BillionToOne Announces Selection of Northstar Select® as the new liquid biopsy test for LC-SCRUM-TRY clinical study at National Cancer Center Hospital East

Rhea-AI Summary

BillionToOne (NASDAQ: BLLN) announced that its Northstar Select liquid biopsy was selected as the new plasma-based genomic test for LC-SCRUM-TRY (Japan) at National Cancer Center Hospital East, effective November 2025. The platform uses single-molecule NGS with QCT technology and, per a peer-reviewed prospective head-to-head study, achieved the highest sensitivity among evaluated commercial assays and a 95% LoD down to 0.15% variant allele frequency. The test also met Palmetto GBA MolDx Medicare coverage criteria.

Positive

• Selected for LC-SCRUM-TRY nationwide study starting Nov 2025
• Peer-reviewed head-to-head study: highest sensitivity vs peers
• 95% LoD at 0.15% VAF for SNVs and indels
• Met Palmetto GBA MolDx Medicare coverage criteria

Negative

• None.

News Market Reaction – BLLN

-0.13%

1 alert

-0.13% News Effect

On the day this news was published, BLLN declined 0.13%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

LC-SCRUM-TRY network sites: over 100 institutions Clinical specimens analyzed: approximately 2,000 specimens Paired samples evaluated: approximately 1,000 patients +5 more

8 metrics

LC-SCRUM-TRY network sites over 100 institutions National Cancer Center Hospital East network in Japan

Clinical specimens analyzed approximately 2,000 specimens Advanced or recurrent NSCLC after drug resistance

Paired samples evaluated approximately 1,000 patients LC-SCRUM-Asia genetic screening study

Detection sensitivity 0.15% variant allele frequency SNVs and indels at 95% LoD for therapy selection

Study start with Northstar November 2025 Northstar Select as preferred liquid biopsy in LC-SCRUM-TRY

Q3 2025 revenue $83.5M Total revenue, up 117% year-over-year

Oncology revenue $8.7M Q3 2025 oncology revenue, up 664%

IPO gross proceeds $314.0M Aggregate gross proceeds from Nov 7, 2025 IPO

Market Reality Check

Price: $85.31 Vol: Volume 385,374 is 1.78x t...

high vol

$85.31 Last Close

Volume Volume 385,374 is 1.78x the 20-day average of 216,547 shares. high

Technical Shares at 95.00 are trading below the 200-day MA of 100.94, despite today’s gain.

Peers on Argus

No peers were flagged in the momentum scanner and no sector-wide moves were dete...

No peers were flagged in the momentum scanner and no sector-wide moves were detected, suggesting BLLN’s 6.39% move reflected a company-specific reaction to the LC-SCRUM-TRY news.

Historical Context

5 past events · Latest: Dec 23 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 23	Conference participation	Neutral	-9.6%	Announced participation in the 44th Annual J.P. Morgan Healthcare Conference.
Dec 09	Board appointment	Positive	+4.7%	Appointed experienced CFO Anthony Pagano as Audit Committee Chair.
Dec 09	Earnings results	Positive	+4.7%	Reported strong Q3 2025 growth, higher margins, and positive income guidance.
Dec 02	Earnings date set	Positive	+1.7%	Scheduled Q3 2025 earnings release and investor conference call details.
Nov 07	IPO and offering	Positive	+2.2%	Closed upsized IPO with full exercise of the underwriters’ option.

Pattern Detected

Recent positive corporate and financial news has generally aligned with favorable one-day price reactions.

Recent Company History

Over the past few months, BillionToOne has transitioned from IPO to strong operational execution. The company closed its upsized IPO on Nov 7, 2025, then reported robust Q3 2025 results with revenue of $83.5M and raised guidance on Dec 9, 2025, which coincided with a positive price move. Governance was strengthened with a new Audit Committee Chair effective Jan 1, 2026. Today’s clinical collaboration in LC-SCRUM-TRY extends this trajectory by highlighting adoption of its Northstar Select technology in a major Japanese lung cancer study.

Market Pulse Summary

This announcement highlights Northstar Select’s selection as the new liquid biopsy for LC-SCRUM-TRY ...

Analysis

This announcement highlights Northstar Select’s selection as the new liquid biopsy for LC-SCRUM-TRY in Japan, reflecting peer-reviewed data showing detection of variants at 0.15% allele frequency and Medicare coverage via MolDx. It builds on prior milestones, including strong Q3 2025 revenue of $83.5M and oncology growth. Investors may watch how specimen volumes from LC-SCRUM-TRY and further validation data influence long-term adoption of Northstar Select in treatment-resistant NSCLC.

