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The UNITY Fetal Antigen Clinical Trial Assay has received Investigational Device Exemption (IDE) as part of this initiative 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 "We are extremely proud to play a critical role in this clinical trial with the UNITY Fetal Antigen CTA test" said Oguzhan Atay, PhD, CEO of BillionToOne. "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." In April 2023 U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE), to enable the UNITY Fetal Antigen CTA to be used in this trial, an important milestone to support the start of the Phase 3 AZALEA study of nipocalimab in HDFN in the U.S. BillionToOne will also seek regulatory clearance by health authorities around the world for the UNITY Fetal Antigen CTA. The UNITY Fetal Antigen CTA is a next-generation sequencing (NGS) non-invasive prenatal test intended for the qualitative detection of cell-free fetal DNA (cffDNA) encoding for fetal antigens RhD, RhC, Rhc, RhE, or Kell (K) in the blood of pregnant adults who are alloimmunized against the corresponding fetal red blood cell (RBC) antigen and at risk of HDFN. Earlier this year, BillionToOne also published clinical validation data of the UNITY Fetal Antigen Laboratory Developed Test (LDT)2. In this validation study, the UNITY Fetal Antigen LDT correctly determined the antigen status for 1,061 preclinical samples resulting in >99.9% concordance and a sensitivity and specificity of >99.9% (95% CI: 99-100%). 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 About Hemolytic Disease of the Fetus and Newborn (HDFN) HDFN is a serious condition that occurs when a pregnant patient's antibodies cross the placenta and attack the fetal red blood cells.1 When most severe, HDFN can cause life-threatening anemia in the fetus.3 There are currently no approved non-surgical interventions for pregnancies at high risk of HDFN.4 Pregnancies affected by severe HDFN may necessitate repeated intrauterine transfusions (IUTs), an invasive, technically complex surgical procedures performed by specialists at specialized medical centers, and these procedures may be associated with an increased rate of fetal mortality and premature births.4,5,6 About the UNITY Fetal Antigen CTA The UNITY Fetal Antigen CTA was developed to support the AZALEA study in the phase 3 clinical trial of nipocalimab in HDFN. In April 2023 U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE), to enable the UNITY Fetal Antigen CTA to be used in this trial. The UNITY Fetal Antigen CTA is a next-generation sequencing (NGS) non-invasive prenatal test intended for the qualitative detection of cell-free fetal DNA (cffDNA) encoding for fetal antigens RhD, RhC, Rhc, RhE, or Kell (K) in the blood of pregnant adults who are alloimmunized against the corresponding fetal red blood cell (RBC) antigen and at risk of HDFN. The UNITY Fetal Antigen CTA has not been cleared by the FDA for commercial use. About the UNITY Fetal Antigen LDT UNITY Fetal Antigen LDT was first made available in September 2022 for pregnant patients alloimmunized against RhD, C, c, E, K (Kell), and Fya (Duffy) red blood cell (RBC) antigens. Using BillionToOne's proprietary molecular counting technology or Quantitative Counting Templates™, this NGS-based assay detects the presence or absence of the genetic variants that code for corresponding fetal antigens to accurately identify which patients are truly at highest risk for developing HDFN. Since the test was made available, more than 1,300 UNITY Fetal Antigen NIPTs have been ordered in a commercial setting. About 60% of those patients received a "Not Detected" Fetal Antigen result, potentially sparing the expecting families from follow-ups and undue anxiety2. The UNITY Fetal Antigen LDT is available for clinical use through BillionToOne's CLIA-certified and CAP-accredited clinical laboratory. About BillionToOne Headquartered in Menlo Park, California, BillionToOne is a precision diagnostics company on a mission to make molecular diagnostics more accurate, efficient, and accessible for everyone. The company's patented Quantitative Counting Technology™ (QCT™) molecular counting platform is the only multiplex technology that can accurately count DNA molecules at the single-molecule level. For more information, please visit For more information about the trial or the collaboration, please contact [[email protected]] SOURCE BillionToOne