NEW YORK — Nonagen Bioscience said on Thursday that it has received CE marking for its Oncuria bladder cancer immunoassay.
The 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 urine sample.
Los Angeles-based Nonagen said that it expects a fourth quarter launch of Oncuria in the US as an in vitro diagnostic with a commercial rollout in Europe shortly thereafter. The test received a breakthrough device designation from the US Food and Drug Administration in late 2021.
Last month, Nonagen partnered with Bio-Techne to manufacture the test.