BillionToOne Announces Global Collaboration to Provide its UNITY Fetal Antigen™ Clinical Trial Assay in Johnson & Johnson Phase 3 Clinical Trial of Nipocalimab in Hemolytic Disease of the Fetus and Newborn
MENLO PARK, Calif., Dec. 12, 2023 /PRNewswire/ -- BillionToOne (BTO), a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, is pleased to announce a global collaboration with Janssen Research & Development, LLC, a Johnson & Johnson company (Johnson & Johnson), in the AZALEA Phase 3 clinical trial of nipocalimab in pregnancies at risk for severe hemolytic disease of the fetus and newborn (HDFN). BTO will provide its UNITY Fetal Antigen Non-invasive Prenatal Test Clinical Trial Assay (UNITY Fetal Antigen CTA), which will serve as a screening assay to help determine the eligibility of pregnant individuals to be included in the trial, which will be conducted in the United States, the European Union, and other select countries in the rest of the world. HDFN is a serious and rare condition which occurs when the blood types of a pregnant individual and the fetus are incompatible, potentially causing life-threatening anemia in the fetus or infant.1
- "The ability to detect fetal antigens as early as 10 weeks is only made possible due to our expertise in fetal DNA quantification.
- The UNITY Fetal Antigen CTA is just one of the many applications of our QCT technology's capabilities."
- Earlier this year, BillionToOne also published clinical validation data of the UNITY Fetal Antigen Laboratory Developed Test (LDT)2.
- Additionally, the UNITY Fetal Antigen LDT results were 100% concordant with corresponding neonatal antigen genotype/serology for 23 RhD-negative pregnant individuals and 93 antigen evaluations in 30 alloimmunized pregnancies.2