Groundbreaking Genetic Screening Test Has
Helped Over 80,000 Pregnant Patients Determine Need for Anti-D
Immune Globulin
MENLO PARK, Calif.,
April 17,
2024 /PRNewswire/ -- BillionToOne, a molecular
diagnostics company with a mission to create powerful and accurate
tests that are accessible to all, has reached a milestone of
testing over 80,000 patients for Rh incompatibility, which develops
when a pregnant patient has Rh-negative blood and the baby has
Rh-positive blood. In rare cases this incompatibility can lead to a
serious issue in which the pregnant patient's immune system will
attack their baby's red blood cells as foreign.
Currently, the protocol for managing this potential
incompatibility for the 15% of pregnant patients who are
Rh-negative is the administration of Anti-D Immune Globulin, an
extremely effective intervention that significantly improved
maternal and fetal care in the 20th century. However, the FDA
recently announced that the most common brand of this medication,
RhoGAM(R), is in shortage. While this treatment is necessary to
prevent complications, it is only necessary if the baby's blood is
Rh-positive. As a result, Anti-D Immune Globulin treatment is
unnecessary for the 40% of pregnancies where the baby is
Rh-negative.
"Healthcare providers and blood banks across the U.S. are facing
a unique challenge because of the RhoGAM(R) shortage, and it's
important now that the healthcare industry works together to
support the treatment of Rh sensitization and its implications.
Utilizing cell-free DNA in maternal plasma, the UNITY Fetal RhD
Non-Invasive Prenatal Test can determine fetal RhD status," said
Jennifer Hoskovec, MS, Certified
Genetic Counselor and Senior Director of Medical Affairs at
BillionToOne. "We are grateful to have the opportunity to
support patients in avoiding unnecessary treatments during their
pregnancies and to save the reduced supply of RhoGAM(R) for the
pregnant people who truly need it to safely address and treat
differing Rh status."
The UNITY Fetal RhD NIPT offers a reliable and convenient
alternative to traditional methods of determining fetal RhD status,
such as paternal testing and invasive procedures like
amniocentesis. The UNITY Fetal RhD NIPT accurately determines the
RhD status of the fetus from maternal blood as early as 10 weeks
gestation. Recent data published in Scientific Reports
demonstrated that the test has diagnostic-level accuracy with
>99.9% sensitivity and specificity, and 100% concordance with
newborn outcomes, including for the detection of RhD Psi and
RhD-CE, which had been a challenge in other assays.
A separate version of the assay has also been approved as a
Clinical Trial Assay (CTA) by the FDA for use in a Phase III
clinical trial in a global collaboration with Janssen Research
& Development, LLC. In a separate study, this use case for
alloimmunized pregnancies has also shown 100% accuracy with more
than 500 newborn outcomes.
Currently, when the gestating parent is tested to be Rh
negative, Anti-D Immune Globulin is administered to any pregnant
person on any subsequent pregnancy at 28 weeks. In the event that
Rh incompatibility goes untreated, the parent's immune system sees
the baby's red blood cells as "foreign" and will try to eliminate
them as invaders by making anti-Rh antibodies. These antibodies can
cross the placenta and attack the fetus's red blood cells,
resulting in a variety of issues, including hemolytic disease of
the fetus and newborn (HDFN), a condition in which the red blood
cells of the fetus are destroyed by the mother's antibodies -
creating serious complications for the baby.
"The UNITY Fetal RhD NIPT is a reliable and convenient
alternative to the traditional methods of determining fetal RhD
status," said Dr. Nicole Plenty,
Maternal-Fetal Medicine Division Director at Wellstar Health
System. "This test's exceptional accuracy has enabled doctors to
alleviate concerns and anxieties among expectant parents facing the
uncertainty of RhD status in their pregnancies, particularly in the
light of the national RhoGAM shortage. Due to confidence in the
results of this test, physicians are able to dedicate resources
like RhoGAM to patients who truly need them."
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 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 www.billiontoone.com
For more information about the trial or the collaboration,
please contact [billiontoone@moxiegrouppr.com]
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SOURCE BillionToOne