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

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Tissue-free ctDNA monitoring was the dominant independent predictor of survival across 12 tumor types and two prospective cohorts MENLO PARK, Calif., June 29, 2026 /PRNewswire/ -- BillionToOne, Inc. (Nasdaq: BLLN), a next-generation molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, today announced the publication of Longitudinal Methylated ctDNA Increases Predict Immunotherapy Progression Across Solid Tumors, a peer-reviewed study demonstrating that Northstar Response® was a stronger predictor of survival than standard-of-care imaging in patients with advanced solid tumors receiving immunotherapy or immunotherapy combination therapy, and that the addition of molecular monitoring to imaging provided greater predictive power than imaging alone. The findings were reproduced in an independent prospective validation cohort, with consistent results across tumor types and treatment regimens. Conducted in collaboration with the Allegheny Health Network Cancer Institute, the study enrolled 142 patients across two independent cohorts spanning 12 solid tumor types. In a multivariate analysis incorporating both Northstar Response and blinded central radiographic review using RECIST criteria, molecular progression emerged as the dominant independent predictor of survival (hazard ratio 5.3), substantially outweighing radiographic progression. The strongest predictive performance came from pairing Northstar Response with imaging: patients whose disease progressed on both molecular and imaging assessment had the poorest outcomes of all (hazard ratio 13.8 at the landmark assessment; 19.7 with continued longitudinal monitoring), and the combined molecular-plus-imaging approach achieved the highest predictive discrimination of any method evaluated. Northstar Response also helped resolve a particularly challenging clinical dilemma in oncology: patients whose imaging show "stable disease" and thus have findings that cannot reliably be distinguished between early treatment benefit and failure. Among these patients, molecular progression identified those at substantially higher risk and conveyed prognostic information that imaging alone could not provide. On average, Northstar Response identified cancer progression a median of 62 days before clinicoradiographic progression, representing a potentially actionable window...

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