SARATOGA SPRINGS/LOS ANGELES, CA — Peregrine Market Access, a leading life science commercialization partner, 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.
Nonagen Bioscience’s Oncuria is a cutting-edge multiplex immunoassay that measures 10 protein biomarkers associated with bladder cancer using easy-to-collect urine samples. Oncuria™ is currently being investigated to aid in the diagnosis of bladder cancer and to monitor people with early-stage bladder cancer for cancer recurrence. Additionally, the ability of the Oncuria assay and a proprietary algorithm that uses the 10-biomarker molecular signature is being investigated to predict whether patients with intermediate to high-risk early-stage bladder cancer will respond to bacillus Calmette-Guérin (BCG), a first-line treatment for bladder cancer, or whether they should proceed with other treatment options.
Oncuria received Breakthrough Device Designation from the US Food and Drug Administration (FDA) in September 2021 for predicting the response to BCG therapy. That designation acknowledges the utility and potential clinical benefit of Oncuria and allows for expedited review with the FDA.
For more information about Peregrine Market Access, visit www.peregrinemarketaccess.com. For more information about Nonagen Bioscience, visit www.nonagen.com.