Benzinga | Oct 18, 2021 08:35AM EDT

Natera Reports Commercial Launch Of Prospera Lung Transplant Assessment Test

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."