Natera Announces Publication of Largest Prospective dd-cfDNA Study in Kidney Transplantation
April 11 2024 - 8:00AM
Business Wire
ProActive study shows Natera’s Prospera Kidney™
test detects rejection five months before biopsy
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
(cfDNA) testing, today announced a new publication from the
ProActive study in Transplantation supporting the use of the
Prospera Kidney donor-derived cfDNA (dd-cfDNA) test as a leading
indicator of kidney transplant rejection. The published manuscript
can be found here.
The ProActive study is the largest prospective dd-cfDNA study in
kidney transplant recipients, with roughly 5,000 patients enrolled
at 54 participating transplant centers. This published study
included 1,631 patients with ≥18 months of follow-up data. Key
findings include:
- dd-cfDNA levels were significantly elevated up to five months
before biopsy-proven antibody-mediated acute rejection (ABMR) and
up to two months before biopsy-proven T cell-mediated rejection
(TCMR) compared to patients with a non-rejection biopsy. In
contrast, serum creatinine levels were not significantly elevated
at any time point before biopsy-proven TCMR or ABMR.
- Multiple increased dd-cfDNA results were associated with lower
eGFR, high immunological risk factors, and suspected ABMR in the
absence of rejection on biopsy. These data further support the
Prospera Kidney test’s value as an early indicator of rejection vs
biopsy.
- Real-world performance of the Prospera Kidney test to detect
all forms of rejection in 249 patients with matched biopsy
demonstrated an area under the curve of 0.88, showcasing
performance consistent with prior validations.1-4
“The ProActive study reinforces the utility of dd-cfDNA for
monitoring kidney transplant patients and identifying those most at
risk for rejection early on,” said Jonathan Bromberg, MD, professor
of surgery and microbiology and immunology, vice chair for research
at the University of Maryland School of Medicine, and principal
investigator of the ProActive study. “By detecting elevations in
dd-cfDNA before biopsy-proven rejection, we can open up a critical
window of time when more effective treatments can be used to
improve the chances of graft survival.”
“Current transplant surveillance tools are often lagging or
inaccurate, and have several known limitations,” said Sangeeta
Bhorade, MD, chief medical officer of organ health at Natera. “We
believe the ProActive study provides robust evidence in support of
regular surveillance with the Prospera dd-cfDNA test, which the
industry has long been awaiting. Natera remains excited to continue
pursuing additional clinical evidence and optimizing the management
of kidney transplant patients for improved long-term outcomes.”
About the Prospera test
The Prospera™ 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. It 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 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 180 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
- Sigdel TK, Archila FA, Constantin T, et al. Optimizing
Detection of Kidney Transplant Injury by Assessment of
Donor-Derived Cell-Free DNA via Massively Multiplex PCR. J Clin
Med. 2018;8(1):19.
- Halloran PF, Reeve J, Madill-Thomsen KS, et al. Combining
Donor-derived Cell-free DNA Fraction and Quantity to Detect Kidney
Transplant Rejection Using Molecular Diagnoses and Histology as
Confirmation. Transplantation. 2022;106(12): 2435-2442.
- Bunnapradist S, Homkrailas P, Ahmed E, Fehringer G, Billings P,
Tabriziani H. Using both the Fraction and Quantity of Donor-Derived
Cell-Free DNA to Detect Kidney Allograft Rejection. J. Am. Soc.
Nephrol. 2021;32(10), 2439-2441.
- Bromberg J, Bunnapradist S, Samaniego-Picota Milagros, et al.
Elevation of Donor-derived Cell-free DNA Before Biopsy-proven
Rejection in Kidney Transplant. Transplantation. 2024.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240411734243/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
Natera (NASDAQ:NTRA)
Historical Stock Chart
From May 2024 to Jun 2024
Natera (NASDAQ:NTRA)
Historical Stock Chart
From Jun 2023 to Jun 2024