MENLO PARK, Calif., March 10, 2020 /PRNewswire/ --BillionToOne, Inc., the precision diagnostics company that invented the patent-pending QCT molecular counter platform, announced today that it has closed its follow-on Series A+ funding round of$15 millionwith select global investors. Previous investors, Hummingbird Ventures and NeoTribe Ventures led the investment round with participation from Y Combinator, Libertus Capital, Pacific 8 Ventures, Civilization Ventures, 500 Startups Istanbul, and HOF Capital. This brings the total funding that BillionToOne has raised to more than $32.5 million. The funding will be used to support 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.

"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," said Oguzhan Atay, Ph.D., co-founder and CEO of BillionToOne. "This additional funding will help us accelerate this expansion process."

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. Similarly, in today's liquid biopsy tests, certain cancer mutations, such asHER2, one of the most important genes for breast cancer, may need to be as high as 20 percent of the total cell-free DNA of a blood sample to be detected. BillionToOne's platform can quantitatively measure and determine these mutations at much lower levels.

"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," saidFirat IleriofEurope-based Hummingbird Ventures. "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."

Cell-free DNA testing is the fastest growing diagnostic sector in history. It 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 such as cystic fibrosis, spinal muscular atrophy (SMA), and hemoglobinopathies from a single tube of blood from the pregnant mother. With all 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. The need to test the father poses a significant challenge to many clinics to follow through for financial and logistical reasons, such as unavailability of Medicaid for paternal testing, availability of the father, non-paternity, and other logistical challenges. According to a 2019 publication by UTHealth Genetic Counseling group[1], 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%."

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[2]. By eliminating the need for father's testing and directly assessing the baby's risk, UNITY increases the detection rate of at-risk babies from <41.5% to as high as 98.5%, thus significantly improving the clinical outcomes[3].

UNITY is available for commercial order in all US States except for New York State, as well as globally in select international countries. For more information visit unityscreen.com.

CONTACTS:

Oscar Cabot, Head of Marketing ocabot@billiotoone.com

Shan Riku, VP of Product, sriku@billiontoone.com

About BillionToOne

BillionToOne, headquartered in Menlo Park, California, is a precision diagnostics company with a mission to make molecular diagnostics more accurate, efficient, and accessible for all. The company's patent-pending QCT molecular counter platform is the only technology platform that can accurately count DNA molecules to the single-count level. 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. For more information, visit http://www.billiontoone.com or http://www.unityscreen.com.

[1] Choates et.al., "It takes two: uptake of carrier screening among male reproductive partners" Prenatal Diagnosis, 2019; 1-6

[2] ACOG Committee Opinion Number 691, March 2017 (reaffirmed 2019)

[3] Tsaoet.al., "A novel high-throughput molecular counting method with single base-pair resolution enables accurate single-gene NIPT" Scientific Reports 9, 14382 (2019)

[4]Westinet.al., "Clinical validity of single-gene non-invasive prenatal testing for sickle cell disease and beta-thalassemia." (manuscript in preparation)

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