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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) has appointed renowned oncology physician-scientist Ethan Dmitrovsky, MD as Chief Medical Officer, Oncology, effective July 20, 2026. He will lead medical strategy for the Northstar liquid biopsy portfolio, focusing on expanding clinical adoption in solid-tumor treatment decisions and driving the company’s entry into minimal residual disease (MRD) testing.
According to BillionToOne, Dmitrovsky brings leadership experience from Frederick National Laboratory, MD Anderson Cancer Center, and Dartmouth, along with a track record of translating cancer research into FDA-approved therapies. The Northstar portfolio includes Northstar Select and Northstar Response plus recent launches Northstar PGx and Northstar Select CH.
BillionToOne (NASDAQ: BLLN) will release its financial results for the second quarter ended June 30, 2026 after market close on Wednesday, August 5, 2026. The company will host a conference call at 1:30pm Pacific / 4:30pm Eastern the same day.
Analysts must register in advance to participate, and a live and archived webcast will be accessible via the Events page on BillionToOne’s investor relations website.
BillionToOne (Nasdaq: BLLN) reported peer-reviewed data showing its Northstar Response tissue-free ctDNA assay was a stronger independent predictor of survival than standard-of-care imaging in 142 advanced solid tumor patients across 12 tumor types receiving immunotherapy.
Molecular progression via Northstar Response showed a hazard ratio of 5.3 for survival and identified progression a median of 62 days before clinicoradiographic imaging. Combining Northstar Response with imaging produced the highest predictive discrimination, with hazard ratios up to 19.7 when both modalities indicated progression.
BillionToOne (NASDAQ:BLLN) announced that management will participate in the William Blair 46th Annual Growth Stock Conference. The company will present from 12:40pm to 1:10pm CT on Tuesday, June 2, 2026.
A live and archived webcast will be available on the Events & Presentations page of BillionToOne’s investor relations website.
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.