Natera Announces Commercial Coverage for Prospera™ Kidney and Prospera Heart™ from a Top BCBS Plan
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Insights
The announcement by Natera, Inc. regarding the commercial insurance coverage for its Prospera Heart and Prospera Kidney tests signifies a notable advancement in the accessibility of transplant diagnostics. The Prospera tests, which utilize cell-free DNA (cfDNA) to monitor organ transplants, are pivotal in the early detection of graft rejection, which is crucial for patient outcomes. The endorsement of such tests by medical societies and their inclusion in insurance coverage can lead to a broader adoption in clinical practice.
From a research perspective, the peer-reviewed evidence cited by Natera underscores the clinical utility of the Prospera tests. The publication of results from the Trifecta Heart, DTRT and ProActive studies in reputable journals will likely strengthen the scientific community's trust in the tests' effectiveness. Moreover, the ongoing PEDAL and MOTR trials are expected to further substantiate the tests' benefits, potentially influencing future insurance coverage decisions and clinical guidelines.
The expansion of insurance coverage for Natera's Prospera tests by a major BCBS plan is a strategic milestone that could lead to increased revenue streams for the company. The inclusion of serial testing under the coverage policy is particularly significant as it ensures recurring use of the tests for patient monitoring. This decision by BCBS may prompt other insurers to follow suit, potentially broadening the market for Natera's tests.
It is important to note that the transplant diagnostic market is highly specialized and such advancements can have a ripple effect on the competitive landscape. The market's response to Natera's expanded coverage will be a key indicator of the company's market position and could influence investor sentiment. Stakeholders should monitor the adoption rates post-coverage expansion and the outcomes of the pending trials for a comprehensive understanding of the tests' market potential.
The announcement by Natera may be seen as a positive development for its financial health, considering that insurance coverage is a critical factor in product adoption and sales in the healthcare sector. The increased access to Prospera tests for commercially insured patients could lead to higher test volumes and, consequently, revenue growth. Investors should consider the potential increase in market share and revenue as a result of this coverage expansion, while also weighing the costs associated with the ongoing clinical trials.
Furthermore, the long-term financial impact will depend on the outcomes of the clinical trials and any subsequent changes in clinical practice guidelines. Positive trial results could enhance the tests' credibility and drive further adoption, whereas any setbacks could pose risks to projected growth. Investors should also be mindful of the competitive dynamics in the cfDNA testing space and the potential emergence of alternative technologies that could affect Natera's market position.
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
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.
View source 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
Source: Natera, Inc.
FAQ
What tests received commercial insurance coverage from a major Blue Cross Blue Shield plan in the U.S.?
What does Prospera analyze to evaluate the risk of organ transplant rejection?
Why is the commercial insurance coverage significant for transplant patients?
How many peer-reviewed manuscripts have featured Natera's organ health products?
What are the names of the ongoing trials by Natera to support the clinical utility of Prospera?
