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BillionToOne Publishes Northstar Response Liquid Biopsy Study

BillionToOne 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 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. Across evaluable sequential pairs, the two approaches reached the same conclusion of the change in tumor burden direction in 94% of cases. Importantly, in all of the divergent cases, Northstar Response results were concordant with the ground truth substantiated by imaging and/or biopsy, indicating that the tumor-informed results were either false-positives or false-negatives. For instance, Northstar Response detected progression in cases where the tumor had evolved since the original biopsy, including a case of hormone receptor conversion in advanced breast cancer. Together, the cases illustrate the particular value of tumor-agnostic monitoring to track tumor burden and evolution.

BillionToOne Launches Northstar Origin Liquid Biopsy Add-On Test

BillionToOne announced the launch of Northstar Origin, a new liquid biopsy add-on test for tissue-of-origin prediction, along with the expansion of its Northstar Select panel from 84 to 102 genes to cover genes that are included in recent and upcoming FDA approvals. "Community oncologists are often asked to make the same complex diagnostic decisions as physicians at academic centers, without the same access to tumor boards or subspecialty pathology support," said Ethan Dmitrovsky, MD, Chief Medical Officer, Oncology at BillionToOne. "Northstar Origin is designed to help close that gap. It is a highly accurate, easy-to-use diagnostic aid that can be added to the liquid biopsy a patient already receives for therapy selection. Northstar Origin can extend more equitable access to care."

BillionToOne Launches Northstar Origin Liquid Biopsy Test

BillionToOne announced the launch of Northstar Origin, a new liquid biopsy add-on test for tissue-of-origin prediction, along with the expansion of its Northstar Select panel from 84 to 102 genes to cover genes that are included in recent and upcoming FDA approvals. "Community oncologists are often asked to make the same complex diagnostic decisions as physicians at academic centers, without the same access to tumor boards or subspecialty pathology support," said Ethan Dmitrovsky, MD, Chief Medical Officer, Oncology at BillionToOne. "Northstar Origin is designed to help close that gap. It is a highly accurate, easy-to-use diagnostic aid that can be added to the liquid biopsy a patient already receives for therapy selection. Northstar Origin can extend more equitable access to care."