BillionToOne has launched an expanded Red Blood Cell Fetal Antigen NIPT and a new Platelet Fetal Antigen NIPT, both available through the company’s UNITY Aneuploidy Screen. The company says these are the first non-invasive prenatal tests in the United States designed to determine fetal antigen status across both red blood cell and platelet antigens.
The tests address Hemolytic Disease of the Fetus and Newborn (HDFN) and Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT), conditions that together affect or place at risk approximately 1.5-2.5% of pregnancies in the US – a rate higher than the genetic burden of aneuploidies.
The expanded RBC test now covers approximately 99% of antigens associated with HDFN. BillionToOne’s peer-reviewed studies have demonstrated greater than 99.9% sensitivity and specificity and 100% concordance with neonatal outcomes.
“We have a proven track record of building tests that close gaps in care and improve clinical decision-making,” said Dr. Oguzhan Atay, Co-Founder and CEO of BillionToOne. “By expanding fetal antigen coverage for HDFN to encompass nearly all clinically relevant antigens, we are delivering more comprehensive and definitive answers earlier in pregnancy. We are also applying the same approach to platelet antigen incompatibility in a first-of-its-kind offering.”
The Platelet Fetal Antigen NIPT addresses FNAIT, a condition associated with severe neonatal thrombocytopenia and intracranial hemorrhage. BillionToOne says routine antibody screening for platelet antigen incompatibility is currently unavailable despite severe cases leading to intracranial hemorrhage in the fetus.
