ACOG supports cfDNA testing as a reasonable alternative for fetal RBC testing among alloimmunized patients
MENLO PARK, Calif., July 26, 2024 /PRNewswire/ — BillionToOne, a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, is thrilled to announce a new publication that shows cfDNA analysis is highly sensitive and specific for determining fetal antigen genotype as early as 10 weeks gestation. The new study published online in Obstetrics and Gynecology, the official journal of the American College of Obstetricians and Gynecologists (ACOG), also known as “The Green Journal,” supports the implementation of cfDNA testing to manage alloimmunized pregnancies in the United States. This study follows the recent ACOG clinical practice update that supports cfDNA testing as a reasonable alternative to amniocentesis for fetal RBC testing among alloimmunized patients.
Hemolytic disease of the fetus or newborn (HDFN) is a potentially life-threatening form of anemia caused by alloimmunization. ACOG recommends testing the reproductive partner’s antigen status when alloimmunization is diagnosed in pregnancy. However, rates of reproductive partner screening uptake are low, and results can be misleading in the setting of nonpaternity.
In September 2022, BillionToOne’s UNITY Fetal Antigen NIPT became the first commercially available cfDNA test in the US, providing highly accurate assessments of the fetal status for RhD, c, C, E, K and Fya antigens. It is the only clinically available NIPT in the US that includes antigens beyond RhD and is offered as an add on to UNITY Complete, the first and only test that uses cell-free DNA to provide precise fetal insights for both recessive and chromosomal conditions.
The Green Journal study demonstrates the accuracy of an NGS-based cfDNA analysis assay using BillionToOne’s proprietary Quantitative Counting Templates™ (QCT™) for the detection of fetal red blood cell antigen status in a large, diverse U.S.-based cohort. With 100% accuracy and no need for paternal testing or invasive procedures, the study finds that this assay will result in more alloimmunized individuals receiving informative results about fetal risk when compared to the traditional approach.
“We commend ACOG for acknowledging the role of NIPT for fetal red blood cell antigen genotyping and are thrilled that this new study highlights the UNITY Fetal Antigen NIPT screen’s accuracy across all gestational ages and ethnicities, including complex maternal and fetal genotypes,” said Jennifer Hoskovec, Certified Genetic Counselor and Vice President of Medical Affairs at BillionToOne. “The implications of this ACOG update are significant for patients and providers alike, reducing the need for resource intensive pregnancy surveillance for fetal anemia for many patients.”
ACOG also recently announced that the use of RhD NIPT to conserve supply of Rh immunoglobulin (RhIg), also known as RhoGAM, is a reasonable consideration in the practice setting that is experiencing RhIg shortages. Since becoming available in 2020, BillionToOne’s Fetal RhD NIPT has served over 100,000 patients. The test offers a reliable and convenient alternative to traditional methods of determining fetal RhD status via cell-free DNA from maternal blood only as early as 9 weeks gestation.
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 all. The company’s patented Quantitative Counting Templates™ (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 www.billiontoone.com.
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