BillionToOne, Inc.

BillionToOne, Inc. operates in the molecular diagnostics industry, leveraging its proprietary single-molecule next-generation sequencing (smNGS) platform to detect and quantify genetic targets with single-molecule sensitivity. The company's technology addresses the challenge of detecting sparse but clinically crucial disease signals in cell-free DNA (cfDNA), a limitation for traditional next-generation sequencing (NGS) methods. BillionToOne has transitioned from an R&D-focused entity to a commercial organization, establishing itself as a leader in prenatal testing and expanding into oncology diagnostics. The company's competitive advantages are rooted in its breakthrough smNGS platform, category-defining products, ability to deliver rapid growth at scale, and superior efficiency, which it believes are difficult for competitors to replicate.

The core business model revolves around generating revenue from the sale and performance of molecular diagnostic tests ordered by physicians. Revenue is a function of the number of tests ordered and the average selling price (ASP) achieved through reimbursement. The company benefits from a "flywheel effect" where increased test volume facilitates contracting with third-party payors, leading to higher ASPs and further adoption by ordering providers. The business model includes a mix of recurring test usage, evidenced by low customer churn and increasing penetration in existing accounts. Primary customer segments include obstetricians, maternal-fetal medicine specialists, and oncologists. The company also engages in strategic partnerships, such as with Johnson & Johnson, for clinical trial support and companion diagnostic development.

BillionToOne's product portfolio is segmented into prenatal and oncology diagnostics. The prenatal segment, UNITY, launched in 2019, is the first non-invasive prenatal test (NIPT) using cfDNA to provide fetal risk assessment for recessive conditions like sickle cell disease and cystic fibrosis without requiring a paternal sample or invasive procedures. The UNITY Complete portfolio includes UNITY Fetal Risk Screen, UNITY Aneuploidy Screen, UNITY Fetal RhD NIPT, and UNITY Fetal Antigen NIPT. UNITY Fetal Risk Screen, expanded in May 2025 to include up to 14 conditions, provides maternal carrier status and a personalized fetal risk score. UNITY Aneuploidy Screen, launched in 2020, offers >99.7% sensitivity and >99.9% specificity for common trisomies and enhances 22q11.2 Microdeletion Analysis with >95% sensitivity and >99.9% specificity, resulting in an 80% positive predictive value in average risk pregnancies. UNITY Fetal RhD NIPT, also launched in 2020, detects fetal D antigen with 100% concordance with neonatal outcomes and >99.9% sensitivity/specificity, having been ordered for over 150,000 patients. UNITY Fetal Antigen NIPT, launched in 2022, detects key fetal RBC antigens and is the only commercially available test for fetal antigen screening in the United States, demonstrating 100% sensitivity and specificity with a no-call rate of <0.1%. In February 2026, the company launched an expanded Red Blood Cell (RBC) Fetal Antigen NIPT and a first-and-only Platelet Fetal Antigen NIPT. The UNITY Fetal Antigen clinical trial assay (CTA) is also part of a global partnership with Johnson & Johnson for their AZALEA Phase 3 clinical trial. In 2025, 91% of the company's revenue was derived from prenatal tests ¹.

The oncology segment, launched in 2023, includes Northstar Select and Northstar Response. Northstar Select is an ultrasensitive liquid biopsy test for therapy selection in stage III or IV cancer patients, detecting over 50% more actionable solid tumor mutations than conventional liquid biopsies. It has a limit of detection (LOD) of 0.15%, representing a 2-fold higher sensitivity than other assays, and an LOD approximately five to eight times lower for copy number variants (CNVs). Northstar Response is a tissue-free, pan-cancer, smNGS-based liquid biopsy test that quantifies tumor burden at the single molecule level by measuring over 2,200 genomic loci uniquely methylated in cancer, with a significantly lower LOD of 0.01% as of May 2025. This test provides epigenomic insight into dynamic changes in therapy response and has demonstrated high sensitivity for detecting minute changes in cfDNA burden as small as 0.02%. In 2025, 8% of the company's revenue was from oncology tests ¹. Clinical trial support and other services accounted for 1% of revenue ¹.

For the fiscal year ended December 31, 2025, BillionToOne reported total revenue of $305.112 million ², a 100% increase from $152.582 million in 2024 ². Cost of revenue was $96.654 million ³, leading to a gross profit of $208.458 million ⁴ and a gross margin of 68% ⁵. Operating expenses totaled $192.435 million ⁶, comprising $49.384 million in research and development expenses ⁷ and $143.051 million in selling, general and administrative expenses ⁸. Income from operations was $16.023 million ⁹. Net income for the period was $7.454 million ¹⁰, compared to a net loss of $41.570 million in 2024 ¹⁰. Diluted EPS is not explicitly stated. The company's cash and cash equivalents increased due to proceeds from its IPO. As of December 31, 2025, the company had an accumulated deficit of $274.7 million ¹¹. Total debt includes $50 million drawn under the Note Purchase Agreement ¹².

