Natera Announces Completion of the Largest Prospective Validation Study of a Commercial Cell-Free DNA Test in Lung Transplantation
October 06, 2021 at 08:33 am EDT
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Natera, Inc. announced the completion of the VALID Study (Validation for Allograft Lungs Implementing Donor-derived cell-free DNA) for Prospera™ in lung transplant recipients. 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. 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.
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.
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