BillionToOne Announces Selection of Northstar Select® for LC-SCRUM-TRY Clinical Study
BillionToOne, Inc. (Nasdaq: BLLN), a leading molecular diagnostics company, has been selected to provide its cutting-edge liquid biopsy test, Northstar Select®, in the pivotal LC-SCRUM-TRY clinical study. This initiative, launched by the National Cancer Center Hospital East (NCCHE) in Kashiwa, Japan, aims to explore drug resistance mechanisms in patients with advanced non-small cell lung cancer (NSCLC) beginning November 2025.
Key Features of the LC-SCRUM-TRY Study
The LC-SCRUM-TRY study represents a nationwide effort involving over 100 institutions to conduct comprehensive genomic analyses of approximately 2,000 clinical specimens from patients facing drug-resistant NSCLC. Traditional tissue biopsies often present challenges, such as:
- Difficulty accessing tumor locations for biopsy
- Insufficient tumor samples for analysis
- Patient unease with invasive procedures
To address these obstacles, the study will utilize non-invasive plasma-based liquid biopsy techniques that analyze cell-free DNA (cfDNA).
Importance of Sensitivity in Liquid Biopsies
Sensitivity is a critical factor in effectively diagnosing and treating NSCLC. The LC-SCRUM-TRY team previously assessed the performance of existing liquid biopsy tests by analyzing paired tumor tissue and plasma samples from approximately 1,000 patients. These results underscored the urgent need for liquid biopsies with enhanced sensitivity.
The Northstar Select platform employs single-molecule next-generation sequencing (smNGS) technology, which, through proprietary Quantitative Counting Templates™ (QCT™), allows for ultra-sensitive identification of DNA changes. Recent studies published in The Journal of Liquid Biopsy indicate that Northstar Select outshines competing liquid biopsy tests by achieving sensitivity levels able to detect variant allele frequencies as low as 0.15% (95% limit of detection).
Collaboration with NCCHE
Koichi Goto, MD, PhD, Deputy Director of NCCHE, stated, "Expanding access to cutting-edge precision medicine tools is a critical need for lung cancer patients in Japan. Our collaboration with BillionToOne will allow us to characterize drug-resistant cancers more effectively and identify improved treatment options."
Northstar Select facilitates oncologists in selecting appropriate therapies for advanced cancer patients without resorting to invasive tissue biopsies. Its success in clinical validations meets Medicare coverage criteria, bolstering access to personalized treatment strategies for patients.
BillionToOne's Future Prospects
Shan Riku, Chief Product Officer at BillionToOne, remarked, "Being selected as the liquid biopsy platform for LC-SCRUM-TRY is a significant validation of Northstar Select's proven sensitivity." As the company moves forward in partnership with NCCHE, it aims to enhance treatment alternatives for patients battling drug-resistant lung cancer.
About BillionToOne
Based in Menlo Park, California, BillionToOne is a pioneering molecular diagnostics firm dedicated to creating highly accurate tests accessible to all. The company's innovative QCT™ platform allows precise counting of DNA molecules at the single-molecule level. For additional information, please visit www.billiontoone.com.
Forward-Looking Statements
This announcement includes forward-looking statements, which are subject to various risks and uncertainties. These statements may relate to future performance and the LC-SCRUM-TRY study’s next phases. Actual outcomes could differ significantly from those projected. Investors are encouraged to review BillionToOne's filings with the Securities and Exchange Commission for detailed risk factors.