Innogenetics has announced its entry into the field of HPV diagnostic testing, in line with its diagnostics growth strategy.
The announcement coincides with the important 23rd International Papillomavirus Congress and Clinical Workshop in Prague, gathering specialists in the field of HPV diagnostics and therapeutics. Infection with HPV genotypes 16 and 18, amongst others, is strongly associated with the development of cervical cancer, the second most common cause of cancer-related deaths in women worldwide. These genotypes are also present in the recently developed HPV prophylactic vaccines and are all detectable with Innogenetics HPV genotyping product.
The new assay, the INNO-LiPA HPV Genotyping CE, is expected to obtain formal CE-marking* in early autumn.
Human papillomavirus infection is strongly related to the development of cervical cancer. At present, women are screened preventively for sign of the disease or its onset by Pap smear testing. While the virus can occur in a variety of different related types, it has been demonstrated that genotypes 16 and 18 account for approximately 70% of cervical cancers.
In the US alone, approximately 10,000 cervical cancers are detected annually. In addition, genotypes 6 and 11 are found in approximately 90% of genital warts. The link between particular HPV genotypes and medical conditions led to the development and recent approval of prophylactic HPV vaccines targeted at the above-mentioned HPV genotypes.
The new HPV diagnostic test developed by Innogenetics encompasses the most important HPV genotypes, including the genotypes 6, 11, 16, and 18 that are present in the recently approved and most advanced prophylactic vaccines. The INNO-LiPA HPV Genotyping CE test will provide an important complement to Pap smear testing, and current DNA-based HPV screening tests. Furthermore, the test will prove useful in the selection of individuals eligible for preventive HPV vaccination, and their follow-up. Formal CE-marking of the INNO-LiPA HPV Genotyping CE is expected before the end of October.