BillionToOne To Expand UNITY Prenatal Screen With New Funding Round

By Annie Baker ● March 16, 2020
  • Precision diagnostics company BillionToOne announced it raised $15 million in Series A+ funding

BillionToOne, a precision diagnostics company that invented the patent-pending QCTTM molecular counter platform, announced recently that it closed a follow-on Series A+ funding round of $15 million with select global investors. Previous investors Hummingbird Ventures and NeoTribe Ventures led the funding round with participation from Y Combinator, Libertus Capital, Pacific 8 Ventures, Civilization Ventures, 500 Startups Istanbul, and HOF Capital. Including this round of funding, BillionToOne has raised over $32.5 million.

BillionToOne’s patent-pending QCT molecular counter platform is known as the only technology platform that can accurately count DNA molecules to the single-count level. And BillionToOne’ s first product, UNITY is the first and only noninvasive prenatal screening that tests fetal cell-free DNA for cystic fibrosis (CF) and spinal muscular atrophy (SMA) through a single sample of the mother’s blood. BillionToOne was co-founded by Oguzhan Atay Ph.D. and David Tsao, Ph.D.

This round of funding will be used for supporting the commercial expansion of UNITY to all US states as well as the research and development (R&D) of future diagnostics tests including liquid biopsy products.

The current non-invasive prenatal tests (NIPTs) exclude single-gene inherited disorders like cystic fibrosis and spinal muscular atrophy because they can only detect large chromosomal abnormalities greater than one million base-pairs. And with the current liquid biopsy tests, certain cancer mutations like HER2 (one of the most important genes for breast cancer) may need to be as high as 20% of the total cell-free DNA of a blood sample to be detected. What BillionToOne’s platform can do is quantitatively measure and determine these mutations at much lower levels.

Cell-free DNA testing — which is the fastest growing diagnostic sector in history — is currently used in several health care settings, including prenatal genetic testing for chromosomal abnormalities and oncology for blood-based tumor profiling in late-stage cancers.

BillionToOne’s first product UNITY is the first and only prenatal screen that directly assesses the baby’s risk for common and severe inherited disorders like cystic fibrosis, spinal muscular atrophy (SMA), and hemoglobinopathies from a single tube of blood from the pregnant mother. With other existing carrier screening tests, both mother and father have to be tested for their carrier status to assess the baby’s risk for these conditions.

But the need to test the father poses a significant challenge to many clinics to follow through for financial and logistical reasons like unavailability of Medicaid for paternal testing, availability of the father, non-paternity, and other logistical challenges.

According to the 2019 publication by the UTHealth Genetic Counseling group,  only 41.5% of male partners could be tested for carrier status when mothers were found to be carriers. This means the detection rate (i.e. sensitivity) of at-risk babies through the current screening workflow is at most 41.5%.”

The screening for cystic fibrosis, spinal muscular atrophy, and hemoglobinopathies is recommended by The American College of Obstetricians and Gynecologists (ACOG) to be offered to all women considering pregnancy or currently pregnant. And by eliminating the need for the testing of the father and directly assessing the baby’s risk, UNITY increases the detection rate of at-risk babies from less than 41.5% to as high as 98.5%. This significantly improves clinical outcomes.

UNITY is now available for commercial order in all US states except for New York State as well as globally in select international countries.

Key Quotes:

“Since the launch of UNITY last summer, we faced a significant demand from the prenatal providers from community Ob/Gyns to top academic institutions throughout the US. We are planning to expand the capacity of our CLIA-licensed laboratory by more than 20x and our commercial team size up to 50 account executives to meet the demand. This additional funding will help us accelerate this expansion process.”

-Oguzhan Atay, Ph.D., co-founder and CEO of BillionToOne

“We are delighted with the surging demand in the market for UNITY. With additional novel clinical products in the pipeline, we are more confident than ever for the future growth of BillionToOne. We continue to believe that BillionToOne’s sequencing platform is the future of cell-free DNA-based molecular testing.” Kittu Kolluri, ex-NEA general partner and the current managing director at Neotribe Ventures, added, “BillionToOne’s ability to execute on both R&D and commercial growth has been remarkable. We are pleased to continue to support this growth.”

-Firat Ileri of Hummingbird Ventures