BillionToOne Expands Northstar Platform with Launch of Two New Add-On Liquid Biopsy Applications for Northstar Select®

Northstar PGx™ and Northstar Select CH™ extend clinical insight and utility of Northstar Select^® all from the same blood-draw

MENLO PARK, Calif., Feb. 10, 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 launch of Northstar PGx and Northstar Select CH. Northstar PGx and Northstar CH are add-on applications for Northstar Select, the most sensitive therapy selection liquid biopsy for advanced solid tumors, as demonstrated in a head-to-head clinical study, proven to uncover 50%+ more clinically actionable alterations.¹ The launch expands the Northstar platform beyond genomic profiling to address chemotherapy safety and clonal hematapoeisis—two critical decision points in selecting the right therapy for patients.

Northstar PGx provides pharmacogenomic insight into key variants in DPYD and UGT1A1, genes recognized in oncology guidelines and FDA labeling for their impact on fluoropyrimidine- (5-FU) and irinotecan-based therapies. The Northstar PGx reports, from the same blood sample, a patient's predicted metabolizer status and associated clinical implications to help inform treatment planning without extending turnaround time. Recent changes to guidelines emphasize the importance of broader testing to avoid potential chemotherapy toxicity (i.e. DPD deficiency testing prior to prescribing capecitabine or fluorouracil (5-FU)²). By integrating pharmacogenomic context directly into the liquid biopsy workflow with the same 5-day average turnaround-time, Northstar PGx supports more informed discussions around dosing, monitoring, and treatment planning—without delaying care.

Northstar Select CH addresses clonal hematopoiesis (CH), a common source of biological false positives in cfDNA testing. The recent literature indicates that in approximately ~25% of patients, at least one clinically actionable or reportable mutation detected by liquid biopsy originates from white blood cells rather than from the tumor, potentially leading to inappropriate or ineffective treatment decisions.^3,4 In particular, ESMO guidelines recommend profiling of white blood cells (WBC) for clinically actionable tumor suppressor genes such as DNA repair genes.⁵ Northstar Select CH combines targeted WBC genomic DNA sequencing for all guideline-recommended genes with proprietary machine-learning classification for all other genes, achieving an impressive 99%+ accuracy in distinguishing tumor-derived clinically actionable alterations from non-tumor findings (>99% PPA, >99% NPA, n=114).⁶ Accurately identifying the origin of alterations found circulating in the blood can optimize treatment confidence and avoid exposing patients to unnecessary toxicity and ineffective treatments.

Together, the new applications reinforce Northstar's commitment to delivering the most sensitive as well as the most specific therapy selection liquid biopsy assay—enabling clinicians to access deeper, clinically relevant insights from a single blood draw while preserving workflow efficiency. "These launches reflect our continued commitment to answering the most critical question oncologists face: which treatment fits the best for my patient. The launch of pharmacogenomics and clonal hematopoiesis applications further empowers oncologists to choose the right therapy for the patients by avoiding potentially ineffective therapies," said Gary Palmer, MD, JD, Chief Medical Officer, Oncology at BillionToOne. "By integrating these assessments into the same workflow, we are expanding what is possible from a single liquid biopsy while simultaneously helping clinicians make more informed decisions, without adding complexity."

Both Northstar PGx and Northstar Select CH are ordered as add-on tests at the time of Northstar Select testing and are integrated into Northstar reporting.

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.

About Northstar Select

Northstar Select, BillionToOne's highly sensitive comprehensive genomic profiling (CGP) liquid biopsy assay, demonstrated superior performance in detecting more clinically actionable alterations in circulating tumor DNA (ctDNA) compared to other liquid biopsy tests on market. In a prospective head-to-head comparison study which included 182 patients with more than 17 solid tumor types, Northstar Select detected 51% more clinically actionable or pathogenic single nucleotide variant (SNV)/Indels and 109% more copy number variants (CNVs) than available comparators, with 45% fewer null reports. When comparing matched CNV coverage between assays, Northstar Select detected almost 40% more CNVs, while the overall comparison across all tested genes showed 109% more, reflecting Northstar Select's broader coverage of copy number losses. The superior sensitivity was validated through orthogonal testing with digital droplet PCR (ddPCR), demonstrating 98% concordance with Northstar Select results and further evidence that the additional alterations found where comparators missed variants were confirmed true positives.¹

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 performance of Northstar PGx and Northstar Select CH. 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 PGx and Northstar CH 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 the company makes 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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SOURCE BillionToOne