BillionToOne Introduces Northstar Select® for Advanced Lung Cancer Study in Japan
On January 6, 2026, BillionToOne, Inc., a pioneering molecular diagnostics firm based in Menlo Park, California, made a significant announcement regarding its collaboration with the National Cancer Center Hospital East (NCCHE) in Japan. The company has been selected to provide its advanced liquid biopsy test, Northstar Select®, for the LC-SCRUM-TRY study, which aims to delve into the challenges of drug resistance in non-small cell lung cancer (NSCLC) patients.
The LC-SCRUM-TRY is an expansive research initiative launched by NCCHE in 2020, consisting of over 100 medical institutions across Japan. This nationwide study is designed to elucidate the mechanisms behind drug resistance in cancer treatment. As part of the study, approximately 2,000 clinical samples have already been analyzed, primarily relying on traditional tissue biopsies from drug-resistant tumors. However, sourcing reliable biopsy samples has proven to be a complex task due to factors such as the challenging locations of tumors and patients being hesitant to undergo invasive procedures.
To address these challenges, the researchers advocated for the use of a non-invasive plasma-based liquid biopsy approach. This method utilizes cell-free DNA (cfDNA), presenting a significant technological advancement over conventional tissue-based genomic testing. Sensitivity in detecting rare genomic alterations in blood samples is a key requirement for the study, prompting the team to seek a more effective liquid biopsy platform that could provide reliable results.
Before endorsing Northstar Select, the research team evaluated the performance of previously utilized liquid biopsy tests. By comparing paired tissue and plasma samples from approximately 1,000 patients with untreated advanced or recurrent NSCLC, they found that the current platform lacked sufficient sensitivity. Northstar Select's distinguished single-molecule next-generation sequencing (smNGS) technology, augmented by its proprietary Quantitative Counting Templates™ (QCT™) system, allows for an unparalleled level of sensitivity and accuracy in quantifying DNA molecules, making it suitable for this critical study.
Recent data published in The Journal of Liquid Biopsy highlighted that Northstar Select provides the highest sensitivity among commercially available liquid biopsy tests, capable of detecting single nucleotide variants (SNVs) and insertions/deletions (indels) as low as 0.15% variant allele frequency. The results of this evaluation, coupled with a successful initial feasibility study, solidified Northstar Select's position as the preferred platform for the LC-SCRUM-TRY initiative starting from November 2025.
Dr. Koichi Goto, Deputy Director of NCCHE, emphasized the importance of this collaboration, stating, "Expanding access to cutting-edge precision medicine tools is a critical need for lung cancer patients in Japan. We are thrilled to incorporate the highly sensitive Northstar Select liquid biopsy into the study, which will facilitate better characterization of drug-resistant lung cancers, leading to more personalized treatment options for affected individuals."
The introduction of Northstar Select represents a major leap forward in the treatment landscape for lung cancer patients. By utilizing this advanced liquid biopsy method, oncologists can now determine the most effective therapies without resorting to invasive procedures, ultimately improving patient care and outcomes in the realm of precision medicine.
Moreover, Northstar Select's validation does not just stop at its performance; it has also met the Medicare coverage criteria set forth by Palmetto GBA, thus ensuring broader accessibility for patients requiring advanced cancer treatments. BillionToOne's Chief Product Officer, Shan Riku, remarked, "Being chosen as the liquid biopsy platform for LC-SCRUM-TRY is a significant validation of Northstar Select's proven sensitivity. We are honored to partner with NCCHE on this vital project that seeks to enhance treatment options for patients battling drug-resistant lung cancer."
In summary, this collaboration between BillionToOne and NCCHE heralds a new era in lung cancer research and treatment in Japan. By integrating Northstar Select into the LC-SCRUM-TRY study, the hope is to bridge the gap in understanding drug-resistant cancer mechanisms and ultimately improving the therapeutic strategies available to these patients. The study is a critical step towards advancing the field of precision oncology and providing new hope for patients facing challenging diagnoses.
The LC-SCRUM-TRY is an expansive research initiative launched by NCCHE in 2020, consisting of over 100 medical institutions across Japan. This nationwide study is designed to elucidate the mechanisms behind drug resistance in cancer treatment. As part of the study, approximately 2,000 clinical samples have already been analyzed, primarily relying on traditional tissue biopsies from drug-resistant tumors. However, sourcing reliable biopsy samples has proven to be a complex task due to factors such as the challenging locations of tumors and patients being hesitant to undergo invasive procedures.
To address these challenges, the researchers advocated for the use of a non-invasive plasma-based liquid biopsy approach. This method utilizes cell-free DNA (cfDNA), presenting a significant technological advancement over conventional tissue-based genomic testing. Sensitivity in detecting rare genomic alterations in blood samples is a key requirement for the study, prompting the team to seek a more effective liquid biopsy platform that could provide reliable results.
Before endorsing Northstar Select, the research team evaluated the performance of previously utilized liquid biopsy tests. By comparing paired tissue and plasma samples from approximately 1,000 patients with untreated advanced or recurrent NSCLC, they found that the current platform lacked sufficient sensitivity. Northstar Select's distinguished single-molecule next-generation sequencing (smNGS) technology, augmented by its proprietary Quantitative Counting Templates™ (QCT™) system, allows for an unparalleled level of sensitivity and accuracy in quantifying DNA molecules, making it suitable for this critical study.
Recent data published in The Journal of Liquid Biopsy highlighted that Northstar Select provides the highest sensitivity among commercially available liquid biopsy tests, capable of detecting single nucleotide variants (SNVs) and insertions/deletions (indels) as low as 0.15% variant allele frequency. The results of this evaluation, coupled with a successful initial feasibility study, solidified Northstar Select's position as the preferred platform for the LC-SCRUM-TRY initiative starting from November 2025.
Dr. Koichi Goto, Deputy Director of NCCHE, emphasized the importance of this collaboration, stating, "Expanding access to cutting-edge precision medicine tools is a critical need for lung cancer patients in Japan. We are thrilled to incorporate the highly sensitive Northstar Select liquid biopsy into the study, which will facilitate better characterization of drug-resistant lung cancers, leading to more personalized treatment options for affected individuals."
The introduction of Northstar Select represents a major leap forward in the treatment landscape for lung cancer patients. By utilizing this advanced liquid biopsy method, oncologists can now determine the most effective therapies without resorting to invasive procedures, ultimately improving patient care and outcomes in the realm of precision medicine.
Moreover, Northstar Select's validation does not just stop at its performance; it has also met the Medicare coverage criteria set forth by Palmetto GBA, thus ensuring broader accessibility for patients requiring advanced cancer treatments. BillionToOne's Chief Product Officer, Shan Riku, remarked, "Being chosen as the liquid biopsy platform for LC-SCRUM-TRY is a significant validation of Northstar Select's proven sensitivity. We are honored to partner with NCCHE on this vital project that seeks to enhance treatment options for patients battling drug-resistant lung cancer."
Conclusion
In summary, this collaboration between BillionToOne and NCCHE heralds a new era in lung cancer research and treatment in Japan. By integrating Northstar Select into the LC-SCRUM-TRY study, the hope is to bridge the gap in understanding drug-resistant cancer mechanisms and ultimately improving the therapeutic strategies available to these patients. The study is a critical step towards advancing the field of precision oncology and providing new hope for patients facing challenging diagnoses.
Topics Health）
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