Roche, a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives, announced the global launch of the anti-p504s (SP116) Rabbit Monoclonal Primary Antibody for prostate cancer diagnosis. This antibody has been validated for use in a dual stain with the Ventana Basal Cell Cocktail (34ßE12+p63) to aid in distinguishing morphologically difficult cases as benign, atypical or cancerous on a single slide. The assay is an in vitro diagnostic (IVD) primary antibody for use on the Ventana BenchMark IHC/ISH series of automated slide stainers.

Elevated expression of p504s – also known as a-methylacyl-CoA racemase (AMACR) – has become a useful biomarker in the diagnosis of prostate adenocarcinoma When this biomarker is used in a dual stain with the Ventana Basal Cell Cocktail  (34ßE12+p63) it can reduce the need for multiple slides to make a diagnosis. This can be critical when limited tissue sample is available, as is often the case with prostate biopsies.

"As the second most common cancer in men, prostate cancer is a serious public health concern," said Ann Costello, head of Roche Tissue Diagnostics. "The anti-p504s (SP116) Primary Antibody is an important tool to aid clinicians in making a more accurate diagnosis with a smaller tissue sample."

An estimated 1.1 million men worldwide were diagnosed with prostate cancer in 2012, accounting for 15 per cent of all cancers diagnosed in men. The anti-p504s (SP116) Rabbit Monoclonal Primary Antibody enhances the Roche prostate portfolio of key assays used to diagnose prostate cancer.

Anti-p504s (SP116) Rabbit Monoclonal Primary Antibody is intended for laboratory use in the detection of a-methylacyl-CoA racemase (AMACR) in sections of formalin-fixed, paraffin-embedded (FFPE) tissue. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls. This antibody is intended for in vitro diagnostic (IVD) use.