Announcement • Jun 30

BillionToOne, Inc. Announces Publication of Longitudinal Methylated Ctdna Increases Predict Immunotherapy Progression Across Solid Tumors

BillionToOne 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 for oncologists to reassess surveillance or treatment strategy before conventional methods signal failure. The assay achieves this through simple serial blood draws collected throughout treatment that integrate into routine oncology practice. The study also found that 1 in 4 patients exhibited a molecular rebound pattern (an early favorable decrease signal followed by a subsequent rise) that suggests a single ctDNA assessment could misclassify patients as responding when the likelihood of treatment failure remains high. Only through serial sampling across multiple cycles were the investigators able to fully capture this kinetic shift, underscoring an important limitation of single-timepoint monitoring approaches for patients receiving immunotherapy. The Northstar Response assay uses proprietary single-molecule next-generation sequencing (smNGS) platform with Quantitative Counting Template (QCT) technology to quantify tumor-specific methylation from a simple blood draw, enabling treatment response monitoring across multiple solid tumor types. Northstar Response complements Northstar Select, BillionToOne's liquid biopsy for therapy selection in cancer patients. Together, the assays support clinicians from treatment selection through ongoing response monitoring without dependence on tumor tissue. Northstar Select, BillionToOne's highly sensitive comprehensive genomic profiling (CGP) liquid biopsy assay, demonstrated superior performance in detecting more clinically actionable alterations in circulating tumor DNA (ctDNA) compared to other liquid biopsy tests on the market. In a prospective head-to-head comparison study which included 182 patients with more than 17 solid tumor types, Northstar Select detected 51% more clinically actionable or pathogenic single nucleotide variant (SNV)/Indels and 109% more copy number variants (CNVs) than the aggregated results from available comparators, with 45% fewer null reports. Northstar Response is BillionToOne's tissue-free, methylation-based ctDNA assay purpose-built for treatment response monitoring in patients with cancer. Powered by the company's patented QCT molecular counting platform — the only multiplex technology capable of counting DNA molecules at the single-molecule level — Northstar Response quantifies tumor burden through serial blood draws with no dependence on tumor tissue at any stage of the patient journey. Northstar Select and Northstar Response may produce false-positive or false-negative results. Test results are not a guarantee of the presence or absence of disease or treatment response and should not be used as the sole basis for medical decision-making. Results should be interpreted in conjunction with the patient's clinical presentation, radiographic findings, and other diagnostic information. Northstar Response is intended to complement, not replace, standard clinical and radiographic assessment of disease status. Northstar Select and Northstar Response are laboratory-developed tests (LDTs) performed in a CLIA-certified and CAP-accredited laboratory. These tests have not been cleared or approved by the U.S. Food and Drug Administration (FDA). Test performance may vary based on factors including cancer type, disease burden, treatment, and specimen characteristics.

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