Novel Biopsy Test Accurately Assesses Risk of Aggressive Disease in Early-Stage Prostate Cancer Patients

Prostate cancer ranks as the second most common cancer in men, the second leading cause of cancer-related deaths in men, and the fourth most prevalent cancer worldwide. Diagnosing and managing prostate cancer often involves weighing the risks of aggressive disease against the potential side effects of treatment. Around 70% of prostate cancer cases are slow-growing and can be safely monitored with active surveillance, while 30% are more aggressive and require immediate treatment due to their high potential for recurrence. However, current diagnostic methods struggle to accurately distinguish between aggressive and low-risk cancer, leading to over-treatment. Many patients undergo unnecessary radical treatments, which can result in severe complications such as infections, incontinence, erectile dysfunction, and depression. A new biopsy test now offers improved risk assessment for prostate cancer recurrence, allowing for more informed treatment decisions.

OncoAssure Ltd. (Dublin, Ireland) has developed OncoAssure Prostate, a biopsy-based molecular test that helps identify patients with low-risk prostate cancer who can be safely managed with active surveillance, avoiding the significant lifelong side effects associated with more aggressive treatments. The test has been developed and optimized using a large, multi-center cohort and clinically validated in two independent international cohorts. A collaborative study showed that OncoAssure Prostate improves clinicians’ ability to predict aggressive cancer compared to using standard clinical and pathological data alone.

The study, published in BJUI Compass, demonstrated that incorporating OncoAssure Prostate results alongside traditional clinical and pathological information significantly enhances prognostic accuracy. Patients with higher OncoAssure Prostate risk scores were more likely to experience cancer recurrence, while those with lower risk scores were identified as suitable candidates for active surveillance. This prognostic test, which can accurately differentiate between aggressive and low-risk prostate cancers at the initial diagnosis, helps identify high-risk patients (about 20%) who would benefit from more intensive treatment, while providing low-risk patients with the reassurance that active surveillance is the best option for them.

"Our findings show that the OncoAssure Prostate test is a powerful tool that adds significant value to traditional clinical and pathological risk stratifiers," said Professor William Gallagher, Chief Scientific Officer, and co-founder, OncoAssure. "This enables better-informed decisions for prostate cancer treatment, potentially reducing overtreatment and optimizing outcomes."

“By accurately identifying patients at higher risk of aggressive disease, our test equips clinicians to tailor treatment plans that can improve patient outcomes,” added Des O’Leary, CEO and co-founder, OncoAssure. “OncoAssure Prostate is now validated for use at two key decision points along the Prostate Cancer pathway, namely post-biopsy and post-radical prostatectomy. This new data underpins the value of the test as we launch the product in the US this year.”

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OncoAssure Ltd.