Key Terms

liquid biopsy, non-small cell lung cancer, cell-free DNA, ngs, +4 more

8 terms

liquid biopsy medical

"Ultra-sensitive liquid biopsy is expanding precision medicine access for patients"

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.

non-small cell lung cancer medical

"treatment-resistant non-small cell lung cancer (NSCLC)"

A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.

cell-free DNA medical

"plasma-based liquid biopsy using cell-free DNA (cfDNA) genomic analysis"

Fragments of DNA that float freely in the bloodstream after being released by dying or damaged cells, like puzzle pieces carried downstream that hint at what’s happening upstream. Investors care because measuring these fragments enables non‑invasive tests — for example to detect cancer, monitor treatment response, check pregnancy health, or spot organ rejection — so advances, approvals, or reimbursement changes can quickly affect companies that develop the tests and related technologies.

ngs technical

"Northstar Select's single-molecule NGS (smNGS) platform"

A laboratory method that reads large amounts of DNA or RNA quickly to identify genetic differences, mutations, or microbes, similar to scanning many pages of a book at once to find important words. Investors care because it drives diagnostics, drug discovery and personalized treatments, can create recurring revenue from testing services and instruments, and influences regulatory approvals, partnerships and market value in biotech and healthcare companies.

snvs medical

"reliably detecting SNVs and indels at variant allele frequencies"

SNVs (single nucleotide variants) are changes to a single “letter” in the DNA sequence, like a one-letter typo in a long instruction manual for a cell. Investors care because those tiny changes can alter how a disease behaves, how patients respond to treatments, or whether a diagnostic test can detect a condition, all of which directly affect the value, risk and commercial prospects of drugs, tests and biotech programs.

indels medical

"reliably detecting SNVs and indels at variant allele frequencies"

Indels are small insertions or deletions of DNA “letters” that add or remove genetic material and can change how a gene is read or how a protein functions. For investors, indels matter because they can alter disease mechanisms, affect the performance of diagnostics and therapies, and influence clinical trial outcomes, regulatory decisions and commercial value—imagine adding or removing words from a recipe that makes the dish turn out very different.

variant allele frequencies medical

"indels at variant allele frequencies as low as 0.15% (95% LoD)"

Variant allele frequencies are the proportion of DNA molecules in a biological sample that carry a specific genetic change, expressed as a percentage or fraction. Like counting how many colored marbles are in a jar, this measure tells investors and clinicians how common a mutation is within a tumor or patient sample, which influences diagnostic accuracy, likelihood a targeted therapy will work, and the size and risk of related commercial opportunities.

medicare regulatory

"The test has met Medicare coverage criteria established by Palmetto GBA"

Medicare is a large government-run health insurance program that primarily covers people aged 65 and older and certain younger people with disabilities. For investors it matters because Medicare acts like a huge customer and rule-maker for hospitals, drugmakers and medical-device companies—its coverage decisions, payment rates and regulatory policies can change demand, revenue and profit margins across the healthcare sector, similar to how a major client or regulator can shape a business’s prospects.

AI-generated analysis. Not financial advice.

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.

Media Contact
billiontoone@moxiegrouppr.com 

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

FAQ

What change did BillionToOne (BLLN) announce for LC-SCRUM-TRY Japan?

BillionToOne's Northstar Select was chosen as the new plasma-based liquid biopsy for LC-SCRUM-TRY, starting November 2025.

How sensitive is Northstar Select according to the announcement?

The test demonstrated a 95% limit of detection at 0.15% variant allele frequency for SNVs and indels in a peer-reviewed head-to-head study.

Does Northstar Select have Medicare coverage recognition?

Yes; the test met Palmetto GBA MolDx Medicare coverage criteria after review of analytical and clinical validity.

Why did LC-SCRUM-TRY investigators switch to a liquid biopsy for NSCLC?

Investigators cited difficulty obtaining tissue biopsies in drug-resistant NSCLC and the need for a plasma test with significantly higher sensitivity to detect targetable alterations.

What technology underpins Northstar Select used by BillionToOne (BLLN)?

Northstar Select uses a single-molecule NGS (smNGS) platform powered by proprietary QCT technology for ultrasensitive DNA quantification.