was $5.5 million versus a $1.6 million loss a year ago, with net income of $8.1 million ($0.15 diluted EPS). Free cash flow was $5.1 million. BillionToOne reiterated 2026 revenue guidance of $450–$465 million (48–52% growth) and expects profitability similar to current levels. The company highlighted upcoming launches of an expanded 130-gene Unity Fetal Risk Screen on August 17, 2026 and Northstar Origin on September 1, 2026, and reported strong immunotherapy survival prediction data for Northstar Response.
BillionToOne (Nasdaq: BLLN) has appointed renowned oncology physician-scientist Ethan Dmitrovsky, MD as Chief Medical Officer, Oncology, effective July 20, 2026. He will lead medical strategy for the Northstar liquid biopsy portfolio, focusing on expanding clinical adoption in solid-tumor treatment decisions and driving the company’s entry into minimal residual disease (MRD) testing.
According to BillionToOne, Dmitrovsky brings leadership experience from Frederick National Laboratory, MD Anderson Cancer Center, and Dartmouth, along with a track record of translating cancer research into FDA-approved therapies. The Northstar portfolio includes Northstar Select and Northstar Response plus recent launches Northstar PGx and Northstar Select CH.