Natera’s Prospera™ Lung Transplant Assessment Test Granted Medicare Coverage
16 Agosto 2023 - 10:00AM
Business Wire
Represents third covered indication for
Prospera
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
(cfDNA) testing, today announced that it has received confirmation
that its Prospera Lung donor-derived cfDNA (dd-cfDNA) transplant
assessment test has met coverage requirements from the Centers for
Medicare & Medicaid Services’ (CMS) Molecular Diagnostics
Services Program (MolDX).
The MolDX technology assessment program has determined that
Prospera Lung will be covered under the existing Medicare Local
Coverage Determination for Molecular Testing for Solid Organ
Allograft Rejection for use in the surveillance setting in lung
transplant patients.
Lung transplantation has a five-year survival rate of 59%, the
lowest rate of all transplanted organs. Moreover, in the last 20
years, there has been limited improvement in recipient survival.1
This is primarily driven by acute rejection (AR) and chronic lung
allograft dysfunction (CLAD), which is the leading cause of
mortality among lung transplant recipients.2
“The current standard of using transbronchial biopsy for
monitoring lung transplant rejection is associated with significant
procedural risks and complications and is a physical and emotional
burden on the patient,” said Howard J. Huang, M.D., associate
professor of clinical medicine, division of pulmonary, critical
care, and sleep medicine at Houston Methodist Hospital. “Prospera
Lung fulfills a critical unmet need for a less invasive method of
detecting acute rejection to help guide biopsy decision-making and
inform treatment.”
The Prospera Lung clinical validation, the VALID study,3 was
published in 2022 and highlighted performance from 195
biopsy-matched samples from 103 patients. This blinded, prospective
study analyzed Prospera Lung in connection with various
complications from lung transplantation, including AR, CLAD and
allograft infection. The study demonstrated outstanding
performance, with an area under the curve of .91 when analyzing AR
versus stable patients.
“Medicare’s decision enables broad access to the Prospera Lung
test and represents a significant win for lung transplant patients
and the field of transplant monitoring,” said Bernie Tobin, general
manager of organ health at Natera. “Prior to this decision, nearly
50 percent of the top 50 transplant centers have used Prospera
Lung. We are encouraged by this momentum and gratified by the
ongoing support from members of the transplant community who
understand the clinical utility of dd-cfDNA testing and the
critical benefits it can bring to patients.”
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. 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
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 150 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
- Chambers DC, Perch M, Zuckermann A, et al. The International
Thoracic Organ Transplant Registry of the International Society for
Heart and Lung Transplantation: Thirty-eighth adult lung
transplantation report - 2021; Focus on recipient characteristics.
J Heart Lung Transplant. 2021;40(10):1060-1072.
- Bedair B and Hachem RR. Management of chronic rejection after
lung transplantation. J Thorac Dis. 2021;13(11): 6645–6653.
- Rosenheck JP, Ross DJ, Botros M, et al. Clinical Validation of
a Plasma Donor-derived Cell-free DNA Assay to Detect Allograft
Rejection and Injury in Lung Transplant. Transplant Direct.
2022;8(4):e1317.
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version on businesswire.com: https://www.businesswire.com/news/home/20230816491383/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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