In 2008, European Union guidelines for cervical screening introduced the alternative possibility to use HPV testing as the primary diagnostic test, provided that implementation was piloted in an organised fashion with stringent evaluation. The Swedish program is one of the first to follow these guidelines.
"Roche is committed to providing healthcare solutions that can positively impact the lives of many women. We have shown in clinical trials that one out of ten women with normal Pap who have HPV genotype 16 and/or 18 already had pre-cancerous lesions. These women may have been sent home without follow up if tested with traditional Pap alone," said Daniel O'Day, Chief Operating Officer of Roche Diagnostics. "With the introduction of our new HPV test as the primary screening test, we hope to reduce the number of women who are missed in the early stages and thereby enable earlier intervention before they develop cervical cancer."
Screening has traditionally been performed using either Pap cytology or Pap cytology plus HPV testing to determine the risk of cervical cancer. However, HPV testing, and 16 and 18 genotyping in particular, identifies more women at risk earlier than Pap cytology testing alone. HPV genotypes 16 and 18 are the two highest-risk HPV genotypes responsible for more than 70 percent of cervical cancer cases.
The Karolinska University Hospital is one of the largest and most prestigious hospitals in Sweden and performs all testing for the organised cervical screening program in Stockholm.
About Human Papillomavirus
Persistent infection with Human Papillomavirus is the principal cause of cervical cancer in women, with HPV implicated in greater than 99 percent of cervical cancers worldwide. According to the National Board of Health and Welfare there are 450 new cases of cervical cancer in Sweden annually and 150 deaths due to the disease. The World Health Organisation estimates there are 470,000 new cases of cervical cancer annually.
About the cobas HPV Test and cobas 4800 System
The cobas HPV Test is a qualitative in-vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV 16 and HPV 18 while concurrently detecting the other high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). It is available in the US and all countries accepting a CE mark.
The cobas 4800 System is designed to deliver new standards in laboratory testing efficiency and medically relevant diagnostic information. The system offers true walk-away automation and can run up to 282 tests in less than 12 hours, providing rapid analysis of screening tests for HPV infections meeting the needs of the majority of clinical labs.
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, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80’000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan.