OncoAssure Ltd, an Irish medical diagnostic company, today announced the publication of new data, in the British Journal of Urology International Compass (BJUI Compass), which demonstrates the clinical validation of OncoAssure Prostate, a novel biopsy test which provides improved estimation of a patient’s risk of prostate cancer recurrence and allows for optimal treatment selection.

Currently, the US is the major market for prognostic cancer tests, estimated to be worth in excess of $1billion for prostate cancer.

OncoAssure now plans to launch the OncoAssure Prostate test in the US market in Q1 2025 in collaboration with DiaCarta Inc. through DiaCarta’s ISO and CAP/CLIA Certified laboratory service, in Pleasanton, California.

Approximately 70% of prostate cancer patients have slow growing cancer and can safely leave their disease untreated while undergoing active surveillance; while 30% have an aggressive cancer with a high potential for recurrence, which requires treatment.

Current treatment approaches do not accurately identify whether a patient has aggressive or low-risk cancer; thus, over-treatment is a major issue as many patients undergo unwarranted radical treatments leading to severe complications including infection, incontinence, erectile dysfunction and depression.

The new study a collaboration by researchers from OncoAssure, University College Dublin, and Lund University, Sweden illustrates how OncoAssure Prostate, when tested on prostate cancer biopsy specimens, improves clinicians’ ability to estimate the likelihood of aggressive cancer compared to using standard clinical and pathological information.

The study demonstrated that integrating OncoAssure Prostate results with standard clinical and pathological information can substantially improve prognostic accuracy. Patients with higher OncoAssure Prostate risk scores were more likely to experience cancer recurrence, whereas men with lower risk scores were identified as suitable candidates for active surveillance.

"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."

Prostate cancer diagnosis and management often involves balancing the risks of aggressive disease with the potential side effects of treatment.

Des O’Leary, CEO and co-founder, OncoAssure, said, “By accurately identifying patients at higher risk of aggressive disease, our test equips clinicians to tailor treatment plans that can improve patient outcomes. 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.”

O’Leary added, “Furthermore, we have made significant progress in the development of our next product, a test for cutaneous melanoma and we have identified significant opportunities where unmet needs exist for new biomarkers in bladder, oesophageal, and squamous cell carcinoma. To fund the ongoing commercialisation of OncoAssure Prostate and continued development of novel cancer biomarkers, OncoAssure will be holding an investment round during 2025.”

OncoAssure was co-founded by Des O’Leary and Professor William Gallagher in 2021 and is headquartered at NovaUCD in Dublin.

The study was carried out with funding support from Research Ireland, OncoAssure Ltd, Swedish Cancer Society, and Swedish Scientific Council.

Paper reference: A. Krzyzanowska, D.F. Higgins, S. Barron et al., Clinical validation of a biopsy-based six-gene signature prognostic for aggressive prostate cancer, BJUI Compass, (December 2024). https://doi.org/10.1002/bco2.474