Benzinga | Oct 6, 2021 08:36AM EDT

Natera Reports Completion Of Its Validation Study Of A Commercial Cell-Free DNA Test In Lung Transplants

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(tm) 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."