mtm laboratories introduces CINtec cytology kit in Europe

The CINtec cytology kit is an immuno-cytochemistry assay for the qualitative detection of the p16INK4a antigen on cervical cytology preparations. It is intended to be used as an aid in the identification of women with underlying high-grade cervical intraepithelial lesions in the sub-group of patients with a Pap cytology result of atypical squamous cells of undetermined significance or low grade intraepithelial lesion.

The clinical claims are derived from the outcome of a recent pan-European pivotal study involving pathologists and cytotechnologists from France, England, Spain, Italy and Germany. mtm’s CE-labeled CINtec cytology kit with extended claims will be marketed solely outside of the US.

Bob Silverman, CEO of mtm laboratories, said: “The results of this trial demonstrate that CINtec Cytology can more accurately identify those women with high grade disease than managing these cases with high risk-human papillomavirus testing. This is a major advance in cervical cancer screening, and for the women participating in screening programs.”