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Successful Validation and Approval of the PapilloCheck HPV Test

Published: Wednesday, May 22, 2013
Last Updated: Wednesday, May 22, 2013
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The PapilloCheck HPV test from Greiner Bio-One GmbH has now received approval from the Dutch Society for Pathology.

Cervical cancer is one of the most frequent cancers among women. It is caused by a persistent infection involving certain types of human papillomaviruses (HPV). If this infection is detected at an early stage and the patient is given appropriate medical treatment, the development of cervical cancer can be prevented in virtually all cases. HPV tests, which detect the carcinogenic virus, therefore play a major role in cervical cancer screening.

Only HPV tests with a well-documented clinical performance and reproducibility should be used in the clinical management of cervical cancer. This is why guidelines such as those defined by a group of international experts led by Chris Meijer from the Free University of Amsterdam are essential. These guidelines describe the requirements for HPV-DNA tests and must be fulfilled by test providers.

The PapilloCheck HPV-DNA test from Greiner Bio-One enables the reliable detection and identification of 24 virus types (typing), thus ensuring realistic risk assessment for the patient. Its capabilities have already been demonstrated in several clinical studies. Two studies have now been conducted to evaluate the performance evaluation in terms of clinical sensitivity and specificity as well as inter- and intra-reproducibility in accordance with the specifications of international guidelines.

PapilloCheck met all the criteria that HPV tests need to fulfil for clinical use. In early 2013, the Dutch Society for Pathology followed this evaluation and granted PapilloCheck its approval. This is a milestone in performance evaluation of PapilloCheck and ultimately leads to safety for patients.

PapilloCheck® is part of the oCheck® product line from Greiner Bio-One GmbH.

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