BillionToOne, Inc.

BillionToOne’s Tissue-Free Northstar Response® Demonstrates On-Par to Superior Cancer Treatment Monitoring vs. Tumor-Informed Assay, New Peer-Reviewed Study Finds

BillionToOne announced publication in The Journal of Liquid Biopsy of the first peer-reviewed head-to-head study comparing its tissue-free Northstar Response assay against a commercially available tumor-informed ctDNA assay for treatment monitoring in advanced cancer. Across 169 paired samples from 61 patients, quantitative results were closely aligned (conditional R² = 0.97) and the two assays agreed on tumor burden direction in 94% of sequential pairs; in all divergent cases Northstar Response matched imaging/biopsy ground truth. The data support a tumor-agnostic, tissue-free commercial positioning for Northstar Response, though the test remains an FDA-unapproved laboratory-developed test and the study is retrospective.

•25d ago

BillionToOne Launches Northstar Origin, a New Liquid Biopsy Test to Help Identify Tissue of Origin

BillionToOne launched Northstar Origin, a new liquid biopsy add-on test designed to predict tissue of origin for cancers of unknown primary using a single blood draw, reducing the need for additional tissue samples. Validation data from a cohort of 1,578 patients demonstrated that Northstar Origin correctly identified the tissue of origin as its top prediction in 87% of cases and within the top three predictions in 91% of cases. The company also expanded its Northstar Select panel from 84 to 102 genes, adding new biomarkers such as MTAP deletion while maintaining sensitivity, with studies showing it detected 51% more SNV/Indels than competitors.

•2mo ago

/C O R R E C T I O N -- BillionToOne/

BillionToOne announced the publication of a prospective study in Obstetrics & Gynecology involving 2,212 general-risk pregnancies, which demonstrated that its Unity Fetal Risk Screen achieved 94.4% sensitivity and 99.5% specificity. The study is the first of its kind conducted in an intended-use screening population, showing that cfDNA fetal risk assessment identifies more affected pregnancies than traditional carrier screening, which often misses cases due to incomplete partner testing. Separately, the company noted it is expanding its fetal risk screen portfolio to include a new 130-gene panel, advancing its comprehensive prenatal screening capabilities.

•2mo ago

BillionToOne Reports Second Quarter 2026 Results and Reiterates 2026 Revenue Guidance

BillionToOne delivered Q2 2026 revenue of $109.4 million, representing 64% year-over-year growth, while swinging to an operating profit of $5.5 million compared to a prior-year loss. The oncology segment drove substantial upside with revenue surging 176% to $13.7 million, complemented by a 55% increase in prenatal revenue to $94.2 million and a gross margin expansion to 70%. Management reiterated full-year 2026 revenue guidance of $450 million to $465 million, targeting 48% to 52% growth, and announced upcoming product launches including an expanded Unity Fetal Risk Screen.

•2mo ago

BillionToOne Appoints Ethan Dmitrovsky, MD, as Chief Medical Officer, Oncology, to Lead Medical Strategy for Northstar

BillionToOne appointed Dr. Ethan Dmitrovsky, a renowned oncology leader and former director of the Frederick National Laboratory, as Chief Medical Officer, Oncology. Dr. Dmitrovsky will lead medical strategy for the Northstar liquid biopsy portfolio, overseeing its expansion into minimal residual disease (MRD) testing and broader clinical adoption. The company noted that Northstar Select has been shown to uncover 50% more clinically actionable alterations than competitors, while Northstar Response offers single-molecule precision for monitoring.

•3mo ago

BillionToOne's Northstar Response® Is a Stronger Predictor of Immunotherapy Outcomes Than Standard-of-Care Imaging for Cancer Patients in Peer-Reviewed Study

BillionToOne announced the publication of a peer-reviewed study in The Journal of Liquid Biopsy demonstrating that its Northstar Response assay is a stronger predictor of survival than standard-of-care imaging for immunotherapy patients. Data from 142 patients across 12 solid tumor types showed molecular progression was the dominant independent predictor of survival with a hazard ratio of 5.3, detecting progression a median of 62 days before imaging. While the study highlights the assay's ability to resolve clinical dilemmas and provide an earlier actionable window, the company noted that Northstar Response is a laboratory-developed test not yet cleared or approved by the FDA.

•4mo ago

BillionToOne Reports First Quarter 2026 Results and Raises 2026 Revenue Guidance

BillionToOne reported Q1 2026 revenue of $108.4 million, up 84% year-over-year, driven by a 44% increase in test volume and a 28% increase in average selling price. The company raised full-year 2026 revenue guidance to $450 million to $465 million, representing 48% to 52% growth over 2025, up from prior guidance of $430 million to $445 million. Profitability improved significantly, with Q1 operating income of $17.8 million compared to a loss of $2.3 million in the prior year, while free cash flow reached $11.0 million.

•5mo ago