Tucson, AZ, April 12, 2017 Roche (SIX: RO, ROG; OTCQX:RHHBY) today 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.
To address this medical need, the p504s (SP116) Primary Antibody has been validated for use in a dual stain with VENTANA Basal Cell Cocktail (34ßE12+p63) to assist in distinguishing morphologically difficult cases as benign, atypical or cancerous on a single slide.
“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.
1Jiang, Z, Woda BA, Rock KL, et al. P504S: a new molecular marker for the detection of prostate carcinoma. Am. J. Surg. Pathol. 2001;25:1397-1404.
2This antibody is intended for in vitro diagnostic (IVD) use. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls.
3Globocan. Cancer Fact Sheets: Prostate Cancer. Globocan website. http://globocan.iarc.fr/old/FactSheets/cancers/prostate-new.asp
About the anti-p504s (SP116) Rabbit Monoclonal Primary Antibody
Anti-p504s (SP116) Rabbit Monoclonal Primary Antibody is identified for laboratory use in the detection of α-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.
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