Sacra estimates BillionToOne hit $153M in revenue in 2024, more than doubling from $72M in 2023, representing 112% year-over-year growth. The company projects reaching $220M in 2025 and $330M in 2026, maintaining strong growth momentum.

The company generates revenue primarily through its prenatal testing business, which has captured 15% market share in the US and is profitable. Average selling prices for prenatal tests are approaching $400, with costs dropping toward $100 per test, driving expanding gross margins above 60%.

BillionToOne's oncology segment, launched in early 2023, has rapidly scaled to thousands of tests per quarter, reaching approximately 3,000 tests in Q4 2024. This expansion into the $50B+ oncology market represents a significant growth vector, complementing the established prenatal business.

BillionToOne reached a valuation of over $1 billion following a $130 million Series D financing round. The company secured an additional $140 million in non-dilutive credit facility financing in late 2024.

Based on the company's 2024 revenue, this implies a valuation multiple of approximately 6.5x LTM.

BillionToOne was founded in 2016 by Oguzhan Atay and David Tsao to revolutionize genetic screening through their proprietary Quantitative Counting Template (QCT) molecular counting platform.

The company found product-market fit with their UNITY Screen, a non-invasive prenatal test that enables comprehensive genetic screening from a single maternal blood draw, eliminating the need for paternal DNA samples. This resonated strongly with OB/GYN practices seeking simplified workflows for genetic screening.

UNITY screens for common inherited disorders like cystic fibrosis, spinal muscular atrophy, and sickle cell disease by analyzing cell-free fetal DNA in maternal blood. Healthcare providers collect a standard blood sample from the pregnant mother, which is sent to BillionToOne's CLIA-certified laboratory for analysis. Results are typically available within 5-10 days.

The company has since expanded into oncology with their Northstar platform, which applies the same QCT technology to detect cancer mutations in blood samples. Northstar Select provides comprehensive genomic profiling for therapy selection, while Northstar Response monitors treatment effectiveness through quantitative measurement of circulating tumor DNA. The platform enables oncologists to detect treatment response significantly earlier than traditional imaging methods.

BillionToOne is a molecular diagnostics company that monetizes through insurance reimbursement for genetic testing, primarily focusing on prenatal screening and oncology diagnostics. The company processes tests in CLIA-certified laboratories using its proprietary Quantitative Counting Template (QCT) technology.

The company's flagship UNITY prenatal screen leverages existing CPT codes for carrier testing reimbursement, while providing additional value through single-gene disorder detection without requiring paternal DNA samples. This unique capability allows BillionToOne to capture market share from traditional carrier screening methods while maintaining similar reimbursement rates.

In oncology, BillionToOne's Northstar Select and Response tests target the therapy selection and monitoring markets. The company employs a land-and-expand strategy, initially targeting individual providers within practices to drive adoption. As providers see success with one product line, BillionToOne cross-sells additional testing services.

The business model benefits from significant operational leverage as test volumes increase. While each test requires reagents and processing, the company's proprietary technology and automated workflows help drive down per-test costs. The centralized lab model also allows BillionToOne to maintain quality control while scaling operations efficiently through automation and standardized processes.

BillionToOne operates in a molecular diagnostics market that includes both prenatal testing and liquid biopsy segments, with distinct competitive dynamics in each area.

Natera dominates the U.S. NIPT market with approximately 60% market share, followed by established players like LabCorp/Sequenom, Quest Diagnostics, and Myriad Genetics. These companies primarily focus on chromosomal abnormality detection, while BillionToOne's UNITY test differentiates by offering single-gene disorder screening without requiring paternal DNA.

The liquid biopsy space features both public companies and well-funded startups. Guardant Health and Foundation Medicine lead in comprehensive genomic profiling, with established clinical validation and broad commercial adoption. Natera's Signatera has gained traction in minimal residual disease (MRD) monitoring, while Grail focuses on early cancer detection.

A separate category of competitors approaches the market through technology licensing rather than direct testing services. Illumina provides the underlying sequencing technology used by many players, while companies like Roche develop both testing platforms and diagnostic services. These companies often partner with or acquire innovative startups to expand their capabilities.

The competitive landscape is evolving as traditional prenatal testing companies expand into oncology, while oncology-focused companies increasingly move into earlier disease detection. Market success increasingly depends on demonstrating superior clinical utility and cost-effectiveness rather than just technical capabilities.

BillionToOne has tailwinds from the rapid growth in molecular diagnostics and precision medicine, with opportunities to expand beyond its current prenatal and oncology testing markets into broader applications of its QCT platform technology.

The core prenatal testing market is projected to reach $9-10B by 2028, but BillionToOne's QCT platform enables expansion into the broader molecular diagnostics space. The platform's ability to detect single base pair changes with high precision opens opportunities in rare disease testing, pharmacogenomics, and infectious disease diagnostics.

The liquid biopsy market represents a $50B+ opportunity across therapy selection ($6B), monitoring ($15B), and minimal residual disease detection ($30B). BillionToOne's technology demonstrates superior detection capabilities, identifying 51% more actionable mutations than competitors. The company's rapid scaling from 0 to thousands of oncology tests in 8 quarters suggests strong product-market fit.

BillionToOne's QCT platform could be leveraged for additional revenue streams through licensing or partnerships. The technology's demonstrated 2-5x lower limit of detection compared to traditional methods makes it valuable for pharmaceutical companies developing precision therapies or other diagnostic companies seeking improved sensitivity. Early detection of treatment response (191 days earlier than competitors) could create opportunities in clinical trial optimization and therapy development partnerships.

The company's proven ability to achieve 60%+ gross margins while scaling revenue at 75%+ CAGR demonstrates the platform's operational leverage and potential for profitable expansion into adjacent markets.

Technology dependence in oncology expansion: The Northstar platform's success relies heavily on maintaining superior detection capabilities compared to competitors. If larger players like Guardant or Foundation Medicine achieve similar sensitivity levels through their own R&D, BillionToOne's key differentiation could erode rapidly. The 51% higher mutation detection rate needs to remain meaningfully better than alternatives to justify premium pricing and drive adoption.

Prenatal market concentration: With 15% market share achieved rapidly, BillionToOne faces increasing resistance from dominant player Natera (60% share) who could leverage their scale and relationships to prevent further share gains. The "land and expand" strategy becomes harder as they target larger, more established practices that have long-term contracts with competitors.

Operational scaling challenges: The projected growth from $153M to $330M in two years while launching a new Austin facility requires precisely coordinated execution across sales, lab operations, and quality control. Any meaningful delays or quality issues could damage their reputation in both the prenatal and nascent oncology businesses, where physician trust is paramount.