BillionToOne's Northstar Select Liquid Biopsy Selected for Major Japanese Lung Cancer Resistance Study
核心洞察
BillionToOne (搜索)'s Northstar Select (搜索) liquid biopsy has been selected for the LC-SCRUM-TRY study at Japan's National Cancer Center Hospital East, focusing on treatment-resistant non-small cell lung cancer.
The ultra-sensitive test demonstrated superior performance in head-to-head comparisons, detecting genetic variants at frequencies as low as 0.15% using proprietary single-molecule NGS technology.
The selection addresses critical barriers in obtaining tissue biopsies from drug-resistant tumors, offering a non-invasive alternative for comprehensive genomic profiling.
BillionToOne (搜索) announced that its Northstar Select (搜索) liquid biopsy has been selected as the new genomic profiling platform for the LC-SCRUM-TRY study, a nationwide multi-center clinical investigation led by Japan's National Cancer Center Hospital East (NCCHE). The study focuses on elucidating mechanisms of drug resistance in non-small cell lung cancer (NSCLC) patients.
Ultra-Sensitive Technology Addresses Clinical Barriers
The LC-SCRUM-TRY study, launched in 2020 with over 100 participating institutions, has analyzed approximately 2,000 clinical specimens from patients with advanced or recurrent NSCLC following drug resistance. Previously, genomic analysis relied primarily on tissue biopsies from drug-resistant tumors, but obtaining these samples presents significant challenges including difficult-to-biopsy tumor locations, insufficient tumor samples, and patient reluctance to undergo invasive procedures.
To overcome these barriers, investigators adopted plasma-based liquid biopsy using cell-free DNA (cfDNA (搜索)) genomic analysis as a non-invasive alternative. However, sensitivity remained a critical performance requirement for detecting targetable alterations that may be rare or difficult to uncover in blood samples.
Superior Performance in Head-to-Head Validation
Prior to selecting Northstar Select (搜索), the research team evaluated the accuracy of previously used liquid biopsy assays by comparing paired tumor tissue and plasma samples from approximately 1,000 patients with untreated advanced or recurrent NSCLC in the LC-SCRUM-Asia genetic screening study. According to trial investigators, broader clinical adoption of liquid biopsies required significantly higher sensitivity.
Northstar Select (搜索)'s single-molecule NGS (smNGS) platform, powered by proprietary Quantitative Counting Templates (QCT) technology, delivers ultrasensitive and precise quantification of DNA molecules. Recent peer-reviewed, prospective head-to-head data published in The Journal of Liquid Biopsy demonstrated that Northstar Select outperformed other commercially available liquid biopsy tests, achieving the highest sensitivity for therapy selection and reliably detecting SNVs (搜索) and indels (搜索) at variant allele frequencies as low as 0.15% (95% LoD).
Clinical Implementation and Medicare Coverage
Based on these validation results and a successful feasibility pilot, Northstar Select (搜索) was chosen as the preferred liquid biopsy platform for comprehensive genomic analysis in the LC-SCRUM-TRY study, beginning November 2025. The test has met Medicare coverage criteria established by Palmetto GBA, a Medicare administrative contractor that administers the Molecular Diagnostics Services program (MolDx), following rigorous review of evidence demonstrating analytical validity, clinical validity, and clinical utility.
"Expanding access to cutting-edge precision medicine tools is a critical need for lung cancer patients in Japan, and we are excited to launch the next phase of LC-SCRUM-TRY through our collaboration with BillionToOne (搜索)," said Koichi Goto, MD, PhD, Deputy Director of NCCHE. "By integrating the highly sensitive Northstar Select (搜索) liquid biopsy into the study, we expect to find more opportunities to better characterize drug-resistant cancers—an important step toward identifying more effective therapies for patients with treatment-resistant disease."
Strategic Significance for Precision Medicine
Northstar Select (搜索) is a comprehensive genomic profiling liquid biopsy that enables oncologists to select optimal treatments for advanced cancer patients without requiring invasive tissue biopsies. The platform's proprietary QCT molecular counting technology represents the only multiplex technology capable of accurately counting DNA molecules at the single-molecule level.
"Being selected as the liquid biopsy platform for LC-SCRUM-TRY is a significant validation of Northstar Select (搜索)'s proven sensitivity," said BillionToOne (搜索) Chief Product Officer Shan Riku. "We're honored to partner with NCCHE on this important initiative to advance treatment options for patients with drug-resistant lung cancer."
The collaboration represents a significant advancement in precision medicine accessibility for Japanese lung cancer patients, particularly those with treatment-resistant disease where traditional tissue-based genomic analysis faces substantial practical limitations.