Roche has won what it claims is the first major public tender in Europe for use of its HPV test in primary cervical cancer screening. The firm has been awarded an exclusive contract by Karolinska University Hospital in Stockholm, Sweden, to provide its PCR-based cobas HPV test for high-risk virus types. The screening program will start in November and is expected to serve as a pilot for implementing HPV primary screening nationwide in Sweden.
The qualitative cobas HPV Test is designed to detect 14 high-risk HPV types, including HPV 16 and 18, which are responsible for over 70% of cervical cancers, Roche maintains. The Swedish program is one of the first to follow 2008 EU guidelines for cervical screening, which for the first time included the use of HPV testing as a primary diagnostic assay, as long as implementation was piloted with stringent evaluation.
The firm maintains that HPV testing, and evaluation for genotypes 16 and 18 in particular, can identify more women at risk of cervical cancer than Pap cytology testing alone. “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 precancerous lesions,” comments Daniel O’Day, CEO at Roche Diagnostics. “With the introduction of our new HPV test as a primary screening test, we hope to reduce the number of women who are missed in the early stages.”