NEW YORK – BillionToOne announced on Tuesday that it would provide its cell-free fetal DNA assay to screen patients for eligibility for Johnson & Johnson's Phase III AZALEA trial of nipocalimab in pregnancies at risk for severe hemolytic disease of the fetus and newborn (HDFN).
HDFN is a rare condition in which the blood types of a pregnant woman and her fetus are incompatible. Maternal antibodies in this situation can cross the placenta and attack fetal red blood cells, potentially triggering life-threatening anemia in the fetus or infant.
BillionToOne's UNITY Fetal Antigen Non-invasive Prenatal Test Clinical Trial Assay (UNITY Fetal Antigen CTA) is a noninvasive, prenatal next-generation sequencing test used to detect cell-free fetal DNA encoding fetal antigens RhD, RhC, Rhc, RhE, Kell (K), or Fya (Duffy) in the blood of pregnant adults whose antibodies could react against them.
BillionToOne developed the UNITY Fetal Antigen CTA to support Johnson & Johnson's AZALEA trial, and the US Food and Drug Administration approved an investigational device exemption for it in April, enabling its use in the trial. The trial will take place in the US, EU, and select other countries.
The randomized, placebo-controlled trial aims to enroll roughly 120 individuals whose pregnancies are at risk of HDFN to evaluate the safety and efficacy of nipocalimab in decreasing the risk of fetal anemia.
"The ability to detect fetal antigens as early as 10 weeks is only made possible due to our expertise in fetal DNA quantification," BillionToOne CEO Oguzhan Atay said in a statement. "The UNITY Fetal Antigen CTA is just one of the many applications of our [Quantitative Counting Templates (QCT)] technology's capabilities."
Earlier this year, BillionToOne published a study clinically validating the UNITY Fetal Antigen Laboratory Developed Test, which was made available in September 2022 to test patients for antibodies against RhD, C, c, E, K, and Fya (Duffy) antigens. The NGS-based test uses BillionToOne's QCT technology to identify patients at high risk for developing HDFN.
The Menlo Park, California-based company believes that its molecular counting technology can be applied to both prenatal screening and to oncology, where it might offer improved sensitivity for advanced cancer genotyping and longitudinal therapy response monitoring.