#USA #Menlo Park #Prenatal Testing #BillionToOne #Unity Confirm

BillionToOne Launches Unity Confirm™

BillionToOne, a leading innovator in molecular diagnostics, has recently unveiled its groundbreaking prenatal diagnostic test, Unity Confirm™. This revolutionary non-invasive test addresses a significant challenge in prenatal genetic testing—providing precise confirmation for high-risk screening results from a simple maternal blood draw.

For decades, scientists and clinicians have sought the ability to directly analyze intact fetal cells non-invasively to improve prenatal care. Traditional non-invasive prenatal testing (NIPT) has set a new standard in screening for fetal aneuploidies, but it leaves a critical gap: once a high-risk result is obtained, further invasive testing—like chorionic villus sampling (CVS) or amniocentesis—is recommended. However, these procedures carry risks and are often inaccessible to many patients, forcing some to forgo essential information about their pregnancy.

Unity Confirm™ is designed to bridge this gap by offering a non-invasive affirmation of high-risk NIPT results. Using its proprietary Fetal Cell Capture™ technology, BillionToOne isolates intact fetal cells from maternal blood, allowing for whole genome sequencing of these cells. This process provides comprehensive insights similar to those derived from invasive techniques, all without the associated risks. Dr. Oguzhan Atay, co-founder and CEO of BillionToOne, emphasizes that this test represents a monumental step forward: “Unity Confirm is proof that non-invasive confirmation is possible, allowing clinicians to provide accurate results that were previously only attainable through invasive means.”

With the technology validated in clinical studies demonstrating 100% concordance with fetal outcomes, Unity Confirm reflects a profound advancement in prenatal diagnostics. This development not only enhances the safety and comfort of expectant mothers but also expands access for those who may have previously felt restrained by risk or logistics. Dr. Haywood Brown, Chief Medical Officer of Prenatal at BillionToOne, states that “the real difference with Unity Confirm is its clinical accessibility. It's changing the standard of care for patients who face daunting decisions after a high-risk result.”

Unity Confirm will be available starting May 28, 2026, for patients who receive high-risk results under the UNITY Aneuploidy Screen. This initiative is poised to initiate the largest prospective study of a fetal cell-based confirmation assay to further substantiate the reliability and utility of the test. With a target enrollment of 1,000 participants, the study aims to evaluate the concordance of Unity Confirm with established invasive diagnostic procedures.

For more than two decades, the field of prenatal genetics has been pushing towards the non-invasive capture of fetal cells. The rarity of these cells in maternal circulation made achieving this goal a formidable challenge until now. Unity Confirm is not just an incremental step; it sets a new foundation in prenatal care, significantly improving the quality of life for expectant parents by delivering clarity amidst uncertainty.

As the medical community anticipates the unveiling of Unity Confirm at ACOG 2026 in Washington, D.C., the pathway forward appears promising for many families navigating the complexities of prenatal health. BillionToOne’s commitment to making accurate testing accessible to all shines as it redefines what is possible in prenatal diagnostics.