COMPANY:

Nonagen BioSci

"Nonagen Bioscience...announced today several strategic milestones as it positions for its next phase of growth. As the completion of pivotal clinical trials draws near for its Oncuria® suite of bladder cancer tests, including Oncuria-Detect™ and Oncuria-Monitor™, the company has multiple FDA submissions in the works and plans to expand its clinical partnerships. Recent collaboration with large national laboratory provider signals growing market interest in precision, non-invasive diagnostics for urologic oncology. Nonagen has also broadened its pipeline with the development of Nexus-Dx™, a neoadjuvant chemotherapy response predictor for bladder cancer, and FibraChek™, a novel non-invasive test for assessing liver fibrosis in at-risk populations."

"DiaCarta, Ltd...announced the successful completion of the validation study of Oncuria^® multiplex bladder cancer immunoassay as a laboratory developed test ('LDT'). DiaCarta also announced that it has begun receiving patient urine samples for testing in its CLIA certified lab in Pleasanton, California."

"Nonagen Bioscience...announced CE marking for its Oncuria® immunoassay for bladder cancer...Oncuria now bears the CE marking and is registered under the EU In Vitro Diagnostic Directive (IVDD), EU Directive 98/79/EC, which allows Nonagen to sell the diagnostic in the European market."

"Nonagen Bioscience and Bio-Techne Corporation...announced an agreement for R&D Systems, a Bio-Techne brand, to exclusively manufacture Nonagen Bioscience’s Oncuria® bladder cancer diagnostic panel using xMAP Luminex® technology...Nonagen Bioscience and Bio-Techne are targeting the last quarter of calendar 2022 to make Oncuria available as an LDT."

"Peregrine Market Access...has been selected by Nonagen Bioscience to become its contract commercialization organization for Oncuria, a breakthrough bladder cancer diagnostic test that is being developed to aid in detection, therapy choice, and disease monitoring. Under a multiyear, multimillion dollar agreement, Peregrine Market Access will lead the United States launch of Oncuria."