BillionToOne Reports Profit in Q3 and Anticipates Up to 100% Revenue Growth in Q4
Financial Performance: BillionToOne Inc. reported a net income of $1.5 million for Q3 2025, a significant turnaround from a net loss of $14.9 million in the same quarter of 2024, with total revenue rising 117% to $83.5 million.
Product Offerings: The company’s core product, UNITY, is a non-invasive prenatal test, while its oncology products include Northstar Select and Northstar Response, which enhance cancer treatment monitoring and therapy selection.
Growth Metrics: The number of tests delivered increased by 52% to 165,000, and gross profit rose to $58.4 million, with a gross margin improvement to 70% due to higher average selling prices and lower costs.
Future Outlook: BillionToOne anticipates Q4 2025 revenue between $84 million and $90 million, projecting full-year revenue growth of 93% to 96% compared to 2024, following a successful IPO that raised approximately $286.4 million in net proceeds.
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- FY2025 Revenue Guidance: BillionToOne reiterated its FY2025 revenue guidance in the range of $293 million to $299 million, expecting to achieve positive GAAP operating income, indicating strong market performance and profitability.
- FY2026 Outlook: The company introduced its FY2026 financial guidance, projecting revenue between $415 million and $430 million, representing approximately 40% to 45% growth compared to the midpoint of the FY2025 guidance, reflecting its strategic commitment to scaling its platform.
- Profitability Expectations: BillionToOne anticipates delivering positive GAAP operating income for FY2026 as well, demonstrating confidence in its future financial health and sustainable growth.
- Market Reaction: Although BillionToOne shares slightly declined by 0.14% to $99.01 during early trading, the positive market response to its financial guidance indicates investor recognition of the company's growth potential.
- 2025 Revenue Outlook: BillionToOne expects fiscal 2025 revenue to range between $293 million and $299 million, indicating stable growth potential in the molecular diagnostics sector, with positive net operating income anticipated.
- 2024 Performance Review: For fiscal 2024, BillionToOne reported revenue of $153 million, reflecting significant growth compared to the previous year and demonstrating the company's increasing competitiveness in the market.
- 2026 Forecast: The company anticipates revenue for fiscal 2026 to be between $415 million and $430 million, with continued positive net operating earnings expected, highlighting strong business expansion and market demand.
- Analyst Expectations: An average of eight analysts forecasts BillionToOne to generate $296.24 million in revenue for 2025 and $393.61 million for 2026, indicating market confidence in the company's future growth trajectory.
- Liquid Biopsy Selection: BillionToOne's Northstar Select has been chosen as the liquid biopsy platform for the LC-SCRUM-TRY study, aimed at analyzing genomic characteristics of approximately 2,000 patients with treatment-resistant non-small cell lung cancer through non-invasive methods, thereby enhancing precision in treatment selection.
- Technical Advantage: The Northstar Select single-molecule NGS platform can detect variant allele frequencies as low as 0.15%, significantly outperforming other commercial liquid biopsy tests, ensuring higher sensitivity in clinical applications to meet patient demands for personalized treatment.
- Clinical Validation: The platform's performance in comparative studies with traditional tissue biopsies has led to meeting Medicare coverage criteria, indicating that more advanced cancer patients will benefit from this innovative technology, promoting the accessibility of precision medicine.
- Strategic Collaboration: The partnership with the National Cancer Center Hospital in Japan marks a significant advancement in treatment options for patients with drug-resistant lung cancer, expected to provide more effective therapies and further solidify the company's leadership in the molecular diagnostics field.

- Liquid Biopsy Selection: BillionToOne's Northstar Select has been chosen as the liquid biopsy platform for the LC-SCRUM-TRY study, aiming to analyze genomic characteristics of approximately 2,000 advanced non-small cell lung cancer patients through a non-invasive method, thereby enhancing understanding and treatment options for drug-resistant cancers.
- Technical Advantage: The single-molecule NGS platform of Northstar Select detects variant allele frequencies as low as 0.15%, significantly outperforming other liquid biopsy tests, ensuring higher sensitivity in clinical applications to meet the urgent precision medicine needs of lung cancer patients in Japan.
- Clinical Validation: In the LC-SCRUM-Asia genetic screening study, Northstar Select demonstrated its accuracy by comparing tumor tissue and plasma samples from about 1,000 patients, facilitating its broader adoption in Japan.
- Medicare Coverage: The test has met Medicare coverage criteria, ensuring that more advanced cancer patients can access personalized treatment options, further enhancing BillionToOne's market position in the molecular diagnostics field.
- Conference Participation: BillionToOne will participate in the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026, from 9:45 AM to 10:25 AM PT, showcasing its innovations in molecular diagnostics.
- Technological Advantage: The company’s patented Quantitative Counting Templates™ (QCT™) molecular counting platform can accurately count DNA molecules at the single-molecule level, enhancing the accuracy and accessibility of molecular diagnostics.
- Investor Relations: A live and archived webcast will be available during the conference, allowing investors to access information through the company’s “Events & Presentations” page, thereby improving investor engagement and transparency.
- Market Positioning: As an emerging molecular diagnostics company, BillionToOne aims to provide powerful and accurate tests to meet the growing market demand, thereby enhancing its influence in the healthcare industry.










