Billiontoone (NASDAQ:BLLN) used its presentation at the JPMorgan Healthcare Conference to highlight what management described as a “single molecule” next-generation sequencing platform that it believes can deliver substantially higher sensitivity and precision in cell-free DNA testing. The company framed its strategy around four pillars: a patented technology foundation, rapid revenue growth, a high gross margin model with room to improve, and emerging GAAP profitability supported by cost discipline and operational efficiency.
Technology focus: QCTs and “single molecule” sequencing
Management said the company’s core platform is built around quantitative counting templates (QCTs), synthetic DNA molecules added to a sample prior to amplification and sequencing. According to the presentation, embedding identifiers in QCTs allows the company to measure amplification and sequencing errors and remove noise from data—an issue it characterized as the key limiting factor in very low detection settings such as minimal residual disease (MRD) and early cancer detection.
Prenatal diagnostics: UNITY and fetal risk assessment
In prenatal care, BillionToOne discussed its UNITY offering as a single maternal blood test intended to assess fetal risk for recessive conditions without requiring partner testing. Management described the existing carrier screening workflow as highly inefficient due to incomplete paternal testing, and said UNITY can identify fetal risk directly from the maternal sample.
The company said its approach enables detection moving from large chromosomal changes down to single base-pair changes for conditions such as cystic fibrosis and sickle cell disease. Management asserted that, compared with traditional carrier testing workflows, UNITY can detect three times as many affected pregnancies when partner testing is frequently absent.
Management also provided anecdotal provider feedback and cited a specific patient case (noting it had been referenced in the news) in which UNITY flagged high risk for cystic fibrosis that was confirmed via amniocentesis. In that case, prenatal therapy was initiated at 27 weeks, and the baby reportedly avoided a NICU stay and passed newborn screening, which management said underscored how earlier diagnosis can change treatment timing.
Oncology diagnostics: Northstar Select and Northstar Response
In oncology, the company discussed two products under its Northstar brand:
- Northstar Select, aimed at therapy selection through an ultrasensitive liquid biopsy.
- Northstar Response, aimed at monitoring treatment response by quantifying tumor burden at single-molecule resolution.
Management said providers often use Select and Response together, using Select to determine therapy and Response as a baseline and follow-up tool, with additional Select testing when response indicates loss of efficacy. The company emphasized that both tests are “tumor-naive” and tissue-free.
BillionToOne highlighted a prospective head-to-head clinical study in which it said Northstar Select detected 51% more single nucleotide variants (SNVs) and 109% more copy number variants (CNVs) than competing tests. Management also cited an immunotherapy pan-cancer cohort where Northstar Response separated responders from non-responders by more than two years in a late-stage cancer setting.
As an example of clinical impact, management described a patient in their 30s with stage II rectal cancer where tissue sequencing did not identify a key feature, but a Northstar Select test detected MSI-high status from blood, enabling a switch from chemotherapy to anti-PD-1 therapy. Management said the treating physician subsequently became a strong proponent of liquid biopsy.
Growth, contracting progress, and profitability targets
The company reported that it reached a $334 million annualized revenue run rate as of the end of Q3, reflecting growth from $0 over five years, and said test volume grew 51% year-over-year. It also said it has exceeded 250 million contracted lives, describing in-network expansion as a key lever for adoption, particularly in prenatal testing. Management noted its sales force is smaller than many competitors, and said existing sales reps add roughly 100 new clinics per quarter on average, with “100% net test retention” for most clinic cohorts.
BillionToOne said its average selling price has risen to more than $500 per test, attributing gains to progress in coding, contracting, and coverage. It also pointed to remaining opportunities, including Medicare coverage for its oncology response tests, which management said it is working on “this year.”
On margins, the company said it has achieved about 70% blended gross margins and argued there is additional upside given it is using about one-quarter of lab capacity and still sees opportunities to reduce cost per test. It cited more than 100 cost-of-goods projects, each contributing incremental reductions, and described labor productivity improvements as volumes scale.
Management also emphasized GAAP profitability, stating it achieved GAAP profitability and positive cash flows as of Q3 and that it has guided full-year 2025 and 2026 to be GAAP operating margin positive. In Q&A, management said it expects gross margins in 2026 to be similar to late 2025 levels (described as “high 60-ish%”), with operating income depending on investment choices in SG&A and R&D, but said it expects to be “solidly GAAP profitable” on an operating income basis.
Outlook: 2025–2026 revenue guidance and pipeline priorities
The company reviewed its recent forecasting history and updated guidance. It said it delivered $72 million in revenue in 2023 and $153 million in GAAP revenues in 2024. For 2025, it guided to $293 million–$299 million and said it expects to be “easily in the upper end” of the range. For 2026, it initiated revenue guidance of $415 million–$430 million. In Q&A, management said it is not yet breaking out prenatal versus oncology guidance, but expects oncology to grow faster given a lower base.
On product expansion, management said it expects to expand into MRD this year, describing it as a $30 billion opportunity, and reiterated its belief that the same noise-related challenge that affects tumor-naive MRD is central to early detection. For MRD data generation, management said studies will span major cancer types, with initial data expected first in colorectal cancer to facilitate head-to-head comparisons because that indication has extensive existing data from others.
In prenatal commercialization, management said one growth initiative is investment in Epic Aura integration, noting it is now an Epic Aura partner and expects this to help penetrate health systems.
About Billiontoone (NASDAQ:BLLN)
BillionToOne (NASDAQ: BLLN) is a molecular diagnostics company that develops and commercializes high-precision genetic testing solutions based on single-molecule counting technology. The company’s platform is designed to detect and quantify rare genetic variants and chromosomal abnormalities from cell-free DNA, with a primary focus on applications in prenatal screening and other clinical genetic tests where sensitivity and specificity at very low allele fractions are critical.
BillionToOne’s offerings center on assay development and clinical testing workflows that enable non-invasive prenatal testing (NIPT) and targeted molecular diagnostics.
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