Natera Launches Differentiated New Feature for Prospera™ Heart Test, Enhancing Detection of Rejection for Transplant Patients
17 June 2024 - 9:00PM
Business Wire
Donor Quantity Score (DQS) technique is unique
to Natera, improving detection of both acute cellular rejection and
antibody-mediated rejection
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
(cfDNA) and genetic testing, today announced the launch of Prospera
Heart™ with Donor Quantity Score (DQS), further enhancing
Prospera’s ability to detect rejection in heart transplant
patients.
Traditionally, donor-derived cell-free DNA (dd-cfDNA) tests have
reported rejection risk based only on the fraction of dd-cfDNA in
the blood vs. the total cfDNA (dd-cfDNA %). This fraction can be
confounded by fluctuations in the amount of background total cfDNA
(the denominator), which are sometimes caused by factors unrelated
to the health of the transplant, including infection, surgery, or
chemotherapy.
Prospera Heart now incorporates a second metric – the DQS – that
normalizes for the background total cfDNA. Prospera Heart with DQS
combines the traditional donor fraction and the new DQS into a
two-threshold algorithm, delivering a single result with more
accurate risk assessment for both antibody mediated rejection (AMR)
and acute cellular rejection (ACR).
“Over the last two decades, Natera has pioneered cfDNA testing
across women’s health, oncology, and transplant medicine,” said
Michael Olymbios, M.D., Medical Director, Heart Transplant. “Our
extensive experience with cfDNA and Natera’s culture of continuous
innovation drove us to further refine Prospera Heart by introducing
this two-threshold algorithm to better serve the transplant
community.”
A study performed at the University of Utah and the University
of California San Diego showed that incorporating DQS enhanced the
performance of Prospera Heart in screening for biopsy-proven active
rejection. In an initial analysis of 703 plasma samples, the
two-threshold algorithm, as compared to the traditional dd-cfDNA %
alone, improved several key performance metrics as follows:
- Sensitivity increased from 80.0% to 88.2%
- Specificity increased from 76.1% to 84.2%, reducing false
positive results by 37.5%
- Increased negative predictive value (NPV) from 97.4% to
98.6%
The study was presented at The International Society for Heart
and Lung Transplantation’s annual meeting in April 2024, and it
will be submitted for peer-reviewed publication later this
year.
“The initial findings from our study indicate that DQS
complements donor fraction and provides a clearer picture of
rejection risk for the patient, compared to donor fraction alone,”
said Josef Stehlik, M.D., M.P.H., Medical Director of the Heart
Transplant Program and Co-chief of the Advanced Heart Failure
Program at the University of Utah Hospital. “We believe this
innovative technique can lead to fewer unnecessary biopsies and
follow-up procedures for heart transplant recipients given the
increase in sensitivity.”
A similar two-threshold dd-cfDNA test for assessing the risk of
kidney transplant rejection, Prospera Kidney with Quantification,
was published in the Journal of the American Society of Nephrology1
and has been offered by Natera for kidney transplant patients since
2021.
About Prospera
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.
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
- Bunnapradist S, Homkrailas, P, Ahmed, E, et al. Using both the
fraction and quantity of donor-derived cell-free DNA to detect
kidney allograft rejection, J Amer Soc Nephrology 2021; 32(10):
2439-2441.
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version on businesswire.com: https://www.businesswire.com/news/home/20240617097740/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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