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

Rhea-AI Summary

BillionToOne (NASDAQ: BLLN) launched Northstar PGx and Northstar Select CH as add-on applications to Northstar Select on Feb 10, 2026. The offerings add pharmacogenomic reporting for DPYD and UGT1A1 and clonal hematopoiesis (CH) filtering from the same blood draw.

The company cites >50% more clinically actionable alterations detected by Northstar Select, a ~5-day average turnaround time for integrated PGx, ~25% of liquid-biopsy mutations may originate from white blood cells, and CH classification performance of >99% PPA/NPA (n=114).

Positive

• Adds DPYD and UGT1A1 pharmacogenomics to therapy selection from the same blood draw
• Maintains ~5-day average turnaround time while reporting predicted metabolizer status
• CH filtering reports target WBC DNA plus ML classification with >99% PPA and NPA (n=114)
• Platform previously demonstrated 50%+ more clinically actionable alterations versus comparator

Negative

• None.

Key Figures

Incremental actionable findings: 50%+ more clinically actionable alterations Turnaround time: 5-day average turnaround-time Clonal hematopoiesis prevalence: ~25% of patients +4 more

7 metrics

Incremental actionable findings 50%+ more clinically actionable alterations Head-to-head clinical study of Northstar Select

Turnaround time 5-day average turnaround-time Integrated pharmacogenomic context within liquid biopsy workflow

Clonal hematopoiesis prevalence ~25% of patients Proportion with at least one mutation arising from white blood cells

Classification accuracy 99%+ accuracy Distinguishing tumor-derived alterations from non-tumor findings

Positive percent agreement >99% PPA Performance metric for Northstar Select CH classification

Negative percent agreement >99% NPA Performance metric for Northstar Select CH classification

Study sample size n=114 Validation of CH classification accuracy metrics

Market Reality Check

Price: $92.37 Vol: Volume 166,595 is at 0.74...

normal vol

$92.37 Last Close

Volume Volume 166,595 is at 0.74x the 20-day average of 223,839, indicating muted trading activity pre-announcement. normal

Technical Shares at $92.37 trade below the 200-day MA of $96.20 and sit 33.4% under the 52-week high, 15.46% above the 52-week low.

Historical Context

5 past events · Latest: Jan 15 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 15	Epic integration deal	Positive	+0.4%	Epic collaboration to integrate prenatal and oncology tests into Aura suite.
Jan 12	Revenue guidance update	Positive	+15.4%	Issued 2025 and 2026 guidance implying strong revenue growth and GAAP profitability.
Jan 06	Clinical study adoption	Positive	-0.1%	Northstar Select chosen as new plasma genomic test for LC-SCRUM-TRY study.
Dec 23	Conference participation	Neutral	-9.6%	Participation announcement for the 44th J.P. Morgan Healthcare Conference.
Dec 09	Board appointment	Positive	+4.7%	Appointment of Anthony Pagano as director and Audit Committee Chair.

Pattern Detected

Most prior positive announcements saw aligned positive price reactions, with one small divergence on clinical news.

Recent Company History

Over the past few months, BillionToOne reported several growth-focused milestones, including Epic integration for prenatal and oncology tests on Jan 15, 2026, strong 2025 and 2026 guidance implying ~40%–45% revenue growth on Jan 12, 2026, and selection of Northstar Select for the LC-SCRUM-TRY clinical study on Jan 6, 2026. The new launch of Northstar PGx and Northstar Select CH extends this trajectory by broadening the Northstar platform’s clinical utility from a single blood draw.

Market Pulse Summary

This announcement expands BillionToOne’s Northstar platform with PGx and clonal hematopoiesis add-on...

Analysis

This announcement expands BillionToOne’s Northstar platform with PGx and clonal hematopoiesis add-ons, aiming to deliver more actionable insights from a single liquid biopsy. Reported performance includes 50%+ more clinically actionable alterations and 99%+ accuracy in origin classification (n=114). In context of recent guidance pointing to strong growth, investors may monitor adoption of these add-ons, guideline alignment, and real-world performance data.

Key Terms

liquid biopsy, pharmacogenomic, clonal hematopoiesis, cfDNA, +4 more

8 terms

liquid biopsy medical

"the most sensitive therapy selection liquid biopsy for advanced solid tumors"

A liquid biopsy is a laboratory test that looks for tiny pieces of tumor or disease-related material — such as DNA, proteins, or cells — circulating in blood or other body fluids, allowing detection and monitoring without a surgical tissue sample. For investors, it matters because these tests can speed diagnosis, guide treatment choices, enable easier repeat testing, and create recurring revenue streams if adopted widely, affecting a medical company's growth and regulatory risk profile.

pharmacogenomic medical

"Northstar PGx provides pharmacogenomic insight into key variants in DPYD and UGT1A1"

Pharmacogenomic describes how a person’s genetic makeup influences their response to medicines; it’s the study and application of genetic information to predict who will benefit, who will need a different dose, or who might suffer side effects. For investors, pharmacogenomics matters because it can shrink the risk of drug failure, enable targeted therapies and companion tests, and help companies reach the right patients faster—like tailoring a recipe to individual tastes to improve the outcome.

clonal hematopoiesis medical

"Northstar Select CH addresses clonal hematopoiesis (CH), a common source of biological false positives"

Clonal hematopoiesis is a common, age‑related condition in which certain blood stem cells acquire DNA changes and produce a larger share of circulating blood cells, like a few trees in a forest growing taller than the rest. It matters to investors because those altered blood cell clones are linked to higher risk of blood cancers and heart disease, can skew blood‑based tests, and influence drug safety and the market for diagnostics and therapies.

