MENLO PARK, Calif., June 29, 2026
BillionToOne has announced the publication of a peer-reviewed clinical study demonstrating that its Northstar Response® liquid biopsy assay is a stronger predictor of immunotherapy outcomes than standard-of-care imaging for patients with advanced solid tumors. Published in The Journal of Liquid Biopsy, the study highlights the growing role of circulating tumor DNA (ctDNA)-based molecular monitoring in precision oncology by showing that Northstar Response® identified disease progression significantly earlier than conventional radiographic imaging while providing superior prognostic information for patient survival. Conducted in collaboration with the Allegheny Health Network Cancer Institute, the prospective study evaluated 142 patients across 12 different solid tumor types, demonstrating that integrating serial blood-based molecular monitoring with imaging substantially improves clinicians’ ability to assess treatment response. The findings reinforce the potential of advanced liquid biopsy technologies to support earlier therapeutic decision-making, optimize immunotherapy management, and advance personalized cancer care by providing oncologists with clinically actionable information before traditional imaging detects disease progression.
Peer-Reviewed Study Validates Superior Predictive Performance
The prospective study enrolled 142 patients receiving immunotherapy or immunotherapy combination therapy across two independent clinical cohorts representing 12 different solid tumor types. Researchers compared the performance of Northstar Response®, a tissue-free methylation-based ctDNA monitoring assay, against conventional RECIST-based radiographic imaging using blinded central review. Results demonstrated that molecular progression measured by Northstar Response® emerged as the strongest independent predictor of patient survival, with a hazard ratio of 5.3, substantially outperforming standard imaging alone.
Even greater predictive accuracy was achieved when molecular monitoring was combined with imaging, where patients demonstrating progression by both methods experienced the poorest clinical outcomes, producing a hazard ratio of 13.8 during landmark assessment and 19.7 with continued longitudinal monitoring. The study also showed that Northstar Response® detected cancer progression a median of 62 days earlier than conventional clinicoradiographic assessment, providing physicians with a valuable opportunity to reassess treatment strategies before disease progression becomes clinically apparent.
Serial ctDNA Monitoring Strengthens Precision Oncology
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One of the study’s most clinically important findings involved patients classified as having stable disease by conventional imaging. While radiographic scans often struggle to distinguish between temporary treatment effects and true disease progression, Northstar Response® successfully identified patients at significantly higher risk through serial ctDNA monitoring, offering valuable prognostic information that imaging alone could not provide. Investigators also identified a molecular rebound pattern in approximately 25% of patients, where an initial favorable ctDNA response was followed by rising molecular signals indicating likely treatment failure.
These findings demonstrate the importance of serial blood sampling rather than relying on single-point molecular assessments, particularly for patients receiving immunotherapy. Powered by BillionToOne’s proprietary single-molecule next-generation sequencing (smNGS) platform and Quantitative Counting Template™ (QCT™) technology, Northstar Response® enables accurate quantification of tumor-specific methylation from routine blood draws without requiring tumor tissue, making longitudinal treatment monitoring more accessible and less invasive for patients.
Liquid Biopsy Innovation Expands Personalized Cancer Care
The publication further strengthens BillionToOne’s precision oncology portfolio, where Northstar Response® complements the company’s Northstar Select® comprehensive genomic profiling assay by supporting clinicians throughout the entire cancer treatment journey—from therapy selection to ongoing treatment monitoring. As immunotherapy continues transforming cancer care, reliable methods capable of detecting treatment response earlier than conventional imaging are becoming increasingly important for improving patient outcomes and optimizing therapeutic decisions.
The peer-reviewed evidence demonstrates that integrating advanced liquid biopsy technologies with standard imaging significantly enhances clinical decision-making, enabling earlier intervention and more personalized treatment strategies. By combining innovative molecular diagnostics with artificial intelligence-driven genomic analysis, BillionToOne continues advancing the future of precision oncology while helping physicians deliver more individualized and effective cancer care across multiple solid tumor types.
Source: BillionToOne press release
