Roche Launches Antibody Test to Aid in Diagnosis of Challenging Prostate Cancer Cases

Roche has announced the global launch of the anti-p504s (SP116) Rabbit Monoclonal Primary Antibody2 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 α-methylacyl-CoA racemase (AMACR) – has become a useful biomarker in the diagnosis of prostate adenocarcinoma1. 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 percent of all cancers diagnosed in men3. The anti-p504s (SP116) Rabbit Monoclonal Primary Antibody enhances the Roche prostate portfolio of key assays used to diagnose prostate cancer.