BillionToOne, Inc., a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, announces the launch of their UNITY fetal antigen single-gene non-invasive prenatal test (sgNIPT), a new addition to UNITY Screen™. For pregnant patients who are alloimmunized with C, c, D, E, Duffy (Fya), or Kell (K) red blood cell (RBC) antibodies, this novel NIPT looks for the presence of the genetic variants that code for the corresponding fetal antigens. UNITY fetal antigen NIPT is available at 10+ weeks gestation, and may streamline management for most pregnancies thought to be at risk for Hemolytic Disease of the Fetus and Newborn (HDFN), a rare but potentially deadly condition.
This novel fetal antigen NIPT may help streamline management of most alloimmunized pregnant patients.
Alloimmunization occurs in about 1% of pregnancies and is when the pregnant patient makes RBC antibodies as a result of foreign blood mixing. These antibodies can cross the placenta and attack the unborn baby. HDFN, the resulting condition, can have devastating effects on the fetus including anemia, hyperbilirubinemia, and death. Due to the potential severity of HDFN and the previous lack of non-invasive risk assessment tools, alloimmunized patients are typically monitored closely until delivery, sometimes via weekly blood titers and ultrasounds. This close monitoring determines if an early term delivery or an intrauterine transfusion may be indicated for the pregnancy.
The UNITY fetal antigen NIPT is available now for order by any provider managing pregnant patients who are alloimmunized.
BillionToOne, headquartered in Menlo Park, California, is a molecular diagnostics company with a mission to make molecular diagnostics more accurate, efficient, and accessible for all. The Company’s Quantitative Counting Templates™, QCTs, enable counting DNA molecules at the single-count level with single base-pair precision. BillionToOne was co-founded by Oguzhan Atay, Ph.D., and David Tsao, Ph.D. For more information, visit www.billiontoone.com.
1 Koelewijn JM, et al. Effect of screening for red cell antibodies, other than anti-D, to detect hemolytic disease of the fetus and newborn: a population study in the Netherlands. Transfusion. 2008 May; 48(5):941-52. doi: 10.1111/j.1537-2995.2007.01625.x. Epub 2008 Feb 1. PMID: 18248570.
2 Data on file. Analytical validation Sept 2022.
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