A new noninvasive prenatal test designed to determine fetal platelet antigen status may expand options for identifying pregnancies at risk for fetal and neonatal alloimmune thrombocytopenia (FNAIT), according to a press release from BillionToOne, a molecular diagnostics company based in California.
The newly launched test, available through the company’s UNITY screening platform, analyzes cell-free DNA (cfDNA) in maternal blood to determine whether a fetus carries specific human platelet antigens that could trigger a maternal immune response.
The company stated the test is intended to help clinicians assess risk of FNAIT by determining whether a fetus carries a platelet antigen that could be targeted by maternal antibodies. Unlike traditional approaches that may rely on paternal testing or invasive diagnostic procedures, the cfDNA-based test aims to provide fetal antigen information through a blood draw during pregnancy.
Currently, routine screening for platelet antigen incompatibility is not widely performed in the United States. Diagnosis is often made following unexpected complications at birth or a prior pregnancy complication. By offering direct fetal antigen genotyping noninvasively, the new test may assist with earlier risk stratification to help clinicians determine which pregnancies require closer monitoring or treatment.
Learn more about FNAIT testing and diagnosis
The company also announced an expanded red blood cell antigen test to assess risk for hemolytic disease of the fetus and newborn (HDFN), another antibody-mediated condition. This test increases the range of detectable antigens to cover what the company says is approximately 99% of antigens linked to the condition, based on peer-reviewed data.
Together, FNAIT and HDFN are estimated to affect between about 1.5% and 2.5% of pregnancies in the United States.
“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,” Oguzhan Atay, PhD, Co-Founder and CEO of BillionToOne, said in the press release. “We are also applying the same approach to platelet antigen incompatibility in a first-of-its-kind offering. Together, the expanded UNITY RBC Fetal Antigen NIPT and Platelet Fetal Antigen NIPT provide clarity for pregnant patients who need it the most, with no additional blood draw.”
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