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.
Media Contact: billiontoone@moxiegrouppr.com
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SOURCE BillionToOne