Roche gains CE label expansion for companion diagnostic to identify ALK-positive non-small cell lung cancer patients

Tucson, Arizona

July 25, 2017 
 

• Lung cancer remains the leading cause of cancer deaths, with 1.6 million deaths worldwide each year.¹
• ALK – anaplastic lymphoma kinase – is an important biomarker found in non-small cell lung cancer (NSCLC). Its detection and inhibition can help shrink tumours in some ALK-positive patients.
• The VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody² identifies ALK-positive NSCLC patients eligible for treatment with ZYKADIA^® (ceritinib).
   

Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced that it has obtained a CE mark for the VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with the Novartis drug ZYKADIA (ceritinib). The VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody is the only immunohistochemistry (IHC) test CE marked as a companion diagnostic for ZYKADIA.

Precise, personalised diagnostics are critical as we continue the fight against non-small cell lung cancer, said Ann Costello, Head of Roche Tissue Diagnostics. Expanded use of the VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody to identify non-small cell lung cancer patients with an ALK-positive mutation allows us to aid clinicians and their patients in identifying appropriate treatment options.

The VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody is available for use on BenchMark IHC/ISH instruments.

About the VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody

VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody (VENTANA anti-ALK (D5F3)) is intended for laboratory use in the detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded non-small cell lung carcinoma (NSCLC) tissue stained with the BenchMark series immunohistochemical automated slide stainers. It is indicated as an aid in identifying patients eligible for treatment with ZYKADIA^® (ceritinib) or XALKORI^® (crizotinib).

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 ZYKADIA

For more information on ZYKADIA (ceritinib), visit www.novartisoncology.com/news/product-portfolio/zykadia

About Roche

Roche 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. Thirty medicines developed by Roche are included in the World Health Organisation 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.

VENTANA and BENCHMARK are trademarks of Roche. ZYKADIA is a trademark of Novartis. Other product names and trademarks are the property of their respective owners.