Natera Announces Completion of the Largest Prospective Validation Study of a Commercial Cell-Free DNA Test in Lung Transplantation

Rhea-AI Summary

Natera has completed the VALID Study, the largest clinical validation of a commercial cell-free DNA test for lung transplantation. The study involved 204 plasma samples from 104 lung transplant recipients and was accepted as a late-breaking abstract for presentation at CHEST 2021 (October 17-20). This study highlights the significance of donor-derived cell-free DNA (dd-cfDNA) testing in improving patient outcomes. Natera's Prospera test has previously shown success in kidney and heart transplant assessments, indicating its potential in lung transplant situations as well.

Positive

• Completion of the VALID Study, the largest prospective validation of a commercial cell-free DNA test for lung transplantation.
• Study acceptance as a late-breaking abstract at CHEST 2021, indicating strong interest in Prospera test.
• Prospera test already validated for kidney and heart transplant assessments, showcasing expanding applications.

Negative

• None.

AUSTIN, Texas, Oct. 6, 2021 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a leader in improving patient outcomes through genetic and cell-free DNA (cfDNA) testing, announced the completion of the VALID Study (Validation for Allograft Lungs Implementing Donor-derived cell-free DNA) for Prospera™ in lung transplant recipients. This clinical validation study has been accepted as a late-breaking abstract for presentation at the American College of Chest Physicians (ACCP) international online meeting, CHEST 2021, to be held on October 17–20, 2021.

The prospective study conducted by The Ohio State University (OSU) lung transplant program examined 204 plasma samples obtained with concurrent bronchoscopy biopsy procedures from 104 lung transplant recipients between September 2020 and June 2021. Using the Prospera Lung test, donor-derived cell-free DNA (dd-cfDNA) levels were compared across clinical-histopathologic diagnostic cohorts. During the study, 35 episodes of acute rejection were captured for analysis. This study represents the largest prospective trial of a commercial dd-cfDNA test for lung transplant assessment.

"We're proud to partner with Natera, a leader in dd-cfDNA testing, on this important study as we seek to improve outcomes for patients living with lung transplants by exploring new technologies and advancing the standard of care," said Brian Keller, M.D., Ph.D., associate professor of medicine in the division of pulmonary and critical care medicine at OSU and the study's principal investigator. "The acceptance of this late-breaking abstract underscores the transplant community's interest in the Prospera test and the potential for dd-cfDNA testing after lung transplantation."

The abstract, titled "A Spectrum of Immunologic Events is associated with Elevated Donor-derived Cell-free DNA after Lung Transplantation", will be presented at CHEST 2021 by Justin Rosenheck, M.D., assistant professor of medicine at OSU.

Today's announcement comes on the heels of Natera's Prospera Heart launch, whose validation included a multi-site prospective study of more than 250 samples collected in 2020-2021, combined with previously collected heart samples, for a total validation of greater than 350 samples.

"The Prospera test has been clinically validated as a tool for assessing both kidney and heart rejection in transplant patients, and we are thrilled to validate it for lung transplant assessment as well," said David Ross, M.D., FCCP, medical director of lung transplantation at Natera. "We look forward to the strong results being presented at the upcoming CHEST annual meeting. Our goal is to provide the most accurate tests to help physicians diagnose early rejection and ultimately improve health outcomes for thousands of patients."

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 assessment of active rejection regardless of 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 

 

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SOURCE Natera, Inc.

FAQ

What is the VALID Study conducted by Natera?

The VALID Study is a clinical validation study for the Prospera test, assessing donor-derived cell-free DNA in lung transplant recipients.

When will the results of Natera's VALID Study be presented?

The study results will be presented at the CHEST 2021 conference, held from October 17-20, 2021.

How many lung transplant recipients were involved in Natera's VALID Study?

The VALID Study involved 104 lung transplant recipients.

What does the Prospera test measure?

The Prospera test measures donor-derived cell-free DNA to assess organ transplant rejection.

What are the positive outcomes expected from Natera's VALID Study?

The study aims to improve patient outcomes in lung transplantation through advanced dd-cfDNA testing.