New automated CINtec PLUS test improves the detection of cervical pre-cancer
Basel, 21 February 2014 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of the fully automated CINtec PLUS* cytology test to improve the detection and early intervention of pre-cancerous cervical disease. The CINtec PLUS cytology test helps identify women with high-grade pre-cancerous cervical lesions who need immediate colposcopy.
“Cervical cancer is the third most common cancer in women worldwide and there are often no symptoms associated with cervical pre-cancer. With the launch of the fully automated CINtec PLUS Cytology Kit, Roche has the most comprehensive cervical cancer screening portfolio in the industry, helping to protect women from cervical cancer and from overtreatment,” said Roland Diggelmann, COO Division Roche Diagnostics. “The comprehensive portfolio shows our strong commitment to advancing women’s health and setting new healthcare standards.”
Human papillomavirus (HPV) infections are common and cause almost all cervical cancer.1 However, only those women with persistent HPV infections and who have developed high-grade pre-cancerous cervical disease should be treated. The CINtec PLUS cytology test was developed to help identify those HPV infections that may lead to cancer and distinguish them from those that will not. When compared with Pap smear, the CINtec PLUS cytology test is significantly more effective in detecting cervical pre-cancer.2
More than 500,000 new cases of cervical cancer are diagnosed each year worldwide and half of these patients die.1Cervical cancer is preventable through routine screening where women with pre-cancerous lesions can be treated before cancer develops. If caught early, cervical cancer is one of the most preventable and curable cancers with a survival rate of more than 90%. Unfortunately, the average five-year survival rate of patients is around 20% if the disease has advanced at the time of the diagnosis.
The fully automated CINtec PLUS cytology test is available in Europe, Asia, Latin America and Canada.
About the Roche cervical cancer screening portfolio
The cobas 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 cytology test helps identify underlying disease, determining those who should proceed to colposcopy.
About the landmark Primary ASC-US LSIL Marker Study
In several large European studies, including the landmark Primary ASC-US LSIL Marker Study (PALMS)2 of more than 27,000 women, the Roche CINtec PLUS cytology test, when compared to Pap cytology testing, was more effective in detecting precancerous cervical lesions. In screening, Pap cytology had a sensitivity of 68.5% while the CINtec PLUS test had a sensitivity of 86.7%.
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 WHO 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. For more information, please visit www.roche.com.
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* The CINtec PLUS Cytology Kit is not available in all geographies and/or may not be approved for all uses discussed in this press release. It is currently not available for use in the United States.
1) World Health Organization Fact Sheet 380, September 2013: http://www.who.int/mediacentre/factsheets/fs380/en/
2) Ikenberg et al., J Natl Cancer Inst; 2013; 105: 1550-1557.