Natera Presents Latest in Transplant Innovation Data Across Multiple Organs at ATC 2024
May 30 2024 - 8:00AM
Business Wire
Includes new results from the ProActive study,
reinforcing the utility of the Prospera™ Kidney test for ongoing
surveillance of transplant rejection
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
(cfDNA) and genetic testing, today announced that the company will
present new data on its Prospera donor-derived cfDNA (dd-cfDNA)
test at the American Transplant Congress (ATC) 2024 taking place
June 1–5, 2024.
Natera and its collaborators will present 18 abstracts
highlighting new Prospera data across heart, lung, kidney, and
multi-organ transplantation. This includes an oral presentation
highlighting the predictive capabilities of the Prospera Kidney
test from the ProActive study, the largest prospective dd-cfDNA
study in kidney transplant recipients.
“We look forward to sharing new research at ATC that
demonstrates the breadth of clinical evidence supporting Prospera
across multiple organ types,” said Sangeeta Bhorade, MD, chief
medical officer of organ health at Natera. “This includes new data
from the landmark ProActive study, reinforcing the value of the
Prospera Kidney test as a highly accurate surveillance tool for
detecting ongoing organ rejection and predicting future
rejection.”
Highlights from selected abstracts
include:
- Oral Presentation | Abstract # 362 | Presenter: Elliot
Aguilar, PhD | June 2, 3:00 PM - 4:00 PM ET | Prospera Kidney
Exploring Total and Donor Cell-Free DNA in Kidney Transplants: A
Differential Rejection Analysis of Antibody Mediated and T-Cell
Mediated Rejections Results from 1,022 kidney transplant patients
enrolled in the ProActive study showed excellent performance of the
Prospera Kidney test for predicting allograft rejection when
combining clinical factors and key biomarkers with longitudinal
testing, improving performance further (area under the curve range:
92-96%).
- Poster Presentation | Abstract # A172 | Presenter: Milagros
Samaniego-Picota, MD | June 1, 5:30 - 7:00 PM ET | Prospera
Kidney Clinically Significant Variation of dd-cfDNA in Kidney
Transplant Recipients Results from 866 stable kidney transplant
patients enrolled in the ProActive study show that a change of
dd-cfDNA fraction of more than 72.9% between sequential results may
indicate clinical significance and be especially useful for the
interpretation of borderline results. Additionally, longitudinal
variance within an individual supports the need for surveillance to
establish baseline values.
- Poster Presentation | Abstract # C215 | Presenter: Suphamai
Bunnapradist, MD, MS | June 3, 9:15 - 10:00 AM ET & 2:30 - 3:15
PM ET | Prospera Kidney Longitudinal dd-cfDNA trends and
clinical outcomes in kidney transplant recipients Findings from 370
kidney transplant patients enrolled in the ProActive study suggest
that dd-cfDNA trends may allow for the stratification of patients
into different risk categories. Notably, dd-cfDNA levels
consistently below 0.3% were associated with a low incidence of
adverse outcomes. The likelihood of adverse events increased with
additional elevations in dd-cfDNA.
- Poster Presentation | Abstract # A178 | Presenter: Hossein
Tabriziani, MD, PhD | June 1, 5:30 - 7:00 PM ET | Prospera
Kidney Is dd-cfDNA Prognostic for Future Kidney Allograft
Rejection? In 452 kidney transplant patients, elevated dd-cfDNA at
the time of a non-rejection biopsy was significantly associated
with future allograft rejection, suggesting that patients with
elevated dd-cfDNA should be considered at high risk for future
rejection and monitored closely.
Additionally, Natera will host a lunch symposium on June 2nd
from 12:15 - 1:15 PM ET titled, “Monitoring matters: Latest data
supporting Prospera™ dd-cfdna for routine kidney transplant care.”
It will include participation from Zahraa Hajjiri, MD,
assistant professor of medicine, interim UNOS medical director,
Transplant Nephrology, AST Transplant Nephrology Fellowship
Director, University of Illinois-Chicago, Anil Chandraker,
MD, professor of medicine, UMass Chan School of Medicine,
chief, division of Renal Medicine, UMass Memorial Health Care, and
Ali Zarrinpar, MD, PhD, professor, University of
Florida College of Medicine, University of Florida Health.
The data being presented at ATC adds to the growing body of
research supporting Natera’s organ health tests, which includes
over 40 peer-reviewed publications.
About the Prospera test
The ProsperaTM test leverages Natera’s core single-nucleotide
(SNP)-based massively multiplexed PCR (mmPCR) technology to
identify allograft rejection non-invasively and with high precision
and accuracy, without the need for prior donor or recipient
genotyping. The test works by measuring the fraction of
donor-derived cell-free DNA (dd-cfDNA) in the recipient’s blood. It
may be used by physicians considering the diagnosis of active
rejection, helping to rule in or out this condition when evaluating
the need for diagnostic testing or the results of an invasive
biopsy. The Prospera test has been clinically and analytically
validated for performance regardless of donor relatedness,
rejection type, and clinical presentation.
About Natera
NateraTM is a global leader in cell-free DNA testing 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240530845740/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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