MENLO PARK, Calif., Sept. 30, 2022 /PRNewswire/ -- 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.
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 report will show if the fetal antigen of interest is detected or not detected, providing stronger clinical conviction for those patients who require rigorous monitoring. Importantly, it is expected that up to 65%1 alloimmunized pregnant patients will not be carrying fetuses that express the antigen(s) of interest. This may drastically minimize unnecessary healthcare resources, decrease monitoring visits, and, most importantly, reduce unnecessary anxiety for many families. Analytical validation data show the test sensitivity and specificity is >99.9%2. A manuscript is currently being submitted for peer-review and is expected to be available before the end of the year.
"This new test is such a welcome offering for providers to help streamline management and focus monitoring on those patients who need it most, while reducing the emotional and logistical burden on those at low risk," said Dr. Kenneth J. Moise, a board certified Maternal Fetal Medicine Specialist, Director of the Comprehensive Fetal Care Center, and Professor of Women's Health at Dell Medical School at the University of Texas, Austin. Oguzhan Atay, BillionToOne CEO, added, "We are thrilled to launch our UNITY fetal antigen sgNIPT. While HDFN only affects 1% of US pregnancies, it can have dire consequences, and the extra, and often unnecessary, monitoring can be a significant source of anxiety for patients. This is yet another example of our powerful Quantitative Counting Templates (QCT) technology and its application to single-gene NIPT fulfilling a previously unmet medical need. Providing up to 65% of alloimmunized patients with greater peace of mind that their babies are low risk is the type of patient-oriented product we always strive for."
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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