Letter from our Co-Founder & CEO
BillionToOne was born from a single question that continues to drive everything we do: What is the most challenging, most impactful global healthcare problem that physics allows us to solve, but that no one else will tackle?
As interdisciplinary scientists with PhDs, we were not interested in incremental improvements or well-trodden paths. My co-founder, David, and I wanted to confront problems of true consequence and provide solutions that could transform millions of lives. This pursuit led us to sickle cell disease and beta-thalassemia. These are the most common genetic disorders worldwide and classified by the World Health Organization as among the greatest global healthcare burdens.
Prenatal detection of these conditions required us to develop a novel technology capable of reaching the physical limit of detection and precision. However, this challenge did not stop us. In fact, it invigorated our resolve to create solutions for these burdensome genetic conditions.
We knew that if we developed such a technology, we would unlock the full potential of cell-free DNA, the most remarkable biomarker that represents every tissue in blood. It was only through our interdisciplinary approach that combines physics, applied mathematics, and molecular biology that we have been able to invent a breakthrough technology that could tackle this problem.
Since then, our diagnostics innovations have already changed the diagnostics paradigm in multiple areas. Just from a single maternal blood sample, our prenatal tests detect whether a developing baby is at risk for many severe but actionable diseases, early on during pregnancy. Our oncology tests first detect the most important features of a tumor that determine the best course of therapy for that patient from a blood draw. They then enable the physicians to know precisely how well the therapy is working, and when it stops working, often many months ahead of imaging scans.
While we have state-of-the-art laboratories today, we have never forgotten that we started with half a bench at a Stanford University accelerator space. It was more difficult to raise the initial $300,000 than the $300,000,000 that followed it. Our name, BillionToOne, reflects our technological breakthrough as we believe it is the only platform that can detect a single DNA letter of a single DNA molecule among the three billion other letters in our genome. But, it also reflects our founding spirit. The domain was simply the only relevant one that we could acquire for just $12. And we refused to spend more for a name at that stage.
This decision is an example of a set of principles that have guided our growth to becoming a pioneer in precision diagnostics. These principles are not only management’s philosophy. They are the operating system of our company and foundation of our success.
Our Guiding Principles
Relentless resourcefulness. In our earliest days, we traveled to Turkey to collect the first specimens from pregnant patients and to India, where beta-thalassemia is much more common, to conduct our first clinical studies. It was an unnerving process every time we cleared customs with our reagents, knowing that each sample we can test represented not just data points, but a crucial step toward helping real families facing devastating genetic conditions. This was not just about frugality. This and many similar examples of resourcefulness ended up significantly accelerating our progress.
Patients first. The weight of what we do has been clear to us from the very early days when we started receiving tests not just for general screening, but from high-risk pregnant mothers who already had previous babies with these severe conditions and wanted to rely on us to avoid amniocentesis. In fact, our first-ever clinical test was for SMA, a devastatingly progressive condition in which every day matters for treatment efficacy. I vividly remember doing a custom report design with David until 2 a.m. to best represent our result. While we have automated almost all analysis and reporting over time, we maintain this personal touch to this day. Our genetic counselors, scientists, and laboratory directors, and sometimes still I, personally look at individual patient data when needed.
Audacious goals. We set targets that initially seem impossible. In 2020, we set a small set of ambitious goals that we wanted to achieve by 2025. These goals ranged from changing medical guidelines to processing one million molecular diagnostic tests. At the time, we were in a tiny lab and even tinier office. Our daily test volume was approximately five tests per day, and our small team would ‘high five’ each time we were notified with a ping indicating a sample was picked up. Even our executive team thought our 5-year goals bordered on fantasy. However, each sample represented a patient receiving insights that could change the course of their healthcare journey, invigorating us to push harder. By March 2025, we conducted our millionth test and achieved every one of our seemingly impossible 2025 goals, by breaking them down into quarterly milestones and executing with precision.
Disciplined and focused. Achieving such audacious goals has only been possible because we have been ruthless in saying “No” to any and all distractions. We did not get distracted by early-stage M&A discussions, investment outreaches outside of fundraising periods, seemingly lucrative partnerships, and me-too product expansions that could generate significant additional revenue. Anything that was outside the scope of our 5-year goals was not worked on.
