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FDA Approves Roche’s Companion Diagnostic to Identify ALK-Positive NSCLC Patients

Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced US Food and Drug Administration (FDA) approval of the VENTANA ALK (D5F3) CDx Assay 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 ALK (D5F3) Assay is the only immunohistochemistry (IHC) test approved by the FDA as a companion diagnostic for ZYKADIA.

Lung cancer remains the leading cause of cancer deaths, with more than 1.6 million deaths worldwide each year.1

“With the FDA’s approval of the expanded use of the VENTANA ALK (D5F3) CDx Assay to determine which lung cancer patients are eligible for ZYKADIA, we are helping clinicians and their patients identify additional treatment options for non-small cell lung cancer,” said Ann Costello, Head of Roche Tissue Diagnostics. “This is another example of Roche’s continued commitment to advancing the standard of care for lung cancer patients and personalized medicine.”

The VENTANA ALK (D5F3) CDx Assay is available for use on BenchMark IHC/ISH instruments.

About the VENTANA ALK (D5F3) CDx Assay

VENTANA ALK (D5F3) CDx Assay is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with a BenchMark XT or BenchMark ULTRA automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib) or ZYKADIA® (ceritinib).

This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls.

This product is intended for in vitro diagnostic (IVD) use. For more information, visit ALKIHC.com.

About ZYKADIA

For more information on ZYKADIA (ceritinib), visit www.hcp.novartis.com/products/zykadia/alk-nsclc/

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. 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.

VENTANA and BENCHMARK are trademarks of Roche. Other product names and trademarks are the property of their respective owners.

1World Health Organization

2This product is intended for in vitro diagnostic (IVD) use.

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