BillionToOne Unveils Northstar Select® with Exceptional Sensitivity in Oncology Testing

BillionToOne's Northstar Select®: A Breakthrough in Cancer Diagnostics

In a significant development for cancer diagnostics, BillionToOne, Inc. has announced the publication of a validation study for its innovative Northstar Select®, a liquid biopsy assay that demonstrates unprecedented sensitivity in detecting genetic alterations in advanced solid tumor cancers. Conducted across multiple oncology clinics and hospitals, the study compared the performance of Northstar Select against six other liquid biopsy assays, revealing its capacity to uncover 51% more pathogenic single nucleotide variants (SNVs) and 109% more copy number variants (CNVs) than its competitors.

Study Overview

This prospective study controlled for variability by involving 182 patients with over 17 different types of solid tumors. Researchers examined the efficacy of different liquid biopsy assays, all of which were sourced from reputable CLIA/CAP laboratories. The focus was on how well these assays could detect clinically actionable alterations in circulating tumor DNA (ctDNA). The results showed that Northstar Select significantly outperformed the other assays, not only in raw detection numbers but also in specificity, achieving over 99.9% accuracy.

One of the standout features of Northstar Select is its ability to accurately identify alterations in challenging cases, particularly in patients with central nervous system cancers. While conventional assays typically report detection rates between 27-55%, Northstar Select achieved an impressive 87% detection rate in these difficult cases, further highlighting its clinical relevance.

Enhanced Sensitivity in Detection

What sets Northstar Select apart is its unique sensitivity, particularly important for identifying actionable treatment options for patients whose tumors do not shed substantial amounts of DNA into the bloodstream. Notably, 91% of additional clinically actionable variants detected were identified below 0.5% variant allele frequency (VAF), where other tests have traditionally struggled. This advancement provides essential insights for treatment decisions in patients who would otherwise be left without clear pathways for personalized care.

The assay is designed to cover a broad range of variables including SNVs, CNVs, gene fusions, and microsatellite instability high detection (MSI-H), maintaining a scalable approach that enhances its ability to adapt as new discoveries in oncology are made. Its ability to distinguish between clinically actionable focal copy number changes and broad chromosomal aneuploidies is particularly meaningful, adding a layer of precision that is often missing in other assays.

Medicare Coverage and Clinical Implications

Following its successful validation, Northstar Select has begun to meet Medicare coverage criteria, as confirmed by Palmetto GBA, a primary contractor responsible for managing the Molecular Diagnostics Services program. This coverage will significantly expand access to this advanced diagnostic tool, allowing more patients to benefit from its enhanced capability and ultimately leading to better treatment outcomes.

Dr. Gary Palmer, Chief Medical Officer of BillionToOne, emphasized the implications of this groundbreaking assay, stating, "Current liquid biopsy assays often fall short in detecting clinically relevant alterations. Northstar Select’s superior sensitivity means we can identify more actionable treatment options for significantly more patients, especially those with challenging tumor types."

Conclusion

With the launch of Northstar Select, BillionToOne sets a new benchmark in the field of molecular diagnostics, providing powerful, efficient, and accessible solutions to the pressing challenges faced in cancer treatment today. Their commitment to innovation and patient care is reflected not only in the robust performance of Northstar Select but also in their broader mission to revolutionize the landscape of cancer diagnostics altogether. To learn more about Northstar Select and its capabilities, visit northstaronc.com.