Natera Launches Fetal RhD NIPT Supporting Ob/Gyn Physicians and Patients During RhIg Shortage
01 Maggio 2024 - 1:00PM
Business Wire
Backed by large clinical validation study with
over 650 RhD-negative patients with confirmed outcomes, resulting
in 100% sensitivity and >99% specificity
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
(cfDNA) and genetic testing, today announced the launch of a new
cfDNA-based fetal RhD test. This comes at a critical time for the
healthcare industry, helping physicians navigate patient care given
nationwide shortages of Rho(D) immune globulin therapy (RhIg).
Natera’s test can be performed as early as nine weeks gestation
and determines fetal RhD status from the blood of a pregnant
patient, including complex pseudogene and RhD-CE-D hybrid variants.
The vast majority of other NIPT laboratories do not offer fetal RhD
assessment, which makes it a key differentiator in addition to
Natera’s core SNP-based technology.
Up to 15 percent of pregnant patients are RhD-negative1. When
the maternal blood type is RhD-negative and the fetal blood type is
RhD-positive, antibodies can develop (alloimmunization) that can
lead to hemolytic disease of the fetus and newborn. Historically,
this risk is well managed by giving RhIg to all RhD-negative
patients despite the fact that only 60%2 of them carry an
RhD-positive fetus. In response to the nationwide shortage of RhIg,
the American College of Obstetricians and Gynecologists (ACOG)
recently stated that using NIPT to “prioritize use of RhIg and
conserve RhIg supply is a reasonable consideration.”
The product launch is backed by a validation study that included
fetal RhD status confirmed via newborn serology in more than 650
RhD-negative pregnancies. This is roughly 10 times more patients
with confirmed outcomes than validation studies from other
laboratories. Natera’s test performed with 100% sensitivity and
greater than 99% specificity.
Natera’s study was accepted as a late-breaking abstract for
ACOG’s Annual Clinical & Scientific Meeting, and the results
will be presented at the meeting on May 18, 2024. This clinical
validation is Natera’s second study on fetal RhD. In 2023, Natera
presented data at the American Society of Human Genetics (ASHG)
Annual Meeting on 180 RhD-negative pregnancies, which showed
similar performance.
“Having an accurate, well-validated fetal RhD test is critical
given the current shortage of RhIg and the tremendous complications
alloimmunization can cause to a baby’s health in a subsequent
pregnancy,” said Victor Klein, M.D., M.B.A., System Director of
Quality & Patient Safety for Obstetrics & Gynecology at
Northwell Health. “It is especially important that clinicians have
access to these tools right now to help determine which patients
are most in need of RhIg.”
“We are proud to offer this highly validated fetal RhD test at a
time of critical need in the prenatal community,” said Jeffrey
Meltzer, M.D., Senior Medical Director, Women’s Health at
Natera.
The RhD test is a new offering within Natera’s women’s health
suite of products, which also includes Panorama, the No. 1 ordered
noninvasive prenatal test in the U.S.
About Panorama
Panorama screens for severe genetic disorders as early as nine
weeks into pregnancy. The test uses a unique single-nucleotide
polymorphism (SNP)-based technology to analyze fetal (placental)
DNA obtained through a maternal blood draw. It is the only
commercially available NIPT that differentiates between maternal
and fetal DNA to assess the risk of aneuploidies. Panorama has been
the subject of more than 40 peer-reviewed publications of over 2
million patients. Panorama has been developed and its performance
characteristics determined by Natera, the CLIA-certified laboratory
performing the test. The test has not been cleared or approved by
the US Food and Drug Administration (FDA). CAP accredited, ISO
13485 certified, and CLIA certified.
About Natera
Natera™ is a global leader in cell-free DNA and genetic testing,
dedicated to oncology, women’s health, and organ health. We aim to
make personalized genetic testing and diagnostics part of the
standard of care to protect health, and inform earlier, more
targeted interventions that help lead to longer, healthier lives.
Natera’s tests are validated by more than 200 peer-reviewed
publications that demonstrate high accuracy. Natera operates ISO
13485-certified and CAP-accredited laboratories certified under the
Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas
and San Carlos, California. For more information, visit
www.natera.com.
Forward-Looking Statements
All statements other than statements of historical facts
contained in this press release are forward-looking statements and
are not a representation that Natera’s plans, estimates, or
expectations will be achieved. These forward-looking statements
represent Natera’s expectations as of the date of this press
release, and Natera disclaims any obligation to update the
forward-looking statements. These forward-looking statements are
subject to known and unknown risks and uncertainties that may cause
actual results to differ materially, including with respect to
whether the results of clinical or other studies will support the
use of our product offerings, the impact of results of such
studies, or our expectations of the benefits of our tests and
product offerings to patients, providers and payers. Additional
risks and uncertainties are discussed in greater detail in "Risk
Factors" in Natera’s recent filings on Forms 10-K and 10-Q and in
other filings Natera makes with the SEC from time to time. These
documents are available at www.natera.com/investors and
www.sec.gov.
References
- Zipursky A, Paul VK. The global burden of Rh disease. Arch Dis
Child Fetal Neonatal Ed 2011;96:F84–5. (Level III)
- ACOG. Practice Bulletin 181: Prevention of Rh D
Alloimmunization. 2017.
https://journals.lww.com/greenjournal/fulltext/2017/08000/practice_bulletin_no__181_summary__prevention_of.48.aspx
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version on businesswire.com: https://www.businesswire.com/news/home/20240501580629/en/
Investor Relations: Mike Brophy, CFO, Natera, Inc.,
510-826-2350, investor@natera.com Media: Lesley Bogdanow, VP of
Corporate Communications, Natera, Inc., pr@natera.com
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