Almac's Prostate Cancer Metastatic Assay validation published


Additional manuscripts are being prepared including one to show the assay can be transferred to several commercial platforms

The Journal of European Urology has published results relating to Almac's Prostate Cancer Metastatic Assay.

The publication demonstrates the assay can be used to analyse primary prostate cancer FFPE samples to identify a molecular subgroup with a high risk of developing distant metastases. The assay therefore has the potential to guide the choice of therapy for patients presenting with primary prostate cancer.

An unbiased discovery approach was used to identify a molecular subtype of primary prostate cancer that demonstrated metastatic biology.

Richard Kennedy is Vice President and Medical Director of Almac Diagnostics and McClay Professor in Medical Oncology at Queen’s University Belfast.

He said: “This approach has created a very robust assay with excellent performance, independent of clinical factors such as Gleason and CAPRA. We believe it will play a significant role in aiding clinicians to select the most appropriate therapy regimen for their patients.”

Independent assay validation was performed using 322 radical prostatectomy samples with Metastatic Assay positive patients having increased risk of biochemical recurrence and metastatic recurrence.

A combined model with CAPRA-S identified patients at increased risk of biochemical and metastatic recurrence superior to either model alone.

“The publication of this manuscript in a journal of this calibre represents a significant milestone in the assay’s development,” said Paul Harkin, President and Managing Director, Almac Diagnostics.

Two additional manuscripts are being prepared for submission; another clinical validation using biopsy FFPE tissue and an analytical validation to demonstrate the assay can be transferred to several commercial platforms.

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The study was conducted in conjunction with The Movember / Prostate Cancer UK funded Prostate Cancer Centre of Excellence at Queen’s University of Belfast and Manchester University along with Cardiff University, University College Dublin, Oslo University and the University of Surrey.