Natera Announces New Data From Two Studies Extending the Clinical Validation of Its Prospera™ Heart dd-cfDNA Test for Heart Transplant Recipients
08 Abril 2024 - 7:00AM
Business Wire
Prospective, multi-center Trifecta-Heart and
DTRT-2 studies demonstrate excellent performance of the Prospera
Heart test for detecting rejection in adults and pediatrics
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
(cfDNA) testing, today announced the publication of two major
studies, DTRT-2 and Trifecta-Heart, showcasing the ability of the
Prospera Heart donor-derived cfDNA (dd-cfDNA) test to detect
rejection in adult and pediatric heart transplant recipients. These
are the second and third peer-reviewed publications evaluating
Natera’s technology for use in heart transplantation.
“We are encouraged by the results of these two prospective
studies,” said Sangeeta Bhorade, MD, chief medical officer of organ
health at Natera. “The consistent, excellent performance of
Prospera Heart across multiple independent studies should inspire
confidence among transplant physicians to leverage Prospera as part
of standard patient care.”
The Prospera Heart test was launched in 2021 and received
Medicare coverage following the 2022 publication of a multi-site
clinical validation study, the DEDUCE study, in the Journal of
Heart and Lung Transplantation. That study showed the Prospera
Heart test had an overall area under the curve (AUC) of 0.86 for
identifying acute rejection in over 800 samples from 200 adults
with heart transplants.
The DTRT-2 (DNA-Based Transplant Rejection Test) study,
published recently in Pediatric Transplantation, was sponsored by
the National Institutes of Health (NIH). A total of 487 samples
from 160 heart transplant recipients were evaluated, of which 78
were pediatric and 82 were adult patients. The Prospera Heart test
demonstrated outstanding performance in detecting rejection, as
determined by histopathology from endomyocardial biopsies (EMBs),
with an AUC of 0.82 in adult patients and 0.83 in pediatric
patients. The study reported a negative predictive value (NPV) of
92% for adult patients and 99% for pediatric patients, supporting
the intended use of Prospera Heart as a rule-out test to help
obviate surveillance biopsy procedures.
“DTRT-2 is a landmark study that further demonstrates that the
Prospera Heart test is a highly reliable, non-invasive tool for
detecting heart transplant rejection in adult patients, and now
solidifies that outstanding performance for pediatric patients as
well,” said Shriprasad R. Deshpande, MBBS, MS, director of the
Advanced Cardiac on Therapies and Heart Transplant Program,
Children’s National Hospital, and lead author of the study. “Based
on these findings, I believe the Prospera Heart test has the
potential to greatly reduce the number of invasive surveillance
biopsies in children and enhance their quality of life.”
The Trifecta-Heart study had its initial publication last week
in Transplantation and has an upcoming oral presentation at the
2024 International Society for Heart and Lung Transplantation
(ISHLT) Annual Meeting. This initial readout included 137 plasma
samples analyzed using the Prospera Heart test, correlated with
matched EMBs analyzed using the Molecular Microscope® Diagnostic
System (MMDx), a more objective reference standard for rejection
compared to histopathology. Based on data collected in the first 18
months, the Prospera Heart test was highly accurate in
distinguishing acute rejection from non-rejection, with an AUC of
0.90 and a NPV of 96%. These results affirm the strong performance
of Prospera Heart shown in the DEDUCE study.
Roughly 4,100 heart transplants are performed each year in the
U.S., including about 490 pediatric recipients in 2022.1 Biopsies,
which are the current standard of care for heart transplant
surveillance, have a complication rate ranging between 1-5%.2-6
Further, due to modern immunosuppression regimens, acute rejection
rates, as detected by surveillance biopsies, are now lower than the
rate of biopsy complications.7 This highlights the imbalance in
risk versus reward and argues in favor of a non-invasive
alternative to monitor for rejection.
These latest data come just before the 2024 ISHLT Annual
Meeting, where Natera will deliver one oral presentation and six
poster presentations related to its Prospera Heart and Prospera
Lung tests.
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, 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
- Organ Procurement and Transplantation Network (OPTN) and
Scientific Registry of Transplant Recipients (SRTR). OPTN/SRTR 2022
Annual Data Report: Heart. U.S. Department of Health and Human
Services, Health Resources and Services Administration. 2024.
Accessed April 4, 2024.
https://srtr.transplant.hrsa.gov/annual_reports/2022/Heart.aspx#fig:HRtx-adult-counts-all
- Bermpeis K, Esposito G, Gallinoro E, et al. Safety of right and
left ventricular endomyocardial biopsy in heart transplantation and
cardio-myopathy patients. JACC Heart Fail. 2022;10:963–973.
- Strecker T, R�sch J, Weyand M, et al. Endomyocardial biopsy for
monitoring heart transplant patients: 11-years-experience at a
German heart center. Int J Clin Exp Pathol. 2013;6:55–65.
- Deckers JW, Hare JM, Baughman KL. Complications of transvenous
right ventricular endomyocardial biopsy in adult patients with
cardio-myopathy: a seven-year survey of 546 consecutive diagnostic
procedures in a tertiary referral center. J Am Coll Cardiol.
1992;19:43–47.
- Hamour IM, Burke MM, Bell AD, et al. Limited utility of
endomyocardial biopsy in the first year after heart
transplantation. Transplantation. 2008;85:969–974.
- Hull JV, Padkins MR, Hajj SE, et al. Risks of right heart
catheterization and right ventricular biopsy: a 12-year,
single-center experience. Mayo Clin Proc. 2023;98:419–431.
- Cusi V, Vaida F, Wettersten N, et al. Incidence of Acute
Rejection Compared With Endomyocardial Biopsy Complications for
Heart Transplant Patients in the Contemporary Era. Transplantation.
2023. Epub ahead of print. PMID: 38098137.
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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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