BillionToOne, Inc.

What they do

BillionToOne develops and sells non-invasive prenatal tests (NIPT) and pan-cancer liquid biopsy tests based on its proprietary single-molecule next-generation sequencing (smNGS) platform. Its prenatal product line, UNITY, provides fetal risk assessment for recessive conditions and comprehensive prenatal genetics from a maternal blood draw. Its oncology line, Northstar, includes tests for therapy selection, tumor burden monitoring, pharmacogenomics, clonal hematopoiesis, and tissue-of-origin. The company also provides clinical trial support and other services.

Revenue drivers

• Prenatal clinical testing (UNITY) — Largest segment, $94.2M in Q2 2026 (86% of total revenue), +55% YoY, driven by guideline changes, expanded insurance contracts, and higher ASPs.
• Oncology clinical testing (Northstar) — Fast-growing segment, $13.7M in Q2 2026 (13% of total revenue), +176% YoY, driven by adoption of Northstar Select, Response, and new add-on features.
• Clinical trial support and other services — Small segment, $1.5M in Q2 2026, +99% YoY, providing services to pharma/biotech partners.

Recent performance

In Q2 2026, total revenue was $109.4M, up 64% YoY, with total tests delivered up 35% to 196,000 and overall ASP up 21% to $551. Gross margin improved to 70% from 65% YoY, and the company posted income from operations of $5.5M versus an operating loss of $1.6M in Q2 2025. For the six months ended June 30, 2026, revenue was $217.8M, up 74% YoY. The company reiterated 2026 full-year revenue guidance of $450M–$465M.

Strategy

The company plans to expand its prenatal franchise with the largest single-gene NIPT panel (130 genes) and the Unity Confirm non-invasive confirmation assay. In oncology, it is launching add-on features (Northstar PGx, Select CH, Origin) and developing MRD detection. Management emphasizes leveraging smNGS technology, AI-enhanced workflows, and payer contracting to drive ASP and volume growth. It expects to continue generating profitability while investing significantly in growth.

Risks

• Reimbursement concentration — Revenue depends heavily on coverage and adequate payment from government and commercial payors; failure to obtain or maintain reimbursement could harm revenue.
• Competitive pressure — Competitors have launched competing NIPTs for recessive conditions, and the oncology liquid biopsy market is crowded, which could erode market share or pricing.
• Regulatory and billing complexity — Complex billing requirements and potential noncompliance could delay collections or reduce revenue; also subject to evolving FDA and other regulations.
• Internal control weaknesses — The company has identified material weaknesses in internal control over financial reporting, which could lead to errors or delays in financial reporting.

Outlook

Management reiterated 2026 revenue guidance of $450M–$465M, representing 48–52% growth over 2025. They expect to maintain profitability at current levels while continuing to invest. Planned launches include the expanded 130-gene Unity Fetal Risk Screen (August 17, 2026) and Northstar Origin (September 1, 2026). Cash position remains strong with $548.6M in cash and equivalents as of June 30, 2026.