Health Canada Approves Roche's HPV Test for First-Line Primary Screening of Cervical Cancer
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 ScreeningLAVAL, 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.