Natera Expands Organ Health Business With Commercial Launch of the Prospera™ Lung Transplant Assessment Test

Rhea-AI Summary

Natera, Inc. (NASDAQ: NTRA) has launched the Prospera Lung test, expanding its organ health offerings to include lung transplant assessments. Validated in the VALID study, this non-invasive test achieves a negative predictive value of 97.33% and 89.06% sensitivity, distinguishing between stable patients and acute rejection effectively. Natera also announced two new studies to compare Prospera against traditional biopsy methods. The company aims to improve patient outcomes among lung transplant recipients, addressing a significant clinical need for accurate monitoring.

Positive

• Launch of the Prospera Lung test expands Natera's organ health portfolio.
• Prospera shows strong validation results with 97.33% negative predictive value and 89.06% sensitivity.
• New studies to demonstrate non-inferiority of Prospera vs. biopsy may enhance market adoption.

Negative

• The Prospera test is not yet approved by the FDA.

AUSTIN, Texas, Oct. 18, 2021 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a leader in transforming care through genetic and cell-free DNA (cfDNA) testing, announced the launch and availability of its Prospera donor-derived cfDNA (dd-cfDNA) transplant assessment test for lung transplant recipients. The launch represents the latest addition to Natera's transplant monitoring portfolio beyond kidney and heart transplantation.

Natera validated the Prospera Lung test in the VALID study, the largest prospective trial of a commercial dd-cfDNA test for lung transplant assessment. The results, presented at CHEST 2021 and submitted for peer-reviewed publication, show the Prospera Lung test distinguishes antibody mediated and acute cellular rejection from stable patients with excellent performance, achieving an NPV of 97.33%, sensitivity of 89.06% and AUC of 0.91.¹ The Prospera Lung test was also able to distinguish organ injury—including acute rejection, chronic rejection and infection (which can be more challenging)—from stable patients, with an AUC of 0.76.

"There is a strong unmet need for more accurate, noninvasive surveillance tests that may obviate the need for biopsy and improve the poor survival rate among lung transplant patients," said Brian Keller, M.D., Ph.D., the study's principal investigator from The Ohio State University Wexner Medical Center. "In our study, we show that dd-cfDNA can be a promising biomarker for monitoring lung transplants and detecting acute rejection. I'm pleased to see this technology, which is a major breakthrough in the field of lung transplantation, being offered more broadly."

The gold standard of transbronchial biopsy (TBB) has several limitations including being invasive, costly and carrying the risk of complications. Natera is therefore launching LAMBDA 001, a randomized controlled trial to demonstrate non-inferiority for Prospera surveillance vs biopsy, as well as LAMBDA 002, an observational registry study to assess Prospera performance for detection of chronic lung allograft dysfunction (CLAD), the leading cause of mortality among lung transplant recipients.

"We're excited to bring our history of innovation and expertise in cfDNA to the lung transplant community as we seek to improve health outcomes across multiple organs," said Bernie Tobin, general manager of Natera's organ health division. "The Prospera Lung test's strong validation data makes us well-positioned to expand significantly into the noninvasive lung transplant monitoring market, and we look forward to working closely with clinicians to introduce this test into clinical practice."

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 pioneer and global leader in cell-free DNA testing from a simple blood draw. The mission of the company is to change the management of disease worldwide with a focus on women's health, oncology, and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.

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 our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical or other studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening 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.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350
Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 pr@natera.com 

References

1. Natera clinical validation data. Manuscript submitted for publication.

 

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SOURCE Natera, Inc.

FAQ

What is the Prospera Lung test launched by Natera?

The Prospera Lung test is a non-invasive cfDNA test for assessing lung transplant recipients, helping to identify organ rejection.

What clinical study validated Natera's Prospera Lung test?

The Prospera Lung test was validated in the VALID study, the largest prospective trial of its kind.

What are the performance metrics of the Prospera Lung test?

The test achieved a negative predictive value of 97.33%, sensitivity of 89.06%, and an AUC of 0.91 in distinguishing rejection.

Is the Prospera Lung test approved by the FDA?

No, the Prospera Lung test has not yet received FDA approval.

What studies are Natera conducting related to the Prospera test?

Natera is conducting LAMBDA 001 to compare Prospera against biopsy and LAMBDA 002 to assess performance for chronic lung allograft dysfunction.