Natera, Inc. Expands Organ Health Business With Commercial Launch of the Prospera Lung Transplant Assessment Test
October 18, 2021 at 08:33 am EDT
Share
Natera, Inc. 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 large 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. 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.
Natera, Inc. is a diagnostics company, which is focused on the development and commercialization of molecular testing services, applying its technology in the fields of womenâs health, oncology and organ health. Its cell-free deoxyribonucleic acid (cfDNA) technology combines its molecular assays, which reliably measure many informative regions across the genome from samples as small as a single cell. The Company's product offerings include Panorama Non-Invasive Prenatal Test (NIPT), Vistara, Horizon Carrier Screening, Spectrum Preimplantation Genetics, Anora Miscarriage Test, Empower, and Prospera. The Company also offers Constellation, a cloud-based software platform that enables laboratory customers to gain access through the cloud to the Companyâs algorithms and bioinformatics in order to validate and launch tests based on the Companyâs technology. Its NIPT screens for chromosomal abnormalities of a fetus as well as in twin pregnancies, typically with a blood draw from the mother.
NATERA, INC. 
