At MEDICA 2010 in Dusseldorf, Greiner Bio-One GmbH is unveiling the new PapilloCheck high-risk test system to augment the existing biochips product portfolio. The in-vitro diagnostic device (IVD) offers analysis of 14 high-risk types of the human papillomavirus (HPV).
Virtually all cases of cervical cancer are caused by a persistent infection involving human papillomaviruses (HPV). Yet not every HPV type carries the same risk for the development of cervical cancer. The new PapilloCheck high-risk test focuses on parallel analysis of 14 HPV types of the high-risk group (hrHPV) that are recognised as carcinogenic.
In a recent clinical study, the test system based on microarray technology showed a clinically relevant sensitivity of 95.8% and a clinical specificity of 96.7% for the detection of high-grade precancerous lesions, thus meeting key requirements for fast and clear results in cervical cancer screening. PapilloCheck high-risk helps doctors assess patients’ risk of cancer more effectively. The costs for the PapilloCheck high-risk HPV test are covered by statutory health insurers if a smear test is inconclusive, i.e. with a Pap result of Class 3 or above. PapilloCheck high-risk is part of the oCheck product line from Greiner Bio-One GmbH.
Source: Greiner Bio-One