Irish medtech’s prostate diagnostics test set for US launch

21 Jan 2025

Des O'Leary. Image: Vincent Hoban, UCD

According to the American Cancer Society, about one in eight men in the US will be diagnosed with prostate cancer during their lifetime.

Irish medtech OncoAssure has published new data demonstrating the clinical validation of its biopsy test which provides an “improved estimation” of a patient’s risk of prostate cancer recurrence.

Now, on the heels of the study, the start-up plans to launch its test in the US market this quarter in collaboration with DiaCarta, a US-based precision diagnostics company, through its laboratory service in California.

Headquartered at NovaUCD in Dublin, OncoAssure was found in 2021 by Des O’Leary and Prof William Gallagher as a medical diagnostics company producing tests for cancer management.

In the study published in the British Journal of Urology International Compass last month, OncoAssure’s prostate test – a molecular clinical risk score – was found to predict risk for aggressive disease and cancer progression better than standard clinical and pathological information.

The study, which was authored by researchers from University College Dublin, Lund University in Sweden and OncoAssure’s founders, showcased that the start-up’s test, when integrated 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 those with lower risk scores were identified as suitable candidates for active surveillance, the company said.

The American Cancer Society says that about one in eight men in the US will be diagnosed with prostate cancer during their lifetime, and studies suggest that approximately 70pc of prostate cancer patients have slow-growing cancer and can safely leave their disease untreated while undergoing active surveillance, whereas 20-30pc have an aggressive cancer with a high potential for recurrence, requiring treatment.

According to the start-up, current treatment approaches do not accurately identify whether a patient has aggressive or low-risk cancer, leading to “over-treatment” which might cause severe complications including infection, incontinence, erectile dysfunction and depression.

“Our findings show that the OncoAssure Prostate test is a powerful tool that adds significant value to traditional clinical and pathological risk stratifiers,” said Gallagher, who is also OncoAssure’s chief scientific officer.

“This enables better-informed decisions for prostate cancer treatment, potentially reducing overtreatment and optimising outcomes.”

While O’Leary, the company’s CEO, 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.

“To fund the ongoing commercialisation of OncoAssure Prostate and continued development of novel cancer biomarkers, OncoAssure will be holding an investment round during 2025″.

Epicapture, a non-invasive cancer detection and monitoring start-up, created a prostate cancer detection test in 2023 that uses a patient’s urine to detect presence of the disease. The start-up was acquired by Trinity Biotech in October last year.

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Suhasini Srinivasaragavan is a sci-tech reporter for Silicon Republic

editorial@siliconrepublic.com