Natera Announces Commercial Coverage for Prospera™ Kidney and Prospera Heart™ from a Top BCBS Plan
March 07 2024 - 7:00AM
Business Wire
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
(cfDNA) testing, today announced that it has received commercial
insurance coverage for its Prospera Heart and Prospera Kidney tests
from one of the largest Blue Cross Blue Shield (BCBS) plans in the
U.S. Prospera is a non-invasive blood test that analyzes
donor-derived cfDNA (dd-cfDNA) to evaluate the risk of organ
transplant rejection.
The coverage policy includes serial testing with Prospera to
assess graft status and identify the risk of rejection following a
kidney or heart transplant. Commercially insured patients have
historically had limited access to dd-cfDNA testing, but that is
changing as a result of recent medical society endorsements and
guidelines that support the use of dd-cfDNA.1-3
“We are thrilled with this new policy, which increases access to
Prospera for commercially insured transplant patients and adds to
the existing Medicare coverage in heart, kidney, and lung,” said
Bernie Tobin, general manager of organ health at Natera. “Improving
long-term outcomes for this population starts with more accurate
and non-invasive tools to identify potential graft issues
earlier.”
Natera and its academic partners have published significant
peer-reviewed evidence supporting the clinical utility of Prospera.
Natera’s organ health products have been featured in 39
peer-reviewed manuscripts, which have been published or accepted in
top journals, including the recently accepted publications from the
Trifecta Heart, DTRT, and ProActive studies. In addition, Natera
has completed enrollment in the PEDAL and MOTR trials. These are
both multi-site, prospective studies designed to provide novel
evidence supporting the clinical utility of Prospera, with expected
publication in 2024.
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, our expectations of the benefits of our tests and product
offerings to patients, providers and payers, or coverage and
reimbursement determinations from third-party 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
- American Society of Transplant Surgeons. ASTS Statement on
donor-derived cell-free DNA (dd cf-DNA). asts.org.
https://asts.org/docs/default-source/position-statements/dd-cfdna-position-statement.pdf.
Accessed March 7, 2024.
- Kobashigawa J, Hall S, Shah P, et al. The evolving use of
biomarkers in heart transplantation: consensus of an expert panel.
Am J Transplant. 2023;23(6):727-735. doi:
https://doi.org/10.1016/j.ajt.2023.02.025.
- The European Society for Organ Transplantation. ESOT TLJ
Consensus Conference Highlights Report. esot.org.
https://esot.org/wp-content/uploads/2023/03/EM012464_TLJ_3_0_Scientific_Highlights_Report_230316_V0-7_SMB.pdf.
Accessed March 7, 2024.
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version on businesswire.com: https://www.businesswire.com/news/home/20240307491560/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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