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BillionToOne, Inc. reports developments in molecular diagnostics, with news centered on its QCT molecular counting platform, prenatal testing franchise and Northstar oncology liquid biopsy portfolio. Recurring updates cover financial results, revenue guidance, test volumes, product launches and leadership changes tied to the company’s clinical testing operations.
The company’s prenatal news includes UNITY products for non-invasive prenatal testing, fetal antigen testing and Unity Confirm, a circulating fetal cell-based confirmation test. Oncology updates focus on Northstar Select, Northstar Response and add-on liquid biopsy applications such as Northstar PGx and Northstar Select CH for therapy-selection and related clinical insights.
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).
BillionToOne (Nasdaq: BLLN) launched expanded UNITY Red Blood Cell Fetal Antigen NIPT and the first-and-only Platelet Fetal Antigen NIPT in the U.S., available through the UNITY Aneuploidy Screen. The RBC expansion adds 10 antigens, covering ~99% of HDFN-associated antigens. UNITY studies report >99.9% sensitivity and specificity and 100% neonatal concordance, and recent JAMA Network guideline updates endorse cfDNA testing to determine fetal antigen status, reducing unnecessary surveillance for antigen-negative pregnancies. The platelet test addresses FNAIT risk where routine antibody screening is unavailable, enabling non-invasive fetal antigen determination and earlier risk stratification.
BillionToOne (NASDAQ: BLLN) announced a collaboration with Epic to integrate its prenatal and oncology tests into Epic's Aura diagnostics suite. The agreement, signed in December 2025, enables clinicians to order UNITY Complete prenatal testing and Northstar Select and Northstar Response liquid biopsy tests directly in Epic, with discrete results flowing back into the EHR and MyChart. The integration aims to simplify ordering, speed clinical decision making, and improve the patient and provider experience across health systems, maternal-fetal medicine, and oncology settings.
BillionToOne (NASDAQ: BLLN) reiterated full year 2025 guidance of $293 million to $299 million and initiated full year 2026 guidance of $415 million to $430 million, implying ~40%–45% revenue growth versus the midpoint of 2025 guidance. The company guided to positive GAAP operating income for both the remainder of 2025 (reiterated) and for full year 2026. Management cited a roadmap to scale its molecular diagnostics platform and deliver a durable, high-quality growth profile in 2026.
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.
BillionToOne (NASDAQ: BLLN) announced management will participate in the 44th Annual J.P. Morgan Healthcare Conference.
The presentation is scheduled for Monday, January 12, 2026, from 9:45 AM to 10:25 AM PT. A live and archived webcast will be available on BillionToOne's Events & Presentations investor page at https://investors.billiontoone.com/news-events/events-presentations.
BillionToOne (NASDAQ: BLLN) announced the appointment of Anthony Pagano to its Board of Directors, effective January 1, 2026, and named him Chair of the Audit Committee.
Pagano is currently CFO and Executive Vice President of Genmab since March 2020 and previously joined Genmab in December 2007. During his tenure at Genmab, annual revenues grew from $100M to more than $3B. He began his career at KPMG, served in senior finance roles at NovaDel Pharma, is a Certified Public Accountant, holds a B.S. in Accounting and an M.B.A. from NYU Stern.
Company leaders said Pagano's financial experience will support BillionToOne's growth and governance as it advances its molecular diagnostics strategy.
BillionToOne (NASDAQ: BLLN) reported strong third-quarter 2025 results and issued full-year guidance. Total revenue was $83.5M in Q3 2025, up 117% year-over-year; prenatal revenue was $74.1M (+102%) and oncology revenue was $8.7M (+664%).
Gross margin improved to 70% (vs. 53% prior year); operating income was $9.6M and net income available to common shareholders was $1.5M ($0.10 diluted). The company accessioned 162,900 tests in Q3 and delivered 165,000 tests.
Company raised $314.0M gross proceeds in its IPO and ended September 30, 2025 with approximately $195.2M cash. BillionToOne expects 2025 revenue of $293M–$299M and positive GAAP operating income for Q4 and full-year 2025.
BillionToOne (NASDAQ: BLLN) will release financial results for the third quarter ended September 30, 2025 after market close on Tuesday, December 9, 2025. The company will host a conference call to discuss results at 1:30 PM PT / 4:30 PM ET the same day.
Investors must register to participate in the call before the start time. A live and archived webcast will be available on the company’s Events page at https://investors.billiontoone.com/.
BillionToOne (NASDAQ: BLLN) closed an upsized initial public offering on Nov 7, 2025, selling 5,233,765 shares of Class A common stock, which includes full exercise of the underwriters’ option for an additional 682,665 shares.
The public offering price was $60.00 per share, and the aggregate gross proceeds were approximately $314.0 million before underwriting discounts, commissions and estimated offering expenses. BillionToOne began trading on the Nasdaq Global Select Market on Nov 6, 2025 under the ticker BLLN.