Roche Diagnostics responds to HPV announcement

Roche Diagnostics welcomes the announcement by Public Health Minister, Jane Ellison, to introduce Human Papillomavirus (HPV) primary screening in England.

Brigitte Fernandes-McAlear, Director, Roche Molecular Solutions said “This is truly exciting news and will transform cervical cancer testing, saving many more lives.

“DNA based HPV testing has been at the heart of our research for over 10 years. Through our landmark ATHENA study Roche Diagnostics not only validated the cobas HPV test, but also demonstrated the long-term safety of using HPV DNA as a predictor of cervical cancer risk.

“To see HPV primary screening given prominence alongside existing testing, is therefore a landmark moment for patients. We look forward to working with the NHS screening programme to help identify those women most at risk of developing cervical cancer, and will be working with laboratories across the country to support the implementation of this new test.”

Notes

About the cobas HPV Test and cobas 4800 System from Roche Molecular Solutions

Clinically validated by the landmark ATHENA trial, the cobas HPV Test is the only FDA-approved HPV assay that provides specific genotyping information for HPV 16 and 18, the highest-risk types, while simultaneously reporting the 12 other high-risk HPV types as a pooled result, all in one run, from one patient sample. In April 2014, the FDA approved the cobas® HPV Test as a first-line primary screening test for cervical cancer in women 25 and older. It is now the only assay approved for the following indications: ASCUS reflex, co-testing, and primary screening.

The test is performed on the cobas 4800 System, which offers true walk-away automation of nucleic acid purification, PCR (polymerase chain reaction) set-up and real-time PCR amplification and detection to help laboratories achieve maximum efficiency. The system also runs the cobas 4800 CT/NG Test (chlamydia/gonorrhea), cobas Cdiff Test, cobas MRSA/SA Test, cobas HSV1 and 2 Test, and the cobas BRAF V600 Mutation Test, cobas EGFR Mutation Test and cobas KRAS Mutation Test.

For more information on the cobas® HPV Test, please visit www.hpv16and18.com

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-four 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 roche.com.

All trademarks used or mentioned in this release are protected by law.

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