Media Release

Basel, 22 July 2015

Roche Diagnostics strengthens its blood screening portfolio with an assay to identify Human T-lymphotropic virus I/II (HTLV-I/II) infection to increase blood safety

New test for the Roche serology assay portfolio helps specialists to identify HTLV-I/II infection in donated blood and diagnostic samples

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the market availability* of the Elecsys® HTLV-I/II immunoassay, a diagnostic test to help detect antibodies against Human T-lymphotropic virus I or II infection in donated blood and routine diagnostic samples. Designed for the needs of blood centres and clinical laboratories for reliable and efficient detection of this infection, the test enhances Roche’s blood screening portfolio in serology testing. This test complements the most comprehensive diagnostics offering for blood safety solutions available on the market today.

“Globally there are around 20 million people infected with HTLV-I/II, many of whom are unknown carriers. If the virus is undetected in donors, the risk of spreading the infection increases,” said Roland Diggelmann, Chief Operating Officer of the Roche Diagnostics Division. “Roche is uniquely positioned to help blood centers improve their testing efficiency, based on our broad assay portfolio and integrated molecular and serology laboratory solutions .“

Thanks to its excellent sensitivity, the test minimizes the likelihood of missing early or chronic HTLV infections, therefore, reducing the risk of transmission. Its high specificity facilitates a clear and consistent interpretation of results at all disease stages with a minimal need for re-testing, providing maximum efficiency gains for the laboratory and patient safety. Moreover, the efficient test procedure enables healthcare professionals to run a single test within 18 minutes, ensuring the safe and timely supply of blood products.

About HTLV-I/II

The human T-lymphotropic viruses (HTLV) type I and II are retroviruses that have infected approximately 20 million people worldwide. They can be transmitted from mother to child via breastfeeding, through hetero- or homosexual intercourse, sharing contaminated needles, or via contaminated blood products.

HTLV-I is the more clinically relevant of the two viruses and has been directly associated with the life-threatening disease adult T-cell leukemia/lymphoma (ATLL) and the life-debilitating condition HTLV-associated myelopathy/tropical spastic paraparesis (HAM/TSP). An HTLV infection persists lifelong and there is currently no treatment to eliminate the virus from the body.

About Roche Diagnostics in infectious disease

Roche has a heritage of more than 30 years in providing diagnostic solutions for infectious diseases, and the assays for blood screening use technologies specifically developed for the company’s serology and nucleic acid testing platforms. Since their launch in 1996, more than a hundred high-quality Elecsys assays for immune testing have been developed, not to mention a new generation of fully automated cobas analyzers for improved medical decision making, scheduling and efficiency.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. 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 chemotherapy.

In 2014, the Roche Group employed 88,500 people worldwide, invested 8.9 billion Swiss francs in R&D and posted sales of 47.5 billion Swiss francs. 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.

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*CE-mark; local product availability may vary independently from CE Mark approval.