BillionToOne has launched Northstar Origin, a liquid biopsy add-on that predicts cancer tissue of origin from cell-free DNA, and expands its genomic profiling panel to 102 genes.
BillionToOne announced the launch of Northstar Origin, a liquid biopsy add-on test designed to predict tissue of origin directly from circulating cell-free DNA (cfDNA). The company also expanded its Northstar Select genomic profiling panel from 84 to 102 genes.
Northstar Origin is a physician-ordered add-on test to Northstar Select intended for patients with cancer of unknown primary (CUP) or uncertain cancer diagnoses. According to a company release, the assay reduces the need for additional tissue biopsies or separate blood draws by evaluating the same blood sample already collected for therapy selection.
The assay combines methylation profiling with single-molecule precision and integrates an independent signal obtained from tissue-specific somatic variants detected by Northstar Select.
Roughly 3% to 5% of new cancer diagnoses present as CUP, in which standard pathology and imaging cannot confidently identify a primary tumor source, according to study data cited in the company release. Additionally, up to 10% of patients in community oncology settings without access to detailed pathology workups may receive uncertain diagnoses.
“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,” says Ethan Dmitrovsky, MD, chief medical officer, oncology at BillionToOne, in a release. “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.”
Validation and Diagnostic Performance
The performance of the classifier was developed using 6,025 blood samples from patients with advanced cancer and subsequently evaluated in an independent validation cohort of 1,578 patients, according to BillionToOne.
In the validation study, the model identified the correct tissue of origin as its top prediction in 87% of cases and ranked it within its top three predictions in 91% of cases. The company plans to conduct prospective studies to evaluate clinical utility and expand the model to additional tumor types.
“Cancers of unknown primary have historically posed a challenge because not knowing where the tumor originated leads to treatment uncertainty and patient anxiety,” says Allen Chen, MD, vice president of oncology clinical development and medical affairs at BillionToOne, in a release. “In these scenarios, conventional workup, including physical examination, imaging, and pathology, is unfortunately often not enough. Northstar Origin provides clinicians with an additional, complementary molecular prediction from the same blood sample used for therapy selection. Studies have consistently shown that uncovering the primary site results in more personalized therapy and better outcomes.”
Expanded Panel and Regulatory Status
Alongside the launch of Northstar Origin, BillionToOne expanded its Northstar Select genomic profiling assay for advanced solid tumors from 84 to 102 genes to cover biomarkers associated with recent and upcoming approvals from the Food and Drug Administration (FDA).
The update adds 18 new genes to the panel, including MTAP deletion, an emerging biomarker involving copy number loss that has historically presented technical detection challenges for liquid biopsy assays, according to the company.
Northstar Origin and Northstar Select are laboratory-developed tests performed in a Clinical Laboratory Improvement Amendments-certified and College of American Pathologists-accredited laboratory, according to the company release. The tests are intended to complement, rather than replace, standard pathologic determination and clinical evaluation, and have not been cleared or approved by the FDA.
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