Almac Group’s Diagnostics business unit has announced the Journal of European Urology has published results relating to its 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.
Professor Richard Kennedy, MD, PhD, VP and Medical Director, Almac Diagnostics and McClay Professor in Medical Oncology, Queen’s University Belfast commented “An unbiased discovery approach was used to identify a molecular subtype of primary prostate cancer that demonstrated metastatic biology. 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.”
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. Independent assay validation was performed using 322 radical prostatectomy samples with Metastatic Assay positive patients having increased risk of biochemical recurrence (Multivariable HR 1.62; p= 0.0092) and metastatic recurrence (Multivariable HR=3.20; p=0.0001). A combined model with CAPRA-S identified patients at increased risk of biochemical and metastatic recurrence superior to either model alone (HR=2.67; p<0.0001 and HR=7.53; p<0.0001) respectively. “The publication of this manuscript in a journal of this calibre represents a significant milestone in the assay’s development and with two additional manuscripts being prepared for submission, further milestones are expected to be reached later this year. The first is another clinical validation but this time using biopsy FFPE tissue and the second is analytical validation to demonstrate the assay can be transferred to several commercial platforms.” said Professor Paul Harkin, President and Managing Director, Almac Diagnostics. He went on to say “Almac has been at the forefront of RNA based genomic innovation for over 10 years and this assay represents just one of our innovative pipeline of predictive and prognostic tests”.