DySIS^TM - The Clinical Evidence

DySIS^TM has been tested in a large, multi-site clinical study enrolling 447 women. The study, designed as a multi-center, non-randomized paired clinical trial, was set up in accordance to the Declaration of Helsinki and the guidelines of ISO 14155-1 (2003).

The purpose of the study was to compare the performances of DySIS^TM, conventional colposcopy and cytology in discriminating high-grade from non high-grade cervical neoplasia.

The receiver operator characteristic (ROC) curve of DySIS had an area under the curve of 0.844, demonstrating an outstanding performance.

The improvement in overall performance is illustrated by the Diagnostic Odds Ratio (DOR) presented comparatively below:

In this study the DOR of DySIS^TM was
71% higher than that of cytology and
49% higher than that of colposcopy

DySIS^TM detected 22 high-grade cases
missed by conventional colposcopy

DySIS^TM technology obtains results by following
an objective and quantifiable process rather than
the subjective impression of an experienced colposcopist