Company Announcements

Ultra-sensitive liquid biopsy is expanding precision medicine access for patients in Japan with treatment-resistant non-small cell lung cancer (NSCLC)

MENLO PARK, Calif. , Jan. 6, 2026 /PRNewswire/ -- BillionToOne, Inc. (Nasdaq: BLLN), a next-generation molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, today announced the selection of Northstar Select^® as the new liquid biopsy in LC-SCRUM-TRY- Japan, a nationwide, multi-center study to better elucidate the mechanisms of drug resistance and the characteristics of drug-resistant lung cancer. Launched by the National Cancer Center Hospital East (Kashiwa, Japan; "NCCHE") in 2020 with over 100 institutions as part of its network, the study analyzed approximately 2,000 clinical specimens from patients with advanced or recurrent non-small cell lung cancer (NSCLC) following drug resistance, with genomic analysis primarily performed using tissue biopsies from drug-resistant tumors.

Obtaining biopsy samples for tissue-based genomic analysis from drug-resistant tumors is often challenging in NSCLC due to reasons such as difficult to biopsy tumor locations, insufficient tumor sample, and patient reluctance to undergo invasive procedures. To overcome these barriers, the investigators adopted plasma-based liquid biopsy using cell-free DNA (cfDNA) genomic analysis as a non-invasive alternative to tissue-based genomic testing.

With sensitivity as a critical performance metric, investigators sought a liquid biopsy platform capable of reliably detecting targetable alterations that may be rare or difficult to uncover in blood. Prior to selecting Northstar Select, the team evaluated the accuracy of a previously used liquid biopsy assay 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 the trial investigators, broader clinical adoption of liquid biopsies in this setting required significantly higher sensitivity.

Northstar Select's single-molecule NGS (smNGS) platform, powered by proprietary QCT™ technology, delivers ultrasensitive and precise quantification of DNA molecules—setting it apart from conventional assays. 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 and achieved the highest sensitivity for therapy selection, reliably detecting SNVs and indels at variant allele frequencies as low as 0.15% (95% LoD).¹ Based on these results and a successful feasibility pilot, Northstar Select was chosen as the preferred liquid biopsy platform for comprehensive genomic analysis in the LC-SCRUM-TRY study, beginning November 2025.

"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," said Koichi Goto, MD, PhD (Deputy Director, NCCHE). "By integrating the highly sensitive Northstar Select 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."

Northstar Select is a comprehensive genomic profiling liquid biopsy that enables oncologists to select the best treatment for advanced cancer patients without the need for an invasive tissue biopsy. In a head-to-head clinical validation study¹, the assay demonstrated higher sensitivity compared to other commercially available liquid biopsy assays that were evaluated. 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 the test's analytical validity, clinical validity, and clinical utility, helping to ensure that more patients with advanced cancer can benefit from uncovering more personalized treatment approaches.

"Being selected as the liquid biopsy platform for LC-SCRUM-TRY is a significant validation of Northstar Select's proven sensitivity," said BillionToOne 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."

About BillionToOne
Headquartered in Menlo Park, California, BillionToOne is a next-generation molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all. The company's patented Quantitative Counting Templates™ (QCT™) molecular counting platform is the only multiplex technology that can accurately count DNA molecules at the single-molecule level. For more information, visit www.billiontoone.com.

Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of federal securities laws. These forward-looking statements generally are identified by the words "believe," "project," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Forward-looking statements in this press release include, but are not limited to, statements regarding the next phase of the LC-SCRUM-TRY study and future performance of Northstar Select. These statements are based on management's current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, some of which are beyond BillionToOne's control. These and additional risks and uncertainties could affect BillionToOne's financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. These risks and uncertainties include, but are not limited to, the clinical effectiveness of Northstar Select, the operations and outcome of clinical studies and those discussed under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operation" and elsewhere in BillionToOne's most recently filed Quarterly Report on Form 10-Q and other filings we make with the Securities and Exchange Commission from time to time. The forward-looking statements in this press release are based on information available to BillionToOne as of the date hereof, and BillionToOne disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing BillionToOne's views as of any date subsequent to the date of this press release.

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¹Bower, X., Wignall, J., Varga, M. G., Zhu, J., O'Sullivan, M., Searle, N. E., ... & Zhou, W. (2025). Validation of a liquid biopsy assay with increased sensitivity for clinical comprehensive genomic profiling. The Journal of Liquid Biopsy. https://doi.org/10.1016/j.jlb.2025.100322.

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SOURCE BillionToOne