VENTANA ALK (D5F3) CDx Assay

 

Media Release

Roche launches antibody test to aid in diagnosis of challenging prostate cancer cases

  • Prostate cancer accounts for 15 percent of all cancers diagnosed in men3
  • Elevated expression of p504s has become a useful biomarker in the diagnosis of prostate adenocarcinoma1
  • Roche’s anti-p504s (SP116) Primary Antibody is an important tool to aid clinicians in making a more accurate diagnosis with a smaller tissue sample

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.

About RocheRoche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

Print:

Prostate carcinoma stained with the anti-p504s (SP116) Rabbit Monoclonal Primary Antibody.

Media Relations

Gabrielle Fimbres
Sr. Manager of External Communications
Phone: 520.222.4573
gabrielle.fimbres@roche.com

For Roche media inquiries, visit Roche media relations.