Molecular diagnostics company BillionToOne has launched an enhanced version of its UNITY Fetal Risk Screen, now capable of assessing the risk of up to 14 genetic conditions from a single maternal blood sample. This expanded screening can be conducted as early as nine weeks into pregnancy.
The latest panel includes the five conditions recommended for universal screening by the American College of Obstetricians and Gynecologists (ACOG), alongside nine additional actionable genetic conditions, which are more common in specific populations.
Dr. Aabeen Hagroo, an obstetrician-gynaecologist at Trinity Health IHA Medical Group, explained, “The ability to screen for a more comprehensive range of conditions at just nine weeks gestation represents a paradigm shift in prenatal care. The expanded 14-gene offering allows us to identify potential health challenges months before conventional testing methods. For conditions where early intervention is crucial, this additional time can be transformative – allowing families to connect with specialists, coordinate care plans, and access treatments that could significantly improve their child’s health outcomes.”
The UNITY Fetal Risk Screen employs BillionToOne’s patented Quantitative Counting Template (QCT) technology, which analyses both the maternal carrier status and fetal cell-free DNA using just one blood sample. This technology offers a more accurate fetal risk assessment, with risk values ranging from as low as 1 in 5,000 to as high as 9 in 10, rather than the generalised 1 in 4 risk seen with conventional carrier screenings.
Notably, the test is designed to detect both recessive and X-linked genetic conditions without requiring a partner’s genetic sample. This makes the process simpler and provides quicker access to crucial information, supporting better pregnancy management decisions.
Oguzhan Atay, Ph.D., Co-founder and CEO of BillionToOne, stated, “At BillionToOne, we are committed to pushing the boundaries of molecular diagnostics and improving prenatal care. By expanding our products to include a 14-gene offering that includes these prevalent and actionable conditions, we’re providing healthcare providers and expectant parents with vital information that can significantly impact pregnancy management and long-term health outcomes.”
The company will continue to offer its original 5-gene panel, with the expanded 14-gene option providing healthcare professionals and parents with greater insight, enabling early intervention through gene therapies, specialised care, and dietary adjustments.
