NEW YORK ─ Minneapolis-based Bio-Techne and Los Angeles-based Nonagen Bioscience on Thursday announced an agreement for the manufacture of Nonagen's Oncuria bladder cancer diagnostic testing panel by Bio-Techne's R&D Systems.
Financial and other terms of the agreement were not disclosed.
Oncuria is a protein-based urine test that uses xMap technology developed by DiaSorin's Luminex for the early detection, therapy choice, and disease monitoring of bladder cancer. The multiplex immunoassay measures 10 protein biomarkers in a single voided urine sample.
Bio-Techne and Nonagen Bioscience are targeting the last quarter of this year to launch Oncuria as a laboratory-developed test.
In September 2021, the US Food and Drug Administration granted a breakthrough device designation to Oncuria for predicting response to Bacillus Calmette-Guérin therapy, a first-line treatment for bladder cancer. The designation enables close collaboration with the FDA, as well as expedited review of the assay, the firms noted.