Precision diagnostics startup BillionToOne raises $125M for the world’s first genetic testing platform that detects disease at the molecular level

Early diagnosis and detection of diseases before they evolve and take up shape is are critical saving millions of lives every year. In recent years, progress has been made in using computers and machine learning to enhance traditional diagnosis, but more research is still needed. Now, one startup is taking a completely different approach to disease detection.

Enter BillionToOne, a Silicon Valley-based molecular diagnostics startup company on a mission to make molecular diagnostics more accessible for all. To date, BillionToOne is the only genetic testing platform that accurately and efficiently detects and measures disease at the molecular level. By counting single molecules of DNA, BillionToOne is able to create diagnostics that reduce uncertainty and give clinicians and patients the clarity to make effective and confident medical decisions.

Today, BillionToOne announced it has closed $125 million led by some of the world’s premier investors. The startup will use the fresh capital infusion to expand its commercial and clinical teams, scale-up lab capacity, and conduct clinical studies for its liquid biopsy test.

The round was co-led by new investor Adams Street Partners and existing investor Hummingbird Ventures. Other backers include Baillie Gifford, Neotribe Ventures, Norwest Venture Partners, Civilization Ventures, Fifty Years VC, Pacific 8 Ventures, Time BioVentures, and Libertus Capital, among others.

Founded in 2016 by CEO Oguzhan Atay (Ph.D.), David Tsao, and Sukrit Silas, BillionToOne is a precision diagnostics startup company that quantifies biology to create molecular diagnostics accurate, efficient, and accessible for all. The company’s patent-pending molecular counter platform is a technology platform that can accurately count the DNA molecules to the single-count level. The Company’s QCT molecular counter platform is the only technology that can count DNA molecules at the single-count level with single base-pair precision.

In a statement, BillionToOne Co-founder and CEO Oguzhan Atay, Ph.D. said, “Our prenatal test is solving a critical unmet medical need. We continue to grow at an incredible rate, and we are building out an ever-increasing set of larger laboratory facilities. The current funding will be used to support our prenatal test growth while launching our differentiated liquid biopsy test that will transform oncology care.”

BillionToOne’s molecular counting technology increases the resolution of disease detection using cell-free DNA by over 1000-fold. This technology is at the core of the Company’s products. BillionToOne’s flagship product, UNITY Screen™, is the only non-invasive prenatal test (NIPT) that can assess fetal risk for common recessive conditions and aneuploidies from one maternal blood sample.

According to an independent peer-reviewed publication (Choates et al., 2020), less than half of male partners go through traditional carrier screening when indicated, limiting the identification of at-risk pregnancies. UNITY Screen™ does not require a paternal sample to assess fetal risk, supporting greater equity in care. The Company has been growing its market share at an exponential pace, with test volumes increasing more than 300% year over year in the fiscal year 2021. BillionToOne is applying this same molecular counting technology to a groundbreaking liquid biopsy test that combines treatment selection with monitoring. This test is slated to launch this year.

“We have partnered with BillionToOne since their Series A in 2019, and it has been incredible to witness the Company’s tremendous growth and unparalleled execution. BillionToOne has experienced a significant expansion in terms of test volume and team members despite a pandemic. This is not by accident. The Company has an extremely talented and diverse team and a powerful technology platform. This unique combination will lead BillionToOne to revolutionize molecular diagnostics,” said Firat Ileri at Hummingbird Ventures, a board member and one of the lead investors at BillionToOne.

Thomas Bremner from Adams Street Partners, who is joining BillionToOne’s Board of Directors, adds, “BillionToOne’s truly differentiated technology, product lines that enable it to grow with higher efficiency, execution in the prenatal market, and plans for the oncology sector are exactly the kinds of traits we look for in companies that we invest in. We have great confidence around their growth trajectory and look forward to the next phase as they build a category-defining molecular diagnostics company.”