Year-over-year, revenue increased by $152.530 million, or 100% ². This growth was driven by a 51% increase in delivered and billable tests to approximately 610,000 in 2025 from 405,000 in 2024 ¹³, and a 35% increase in the Overall ASP ¹⁴. Gross profit increased by $127.543 million, or 158% ⁴, with gross margin expanding from 53% in 2024 to 68% in 2025 ⁵. This margin improvement was primarily due to an 86% contribution from increased Overall ASP and a 14% contribution from a decrease in Overall Cost Per Test ¹⁵. Research and development expenses increased by $12.788 million, or 35% ⁷, primarily due to a $10.1 million increase in personnel costs, including a $1.6 million increase in stock-based compensation, and a $3.2 million increase in materials, equipment, and overhead ⁷. Selling, general and administrative expenses increased by $51.586 million, or 56% ⁸, driven by a $40.6 million increase in salaries, commissions, and related expenditures, including a $5.2 million increase in stock-based compensation, a $5.3 million increase in facilities and other costs, and a $5.2 million increase in professional fees ⁸. The company achieved net income of $7.454 million in 2025, a significant improvement from a net loss of $41.570 million in 2024 ¹⁰.

Significant operational developments during the period include the expansion of UNITY Fetal Risk Screen's testing menu to include up to 14 conditions in May 2025. In February 2026, the company launched its expanded Red Blood Cell (RBC) Fetal Antigen NIPT and a first-and-only Platelet Fetal Antigen NIPT. The Northstar Select test received Medicare coverage through the MolDX Program in 2025. The Northstar Response assay was updated in May 2025 to include more than 2,200 genomic loci and achieved a significantly lower LOD of 0.01%. The company completed enrollment for its flagship NORTH study in early 2025, with sample and data collection expected to be completed by the end of 2025, and initial results anticipated in 2026. In January 2026, Northstar PGx was launched, and in February 2026, Northstar Select CH was launched, both as add-on applications for Northstar Select. The company also entered into a global partnership with Johnson & Johnson in December 2023 to provide its UNITY Fetal Antigen CTA in the AZALEA Phase 3 clinical trial, with an Investigational Device Exemption (IDE) granted by the FDA in April 2023. A related U.S.-specific Commercialization Agreement with Johnson & Johnson was entered into on July 11, 2025, with an initial payment and subsequent milestone payments up to $13 million ¹⁶. The company also expanded its laboratory operations by entering into a lease for a new 220,000 square feet facility in Austin, Texas, expected to commence by September 30, 2027, and become operational for commercial samples in 2028.

Management anticipates continued growth in test volumes, particularly for prenatal products, driven by the expansion of its sales force into new geographies and increased penetration within existing territories and clinics. The company expects its Overall ASP to benefit from securing additional payor contracts for prenatal tests and from the MolDX coverage decision for Northstar Select, which should lead to lower denial rates by Medicare Advantage payors. Future MolDX submissions for Northstar Response, if successful, are projected to significantly increase its ASPs.

A major growth area for the company is the expansion and improvement of its molecular diagnostic test portfolio, leveraging its smNGS platform and R&D capabilities. In the prenatal market, the company has already expanded from UNITY Fetal Risk Screen to include UNITY Aneuploidy Screen and UNITY Fetal Antigen NIPT, and recently launched expanded Red Blood Cell (RBC) Fetal Antigen NIPT and Platelet Fetal Antigen NIPT in February 2026. In oncology, the company is developing a tissue-free, pan-cancer MRD test, which is expected to be commercially available in the fourth quarter of 2026. Longer-term, the smNGS-based technology is believed to address sensitivity challenges for early-stage cancer detection, with R&D funding for an early detection test included in the five-year strategic plan.

The company plans to continue deploying AI across its entire organization, including laboratory operations, to improve efficiency and productivity. This strategy involves automating labor-intensive processes, such as sample accessioning and reimbursement, to reduce costs and significantly increase productivity. The goal is to continuously improve the ratio of revenue to operating expense, strengthening the company's differentiated financial profile.

Planned capital allocation includes significant investments in research and development to develop new molecular diagnostic assays, enhance existing tests, and expand testing capabilities. The company has also entered into a lease for a new 220,000 square feet laboratory facility in Austin, Texas, expected to commence by September 30, 2027, and open for commercial samples in 2028, which is projected to nearly triple current testing capacity. The company has a debt facility with availability of up to $140.0 million, and an obligation to sell a tranche of notes in the amount of $30 million before March 31, 2026, triggered by achieving trailing six-month revenue of at least $112.5 million and a trailing six-month gross margin of at least 45% ¹⁷.