Pressure is a privilege. Our executive team adopts the motto, “pressure is a privilege.” If you are asked to deliver stretch goals, the implication is that we trust in your abilities to get the job done. We have found this trust to be well placed. Every time our executives are asked to deliver on ambitious goals, they see it as a badge of trust. And every time they run into a problem, they see it as an opportunity. When COVID-19 resulted in Ob/Gyn clinics restricting access to sales reps threatening our survival, we did not retreat. At a time that the US government had limited N95 masks, we were able to find and import them, preserving our ability to have safe conversations with the Ob/Gyns. We grew our test volume more than 10x during 2020, surpassing every quarterly goal that we had set before COVID-19. More recently, when we set a goal to decrease our COGS by approximately ~20% in a single year, instead of remarking on the difficulty of the goal, we broke it down to pieces, worked together as a team, and not only achieved but surpassed this challenging goal. This mindset has become one of our core strengths.
Step-by-step deliberate approach. While we believe others in our industry poured hundreds of millions of dollars into fully automated labs that locked down their assays, we identified bottlenecks systematically, automating our facilities step-by-step. This deliberate progression has allowed us to remain nimble and build a proprietary and scalable laboratory infrastructure while continuously improving our products. It also provided us with the financial discipline that has become a competitive advantage.
20-Mile March. We embrace what Jim Collins calls the "20-Mile March" philosophy. We play the long game with fanatical discipline and relentless execution regardless of external conditions. We do not overextend in good times or retreat in challenging ones. When the markets were rewarding growth at all costs, we prioritized sustainable growth over flashy but hollow and expensive expansion. Even during the darkest days of market volatility, we maintained our pace of growth, continuing to hire and grow past our competitors. This approach has enabled us to achieve in the first half of 2025 what many thought impossible: growing our revenue by 82% year-over-year while achieving positive non-GAAP net operating income — a feat almost unheard of in molecular diagnostics.
1%’ers. Our hiring process is so rigorous that we select only 1% of all applicants. But this is not just about hiring the smartest or most talented people. This is about creating a collaborative culture that pushes the limits of what each individual could achieve on their own. This is about building a team that is empowered and capable of solving problems that have stumped the entire industry for decades. This is the philosophy of ONE. Walking through our labs and offices, you can feel the difference. Challenges are met not with complaints but with creative solutions. People move with purpose. This is not just another healthcare company; it is a gathering of minds determined to rewrite what is possible in molecular diagnostics.
We believe that these guiding principles enabled us to achieve a unique profile that combines powerful technology, category-defining products, and a differentiated financial position of 84% year-over-year growth and emerging profitability. We believe that these elements will make BillionToOne a generational company that can redefine the industry and achieve our goal of becoming the first molecular diagnostics company in the S&P 500.
The Opportunity & Long-Term Vision
The precision diagnostics market represents one of the greatest opportunities in healthcare today. As our understanding of the disease processes deepens, the ability to deliver precise, actionable information to clinicians becomes increasingly valuable. Our technology platform enables us to unlock this information and gives us an advantage to succeed in multiple high-growth markets, with our current products addressing a more than $20 billion total addressable market (TAM), while our planned pipeline of products in development can increase this to over $100 billion.
These numbers only hint at our true opportunity. The true opportunity is to not only change the standard of care for diagnostics but also enable new treatment paradigms. We are already seeing this. Our partnership with Johnson & Johnson has the potential to enable a therapy for hemolytic disease in fetuses and newborns, a high-risk condition that can result in fetal death. We are hearing more and more about pregnant mothers taking CF therapies for their affected babies during pregnancy, and their CF newborns not needing NICU stays or sometimes even passing newborn screening, an incredible outcome. Our goal is to make such success stories standard-of-care in the next five years.
Our next five-year goals for 2030 are much more ambitious and, in some instances, more than 10 times higher than 2025 goals we have already achieved. Yet, this time, our current investors who have witnessed our journey and executives on our team firmly believe they are achievable. They believe because they have seen our track record and know what is possible when a unique combination of talent, culture, and technology converges on a mission that matters.I personally believe that when we look back a decade from now, we will see that the largest impact on pregnancy and cancer care of the past 100 years will have come from BillionToOne, powered by our technology and our people. That belief is what drives us. That is why we work tirelessly.
Why Go Public Now
This offering represents a pivotal moment in our journey. The capital we raise will accelerate our research and development initiatives, expand our commercial footprint, and enable us to bring our life-changing diagnostics to more patients.
But this offering is about more than capital. It is about setting the stage for our next phase of growth and impact. It is about building the foundation for a company that will stand among the most consequential healthcare innovators of our time.
We are not building just another successful company; we are changing the very landscape of healthcare. Millions of patients whose lives will be transformed may never know our name, but they will benefit from what we have built.
We invite you to join us in writing this next chapter of medical history.
Sincerely,
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Oguzhan Atay, PhD
Co-Founder & CEO
