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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) reported Q1 2026 revenue of $108.4M, up 84% year-over-year, driven by prenatal revenue of $96.5M and oncology revenue of $10.7M.
Key metrics: 188,000 tests delivered, overall ASP $571, gross margin 73%, net income $18.0M ($0.34 diluted). The company raised 2026 revenue guidance to $450M–$465M (48%–52% growth).
BillionToOne (Nasdaq: BLLN) launched Unity Confirm on May 1, 2026, a circulating fetal cell–based non‑invasive confirmation test that analyzes intact fetal cells from a maternal blood draw.
In internal validation, Unity Confirm showed 16/16 concordance with invasive diagnostic outcomes; access opens May 28 for Unity Aneuploidy users and a 1,000‑patient prospective study is enrolling.
BillionToOne (NASDAQ: BLLN) will report first quarter 2026 financial results after market close on May 6, 2026. The company will host a conference call at 1:30pm PT / 4:30pm ET that day to discuss results and provide a live webcast.
Analysts must register before the 1:30pm PT start. A live and archived webcast will be available on BillionToOne's Events page at https://investors.billiontoone.com/.
BillionToOne (Nasdaq: BLLN) named Allen Chen, MD, MBA, FASTRO, FACHE, as Vice President of Medical Affairs and Clinical Development, Oncology, effective April 2, 2026. Dr. Chen brings more than 20 years of physician-executive experience and will lead clinical and translational strategy for the company's Northstar oncology portfolio.
The company also announced that Gary Palmer, MD, is retiring as Chief Medical Officer, Oncology, and will remain in a CMO emeritus advisory role as BillionToOne advances its Northstar Select (84-gene ctDNA panel) and Northstar Response (methylation-based pan-cancer assay).
BillionToOne (NASDAQ: BLLN) reported strong Q4 and full‑year 2025 results and raised 2026 revenue guidance. Q4 revenue was $96.1M (+113% YoY); FY2025 revenue was $305.1M (+100% YoY). Gross margin improved to 71% in Q4 and operating income turned positive for 2025. Management raised 2026 revenue guidance to $430M–$445M and expects positive GAAP operating income.
Deliveries totaled 170,000 tests in Q4 and overall ASP rose to $561 in Q4, with $496M cash on hand as of Dec 31, 2025.
BillionToOne (NASDAQ: BLLN) announced it will report fourth quarter and full year 2025 financial results after market close on March 4, 2026. The company will host a conference call at 1:30 PM PT / 4:30 PM ET the same day and provide a live and archived webcast.
Investors may register to participate in the conference call and access the webcast on BillionToOne's investor relations "Events" page.
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.