Management explicitly flagged several structural headwinds and execution risks. The company's limited operating history and rapid growth make future prospects and challenges difficult to evaluate. Dependence on molecular diagnostic tests for revenue means that failure to achieve or maintain commercial success would materially and adversely affect the business. If government and other third-party payors fail to provide adequate coverage and payment, revenue and profitability prospects will be harmed, as reimbursement from these sources represented over 90% of revenue in 2025 and 2024 ¹⁸. The inherent variability of the insurance coverage and reimbursement landscape makes it difficult to predict collected amounts, and if revenue estimates differ materially from recorded revenue, operating results could fall below expectations. The loss of key senior management or inability to attract and retain skilled personnel could adversely affect the business. Damage or inoperability of existing laboratory facilities or the inability to operationalize new facilities in a timely manner could jeopardize testing and R&D efforts. New products may not be clinically effective or achieve significant commercial market acceptance, and recently launched offerings may not be commercially successful.

Geographic, regulatory, and macro factors identified as constraints include international trade policies, such as tariffs, sanctions, and trade barriers, which may adversely affect business, financial condition, results of operations, and prospects. Legislative or regulatory developments like the BIOSECURE Act could materially affect business operations, supply chain, or ability to contract with U.S. government agencies. The company relies on a limited number of suppliers for laboratory instruments and materials, and disruptions could materially and adversely impact the supply chain. The increasing use of social media platforms presents new risks and challenges related to compliance and potential negative publicity. The molecular diagnostics industry is subject to rapid change, which could render current and future products obsolete. The company operates in a heavily regulated industry, and changes in regulations or violations could reduce revenue and adversely affect financial condition. Companion and complementary diagnostic tests require FDA approval, which may not be secured in a timely manner or at all.

The company faces material risks across several domains. Macroeconomic pressures, including geopolitical uncertainty, inflation, rising interest rates, and supply chain issues, could adversely impact business, financial results, and prospects. International trade policies, such as tariffs and trade barriers, may increase costs of raw materials and components, reducing margins and potentially leading to supply chain disruptions. The company relies on a limited number of suppliers for critical laboratory instruments and materials, and any disruption or termination of these relationships could severely impact operations. Legislative or regulatory developments, such as the BIOSECURE Act, could prohibit federal agencies from contracting with entities using biotechnology equipment or services from designated foreign entities, potentially affecting the company's supply chain and eligibility for federal contracts and reimbursement from Medicaid and Medicare. Operationally, the company's limited operating history and rapid growth make future prospects uncertain, and its primary revenue source, molecular diagnostic tests, is highly dependent on continued market adoption and adequate third-party payor reimbursement, which represented over 90% of revenue in 2025 and 2024 ¹⁸. The inherent variability and unpredictability of the insurance landscape make revenue collection uncertain, and significant discrepancies between estimated and actual revenue could cause operating results to fall below expectations. The loss of key senior management or the inability to attract and retain skilled personnel could adversely affect the business. Furthermore, the company has identified material weaknesses in its internal control over financial reporting, and if remediation efforts are ineffective, or if additional weaknesses are identified, its ability to produce timely and accurate financial statements could be impaired. The company also faces risks related to product liability or professional liability claims if tests fail to perform as designed or if results are misinterpreted, potentially leading to substantial damages and reputational harm.

Management's message to shareholders emphasizes the company's mission to transform healthcare through redefining molecular diagnostics, leveraging its revolutionary single-molecule next-generation sequencing (smNGS) platform. They highlight the transition from an R&D-focused company to a proven commercial organization, with over one million smNGS-based tests processed to date, and approximately 616,000 tests processed in 2025 ¹⁹. A key strategic priority is to drive increased adoption of existing products in both prenatal and oncology markets, supported by expanding the sales team and deepening penetration within existing territories and clinics. Another priority is to build upon its extensive library of clinical evidence to support favorable coverage and reimbursement, particularly for Northstar Response, with the flagship NORTH study results expected in 2026. Management also stresses the continued utilization of the smNGS platform and R&D capabilities to efficiently expand and improve its portfolio of category-defining molecular diagnostic tests, including the planned commercial availability of a tissue-free, pan-cancer MRD test in the fourth quarter of 2026. Finally, a significant strategic focus is to continue deploying AI across the entire organization to improve efficiency and productivity, and to leverage its growing clinical dataset with AI to enhance the utility of diagnostics and enable personalized medicine. Management expects to occupy a new 220,000 square feet laboratory facility in Austin, Texas in 2027, with commercial sample processing beginning in 2028, which is expected to nearly triple current testing capacity.