Molecular diagnostics company BillionToOne has launched an expanded version of its UNITY Fetal Risk Screen that can assess fetal risk for up to 14 genetic conditions from a single maternal blood sample as early as nine weeks into pregnancy.
The expanded panel includes the five conditions recommended by the American College of Obstetricians and Gynecologists (ACOG) for universal screening, plus nine additional actionable conditions commonly found in certain populations.
“The ability to screen for a more comprehensive range of conditions at just nine weeks gestation represents a paradigm shift in prenatal care,” said Dr. Aabeen Hagroo, an obstetrician-gynecologist at Trinity Health IHA Medical Group. “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 uses patented Quantitative Counting Template (QCT) technology to analyze both maternal carrier status and fetal cell-free DNA from a single blood sample. Unlike traditional carrier screenings that provide generic reproductive risks of up to 1 in 4, the test delivers a precise fetal risk assessment that can range from as low as 1 in 5000 to as high as 9 in 10.
The expanded panel screens for recessive and X-linked conditions without requiring a partner sample, which the company states simplifies the testing process and provides more timely information for pregnancy management decisions.
“At BillionToOne, we are committed to pushing the boundaries of molecular diagnostics and improving prenatal care,” said Oguzhan Atay, Ph.D., Co-founder and CEO of BillionToOne. “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 highlights several key advantages of the expanded panel, including earlier detection of genetic conditions, precise pregnancy-specific risk assessment, and timely information for early intervention planning, such as access to gene therapies, dietary modifications, and specialized care.
BillionToOne continues to offer its original 5-gene panel alongside the new 14-gene offering. The company’s technology reportedly represents an advancement beyond the detection capabilities used for aneuploidies and microdeletions, enabling accurate assessment of recessive genetic conditions.
