OncoAssure spearheads breakthrough prostate cancer tech in US

The innovative OncoAssure Prostate Test provides urologists with advanced genomic insights to personalise prostate cancer treatment decisions, reducing overtreatment while improving patient outcomes.

UCD-based medtech OncoAssure has officially launched its next-generation prostate cancer prognostic test in the United States.

The company says this marks a significant advancement in precision oncology diagnostics. The announcement was made during the prestigious American Urological Association’s (AUA) 2025 Annual Meeting in Las Vegas, Nevada.

“This launch represents a major milestone in the commercialisation of the test in the US market”

OncoAssure’s Prostate Test represents a major breakthrough in prostate cancer diagnostics, offering physicians crucial genomic insights that help distinguish between aggressive and low-risk forms of prostate cancer.

This is a critical distinction that can prevent unnecessary treatments while ensuring appropriate intervention for high-risk cases.

Transforming prostate cancer care

This diagnostic tool integrates cutting-edge genomic technology with established clinical parameters to provide more accurate risk assessment at two critical decision points:

  • Post-biopsy: Helping determine whether active surveillance or immediate treatment is appropriate
  • Post-surgery: Assessing the risk of disease recurrence to guide adjuvant therapy decisions

“This launch represents a major milestone in the commercialisation of the test in the US market,” said Des O’Leary, CEO of OncoAssure. “Access to prognostic testing remains limited for many patients in the US, making the launch of OncoAssure Prostate especially timely.”

O’Leary added: “This test addresses a critical need by providing reliable information to distinguish between aggressive and low-risk forms of prostate cancer, helping to reduce overtreatment and improve patient outcomes.”

The future of cancer diagnostics

The OncoAssure Prostate Test was developed using the company’s proprietary OncoAssure Process. This innovative approach identifies a concise panel of upstream “Master Driver” genes that serve as reliable indicators of disease progression.

Importantly, the test incorporates the widely used CAPRA (Cancer of the Prostate Risk Assessment) score, allowing for seamless integration into current care pathways and making adoption straightforward for urologists.

The test will be commercially available through a partnership with DiaCarta Inc., which will provide testing services from its ISO and CAP/CLIA certified laboratory in Pleasanton, California.

Building on the successful launch of their prostate cancer test, OncoAssure is already making significant progress on its next product – a prognostic test for skin melanoma.

“Through the OncoAssure product development process we’ve successfully delivered our next-generation prognostic test,” O’Leary noted. “Building on this momentum, we’ve made strong progress in developing our next product, a prognostic test for skin melanoma.”

Founded in 2021 by Des O’Leary and Professor William Gallagher, OncoAssure is headquartered at NovaUCD in Dublin. The company plans to hold an investment round during 2025 to fund ongoing commercialisation of OncoAssure Prostate and continued development of novel cancer biomarkers.

Main image at top: Des O’Leary, CEO of OncoAssure

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