BillionToOne’s Tissue-Free Northstar Response® Demonstrates On-Par to Superior Cancer Treatment Monitoring vs. Tumor-Informed Assay, New Peer-Reviewed Study Finds
Key Highlights
- ➤Northstar Response matched tumor-informed assay conclusions in 94% of sequential pairs
- ➤Study evaluated 169 paired samples from 61 advanced cancer patients
- ➤Northstar Response aligned with imaging or biopsy in all divergent cases
- ➤Patient-normalized repeated measurements closely aligned, with conditional R² of 0.97
- ➤Northstar Response requires no tumor tissue, potentially accelerating monitoring by weeks
Expert Statements
Vaia Florou, MD, MS, Associate Professor, Division of Oncology, Huntsman Cancer Institute at the University of Utah
“The ability to combine cancer-associated methylation with single-molecule precision to track changing tumor signal directly from blood is game-changing, as so many patients in the clinic will benefit”
Vaia Florou, MD, MS, Associate Professor, Division of Oncology, Huntsman Cancer Institute at the University of Utah
“These results showing that a standardized assay can deliver precise longitudinal monitoring without tissue dependency are incredibly relevant for those of us practicing on the frontlines of cancer care.”
Allen Chen, MD, Vice President of Oncology Clinical Development and Medical Affairs at BillionToOne
“Not only does Northstar Response deliver highly accurate insight into how disease is evolving during treatment, but it also has the added advantage of a streamlined and efficient workflow that can bring molecular testing to more patients”
Allen Chen, MD, Vice President of Oncology Clinical Development and Medical Affairs at BillionToOne
“Treatment monitoring must be both reliable and practical for it to be effective in routine oncology care. These results show that clinicians do not need to compromise one for the other.”
MENLO PARK, Calif., Oct. 07, 2026 (GLOBE NEWSWIRE) -- BillionToOne, Inc. (Nasdaq: BLLN), a next-generation molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, announced the publication of the first peer-reviewed head-to-head study comparing Northstar Response®, a tissue-free, methylation-based liquid biopsy assay utilizing patented single-molecule counting technology to measure the absolute number of circulating tumor DNA (ctDNA) molecules, with a commercially available tumor-informed ctDNA assay for advanced cancer patients undergoing treatment. The study found that Northstar Response tracked disease dynamics on par with or better than the tumor-informed comparator, without requiring tissue sequencing.
The retrospective real-world study, published in The Journal of Liquid Biopsy, evaluated 169 paired samples from 61 patients, with 71 samples from 36 patients that had sequential concurrent draws for the two assays collected within seven days of each other. Quantitative results, after patient-specific baseline normalization, across repeated measurements were shown to be closely aligned (conditional R² = 0.97). Across evaluable sequential pairs, the two approaches reached the same conclusion of the change in tumor burden direction in 94% of cases (67 of 71).
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