cfDNA medical

"a common source of biological false positives in cfDNA testing"

Cell-free DNA (cfDNA) is short fragments of genetic material that float freely in the bloodstream after cells die and release their contents. Investors care because cfDNA can be sampled with a simple blood draw to reveal signs of pregnancy complications, organ damage, or cancer without invasive procedures, making it the basis for high-growth diagnostic tests, monitoring tools and companion products that can change how diseases are detected and treated.

machine-learning technical

"with proprietary machine-learning classification for all other genes"

Machine-learning is a type of computer software that improves its performance by finding patterns in data rather than following fixed rules. Think of it like a digital apprentice that gets better at tasks — such as spotting customer trends, predicting demand, or automating routine work — the more examples it sees. Investors care because machine-learning can boost revenue, cut costs, create competitive advantages, and introduce new risks tied to data quality and model errors.

tumor suppressor genes medical

"profiling of white blood cells (WBC) for clinically actionable tumor suppressor genes"

Tumor suppressor genes are parts of a cell’s instruction set that act like brakes, slowing or stopping uncontrolled cell growth and helping repair DNA damage; when these genes fail or are missing, cells can grow out of control and form tumors. Investors care because these genes are common targets for diagnostics, therapies and risk assessments—discoveries or tests related to them can change a drug’s prospects, a company’s valuation, or the market for diagnostic tools.

DNA repair genes medical

"tumor suppressor genes such as DNA repair genes"

DNA repair genes are the instructions cells use to spot and fix damage in the genetic code, acting like a maintenance crew that patches errors and prevents breakdowns. For investors, changes or mutations in these genes can be a key signal because they influence disease risk, treatment response, and the development of diagnostics or drugs—so they affect the commercial prospects and regulatory path of biotech and healthcare investments.

white blood cells medical

"mutation detected by liquid biopsy originates from white blood cells rather than from the tumor"

White blood cells are the body’s infection-fighting cells that identify and remove germs, damaged cells, and foreign substances; think of them as the immune system’s security guards patrolling for threats. Investors care because changes in white blood cell counts can be key signals in clinical trials, drug safety, diagnostics and patient health outcomes, affecting regulatory decisions, market demand for treatments, and the financial prospects of medical and biotech companies.

AI-generated analysis. Not financial advice.

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.

Media Contact

billiontoone@moxiegrouppr.com

1. Bower, 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. Head-to-head improvement % determined when compared to the comparator products in the aggregate. Actual percentages may vary depending on the individual comparator liquid biopsy test 2. "FDA Highlights Importance of DPD Deficiency Discussions With Patients Prior to Capecitabine or 5FU Treatment." The ASCO Post, 28 Jan. 2025 3. Magee, D., Domenyuk, V., Abraham, J., Perdigones Borderias, N., Swensen, J., … & Spetzler, D. Characterization of Plasma Cell-Free DNA Variants as of Tumor or Clonal Hematopoiesis Origin in 16,812 Advanced Cancer Patients. Clin Cancer Res. 2025 Jul 1;31(13):2710-2718. doi: 10.1158/1078-0432.CCR-24-3335. 4. Coombs CC , Zehir A , Devlin SM , Kishtagari A , Syed A , Jonsson P , et al. Therapy-related clonal hematopoiesis in patients with non-hematologic cancers is common and associated with adverse clinical outcomes. Cell Stem Cell 2017;21:374–82.e4. 5. Pascual, J., Attard, G., Bidard, FC., Curigliano, G., De Mattos-Arruda., … .& Turner, NC. ESMO recommendations on the use of circulating tumour DNA assays for patients with cancer: a report from the ESMO Precision Medicine Working Group. Ann Oncol. 2022 Aug;33(8):750-768. doi: 10.1016/j.annonc.2022.05.520. Epub 2022 Jul 6. 6. BillionToOne data on file, January 2026.

View original content to download multimedia:https://www.prnewswire.com/news-releases/billiontoone-expands-northstar-platform-with-launch-of-two-new-add-on-liquid-biopsy-applications-for-northstar-select-302683416.html

SOURCE BillionToOne

FAQ

What do Northstar PGx and Northstar Select CH announced by BLLN on Feb 10, 2026 do?

They add pharmacogenomic and clonal hematopoiesis analysis to Northstar Select from one blood draw. According to the company, Northstar PGx reports DPYD and UGT1A1 metabolizer status and Northstar Select CH distinguishes tumor versus WBC-origin alterations.

How fast are results for Northstar PGx when ordered with Northstar Select (BLLN)?

Results keep the same workflow with about a five-day average turnaround time. According to the company, integrating PGx into the liquid biopsy does not extend turnaround time or delay treatment planning.

How accurate is Northstar Select CH at distinguishing tumor-derived mutations for BLLN's test?

Northstar Select CH achieves greater than 99% positive and negative agreement in classification. According to the company, performance was measured with a reported sample size of n=114 and uses WBC sequencing plus machine-learning classification.

Which genes does Northstar PGx report for chemotherapy safety in BLLN's offering?

Northstar PGx reports clinically relevant variants in DPYD and UGT1A1 for fluoropyrimidine and irinotecan therapies. According to the company, these genes are recognized in oncology guidelines and FDA labeling for dosing implications.

Why does BillionToOne say clonal hematopoiesis reporting matters for liquid biopsy users (BLLN)?

CH reporting reduces biological false positives from white blood cells that can mislead treatment choices. According to the company, about 25% of patients may have at least one actionable mutation originating from WBCs rather than tumor.