SARATOGA SPRINGS, NY and LOS ANGELES, January 27, 2022 /PRNewswire/ — Peregrine Market Access, a leading life sciences commercialization partner, has been selected by Nonagen Bioscience to become its contract commercialization organization for Oncuria™, a breakthrough diagnostic test for prostate cancer. developing bladder to aid disease detection, therapy selection, and monitoring. As part of a multi-year, multi-million dollar agreement, Peregrine Market Access will lead United States launch of Oncuria™.
“After an extensive search for the right commercialization partner, we are confident that Peregrine Market Access is the optimal choice to help us successfully commercialize Oncuria™,” says CEO of Nonagen Bioscience. Charles Joel Rosser, MD, MBA. “John Guarino and its world-class team not only have the experience and expertise to help us navigate the complexities of launching a new device in United Statesbut they also share our passion for improving the lives of people with life-threatening chronic conditions.”
Nonagen Bioscience’s Oncuria™ is an advanced multiplex immunoassay that measures 10 protein biomarkers associated with bladder cancer using easily collected urine samples. Oncuria™ is currently being studied 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™ test 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. Bacillus Calmette-Guérin (BCG), a first-line treatment for bladder cancer, or if they need to continue with other treatment options. Oncuria™ received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in September 2021 to predict response to BCG therapy. This designation recognizes the utility and potential clinical benefits of Oncuria™ and allows for expedited review with the FDA.
“We are excited to become an extension of the Nonagen Bioscience team to advance a breakthrough immunoassay in the fight against bladder cancer,” says John Guarino, President and Founder of Peregrine Market Access. “This partnership with Nonagen Bioscience will allow Peregrine to showcase the breadth and depth of our capabilities and, more importantly, contribute to the noble work of saving lives through rapid response.
Nonagen Bioscience aims to provide physicians and patients with an effective diagnostic tool to improve clinical outcomes and reduce healthcare costs. The statistics surrounding bladder cancer demonstrate the unmet needs that exist: each year, an estimated 84,000 new cases of bladder cancer occur.
diagnosed and over 700,000 people living with bladder cancer United States.1 It is the fourth most common form of cancer in American men.2 Up to 77% of early-stage bladder tumors treated with current approaches (tumor resection and/or intravesical BCG or chemotherapy) recur.3 More than half of patients who receive BCG as first-line treatment for bladder cancer will not respond, and in 20% of patients the disease develops and spreads during or after BCG treatment.4.5
ABOUT PEREGRINE MARKET ACCESS
Peregrine Market Access is a full-service marketing partner for the life sciences industry with capabilities in the consulting, communications and execution phases of market access and brand campaigns. Peregrine’s business units include Strategy and Consulting, Market Access Communications, Research and Analytics, Value Modeling, Reimbursement Solutions, Value Stream Public Relations, media and contract account and sales team services. Through its work, Peregrine helps people living with chronic and/or life-threatening illnesses access FDA-approved diagnostics and treatments. Peregrine, which is on a mission to change the way healthcare is valued by United Stateswas nationally recognized as one of America’s fastest growing private companies in 2021 in Inc. 5000. The company is headquartered in Saratoga Springs, NYand also has an office Santa Monica, California. Learn more about PeregrineMarketAccess.com.
ABOUT NONAGEN BIOSCIENCE
Nonagen Bioscience is an early-stage biotechnology company focused on reducing the global burden of cancer through innovative diagnostics. The Los Angeles-based company is committed to bringing to market the best non-invasive diagnostics for cancer detection, therapy selection and disease monitoring. Learn more about Nonagen.com.
The references: 1. National Cancer Institute. Statistical Cancer Facts: Bladder Cancer. Accessed January 11, 2022. seer.cancer.gov/statfacts/html/urinb.html 2. American Cancer Society. Cancer facts and figures 2021. Atlanta, Georgia: American Cancer Society; 2021. 3. Ritch CR, Velasquez MC, Kwon D, et al. Use and validation of the AUA/SUO risk group for non-muscle invasive bladder cancer in a contemporary cohort. J Urol. 2020;203(3):505-511. doi:10.1097/JU.0000000000000593 4. Witjes JA. Management of BCG failures in superficial bladder cancer: a review. Euro Urol. 2006;49(5):790-797. doi:10.1016/j.eururo.2006.01.017 5. Matulay JT, Li R, Hensley PJ, et al. Contemporary outcomes of patients with non-muscle invasive bladder cancer treated with Bacille Calmette-Guérin: implications for clinical trial design. J Urol. 2021;205(6):1612-1621. doi:10.1097/JU.0000000000001633
SOURCE Peregrine Market Access