Northstar PGx and Northstar Select CH provide pharmacogenomic insights and clonal hematopoiesis detection from the same blood draw as existing tumor profiling test.
BillionToOne has launched two add-on applications for its Northstar Select liquid biopsy platform designed to help oncologists make more informed treatment decisions for patients with advanced solid tumors.
The Menlo Park, California-based molecular diagnostics company announced the availability of Northstar PGx and Northstar Select CH, which extend the clinical utility of its existing Northstar Select test while maintaining the same 5-day average turnaround time.
Northstar PGx provides pharmacogenomic analysis of key variants in DPYD and UGT1A1 genes, which are recognized in oncology guidelines and FDA labeling for their impact on fluoropyrimidine and irinotecan-based therapies. The test reports a patient’s predicted metabolizer status and associated clinical implications to help inform treatment planning.
The launch addresses recent guideline changes that emphasize broader testing to avoid potential chemotherapy toxicity, including DPD deficiency testing prior to prescribing capecitabine or fluorouracil.
Addressing False Positives in Liquid Biopsy Testing
Northstar Select CH targets clonal hematopoiesis, a condition that can cause false positives in circulating tumor DNA testing. Research indicates that approximately 25% of patients have at least one clinically actionable mutation detected by liquid biopsy that originates from white blood cells rather than tumor tissue, potentially leading to inappropriate treatment decisions.
The test combines targeted white blood cell genomic DNA sequencing for all guideline-recommended genes with machine-learning classification for other genes. BillionToOne reports the approach achieves greater than 99% accuracy in distinguishing tumor-derived alterations from non-tumor findings.
“These launches reflect our continued commitment to answering the most critical question oncologists face: which treatment fits the best for my patient,” says Gary Palmer, MD, JD, chief medical officer of oncology at BillionToOne, in a release. “The launch of pharmacogenomics and clonal hematopoiesis applications further empowers oncologists to choose the right therapy for the patients by avoiding potentially ineffective therapies.”
Platform Performance Data
The Northstar Select platform demonstrated superior performance in a prospective head-to-head comparison study that included 182 patients with more than 17 solid tumor types. The test detected 51% more clinically actionable single nucleotide variants and insertions/deletions and 109% more copy number variants than available comparators, with 45% fewer null reports.
The superior sensitivity was validated through orthogonal testing with digital droplet PCR, demonstrating 98% concordance with Northstar Select results.
Both add-on tests are ordered at the time of Northstar Select testing and integrated into the platform’s reporting system. BillionToOne’s Quantitative Counting Templates molecular counting platform uses multiplex technology to count DNA molecules at the single-molecule level.
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