Health Canada Approves Roche's HPV Test for First-Line Primary Screening of Cervical Cancer and Roche Launches New Cytology Test to Provide the Most Comprehensive Portfolio for Cervical Cancer Screening

LAVAL, QC, June 10, 2014 /CNW Telbec/ - Roche announced that Health Canada approved the cobas® 4800 HPV (Human Papillomavirus) Test for use as a first-line primary screening test for cervical cancer in women 25 and older. Roche has also launched the fully automated CINtec® PLUS test to improve the detection and early intervention of pre-cancerous cervical disease. The Health Canada approved CINtec® PLUS cytology test helps identify women with high-grade pre-cancerous cervical lesions who need immediate colposcopy. Roche's portfolio of cervical cancer screening products provides the most comprehensive strategies for cervical cancer prevention and treatment. 

"We are very pleased that Health Canada has approved the cobas® 4800 HPV test for use as a first-line primary screening test to identify women at increased risk for the development of cervical cancer", said Ian Parfrement, President & General Manager, Roche Diagnostics Canada. "We will partner with healthcare professionals and authorities to redefine and adapt current practice guidelines to encourage clinicians to incorporate these new tests in their patient protocols. If caught early, cervical cancer is one of the most preventable and curable cancers with a survival rate of more than 90% and with our Cervical Cancer Screening solution we will certainly improve patient care and people's health."

"Canada has always been on the forefront of innovative strategies in cervical cancer prevention," said Dr. Eduardo Franco, James McGill Professor and Chair, Department of Oncology, Director, Division of Cancer Epidemiology, McGill University. "Once again, Canadian women will benefit from a major technological innovation, with the recent approval by Health Canada of the first molecular test with genotyping 16 & 18 for general cervical cancer screening. The new indication will give women more safety while reducing their dependence on frequent screening visits."

The cobas® 4800 HPV Test provides both pooled high-risk HPV DNA results and individual detection of HPV 16 and HPV 18, the two types responsible for about 70 percent of cervical cancer. Health Canada's decision to approve the expanded use for the cobas® 4800 HPV Test was based on results from the landmark ATHENA trial, which enrolled more than 47,000 women. The study demonstrated that one in four women who are HPV 16 positive will have cervical disease within three years and that nearly 1 in 7 women with normal Pap cytology who were HPV 16 positive actually had high-grade cervical disease that was missed by cytology.

In addition, results from the ATHENA trial included a comparison of a cobas® 4800 HPV Test screening strategy to alternative strategies using Pap cytology and HPV testing. The comparison showed that a strategy leveraging the ability of the cobas® 4800 HPV Test to identify women testing positive for HPV 16 or 18, and using cervical cytology as a triage, follow-up test, would allow clinicians to detect more disease without referring a significant number of women to unnecessary follow-up.

About Human Papillomavirus and Cervical Cancer
Human papillomavirus (HPV) infections are common and cause almost all cervical cancer. However, only those women with persistent HPV infections and who have developed high-grade pre-cancerous cervical disease should be treated. More than 500,000 new cases of cervical cancer are diagnosed each year worldwide and half of these patients die.¹ Cervical cancer is preventable through routine screening where women with pre-cancerous lesions can be treated before cancer develops. Unfortunately, the average five-year survival rate of patients is around 20% if the disease has advanced at the time of the diagnosis.

About the Roche Cervical Cancer Screening Portfolio
The cobas® 4800 HPV Test screens for all high-risk genotypes together while simultaneously identifying those women who are genotype 16 and/or 18 positive that would benefit from immediate intervention. The CINtec® PLUS helps identify underlying disease, determining those who should proceed to colposcopy. The CINtec® histology test confirms the presence or absence of CIN2+ lesions (p16-positive) in biopsies obtained during colposcopies.

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 Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy. In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 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. Founded in 1931, Roche Canada employs approximately 900 people across the country, with its pharmaceuticals head office located in Mississauga, Ontario and its diagnostics division based in Laval, Quebec. Roche Canada is actively involved in local communities, investing in charitable organizations and partnering with healthcare institutions across the country. For more information, visit www.rochecanada.com.

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References
¹World Health Organization Fact Sheet 380, September 2013: http://www.who.int/mediacentre/factsheets/fs380/en/ 

SOURCE: Roche Diagnostics

For further information: Mélanie Lussier, Communications, Roche Diagnostics Canada, Tel. : [phone], [e-mail]