SARATOGA SPRINGS, N.Y. and LOS ANGELES, Jan. 27, 2022 /PRNewswire/ -- 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™.
"After an extensive search for the right commercialization partner, we are confident that Peregrine Market Access is the optimal choice to help us succeed in bringing Oncuria™ to market," explains Nonagen Bioscience CEO Charles Joel Rosser, MD, MBA. "John Guarino and his world-class team not only have the experience and expertise to help us navigate the complexities of launching a novel device in the United States, but they also share our passion to improve the lives of people living with chronic, life-threatening conditions."
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.
"We are excited to become an extension of the team at Nonagen Bioscience to advance a game-changing immunoassay in the fight against bladder cancer," says John Guarino, president and founder of Peregrine Market Access. "This partnership with Nonagen Bioscience will enable Peregrine to showcase the breadth and depth of our capabilities and, most importantly, to contribute to the noble work of saving people's lives through timely intervention."
Nonagen Bioscience aims to give physicians and patients 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, there are an estimated 84,000 new cases of bladder cancer diagnosed and more than 700,000 people living with bladder cancer in the 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) will recur.3 More than half of patients who receive BCG as the first-line treatment for bladder cancer will fail to respond, and in 20% of patients the disease grows and extends during or after BCG treatment.4,5
ABOUT PEREGRINE MARKET ACCESS
Peregrine Market Access is a full-service commercialization partner to the life science industry with capabilities in consulting, communication, 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 Chain Public Relations, Media Mapping, and Contract Account and Sales Team services. Through its work, Peregrine helps people living with chronic and/or life-threatening conditions to gain access to FDA-approved diagnostics and treatments. Peregrine, which is on a mission to change the way healthcare is valued in the United States, earned national recognition as one of America's fastest-growing private companies in 2021 by Inc. 5000. The company is headquartered in Saratoga Springs, New York, and also has an office in Santa Monica, California. Learn more at PeregrineMarketAccess.com.
ABOUT NONAGEN BIOSCIENCE
Nonagen Bioscience is an early-stage biotechnology company focused on globally reducing the burden of cancer with innovative diagnostics. The Los Angeles–based company is committed to bringing to the market best-in-class, non-invasive diagnostics for cancer detection, therapy choice, and disease monitoring. Learn more at Nonagen.com.
References: 1. National Cancer Institute. Cancer Stat Facts: Bladder Cancer. Accessed January 11, 2022. seer.cancer.gov/statfacts/html/urinb.html 2. American Cancer Society. Cancer Facts & Figures 2021. Atlanta, GA: American Cancer Society; 2021. 3. Ritch CR, Velasquez MC, Kwon D, et al. Use and validation of the AUA/SUO risk grouping for nonmuscle 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. Eur 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 nonmuscle-invasive bladder cancer treated with bacillus Calmette-Guérin: implications for clinical trial design. J Urol. 2021;205(6):1612-1621. doi:10.1097/JU.0000000000001633
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SOURCE Peregrine Market Access
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