DySIS colposcope

DySIS acquires, displays and documents high-resolution still and sequentially captured images and videos and provides colour-coded mapping of the acetowhitening effect to facilitate and assist assessment and documentation. The DySIS intended operator is a medical professional allowed to perform colposcopic examinations. No particular technical expertise is required for operating DySIS.

DySIS integrates:

• Operation and image viewing on optimally placed touch-screen, improving ergonomics and clinical work-flow.
• Bright white-LED illumination for stable operation and long life-time.
• High resolution imaging sensor for crisp colour and spectral images.
• Three magnification scales.
• Surface reflections (glare) elimination by patented polarized optics.
• Colour-coded mapping of the tissue acetowhitening to assist evaluation, documentation and follow-up of cervical pathology.
• Data base for data storage, review and follow-up.

“DySIS has higher sensitivity than conventional colposcopy alone. There is no reliable evidence on the clinical effectiveness of [other technologies]. The results of the economic analysis suggest that DySIS is less costly and more effective than colposcopy alone and that these results are robust to the numerous sensitivity analyses that were undertaken.”

DySIS Impact

The DySIS clinical trials demonstrated that DySIS colposcopy has a sensitivity of 88% for the detection of High Grade (CIN2+) lesions while traditional colposcopy sensitivity is 55% (Louwers et al). Whilst this is a highly significant impact in its own rite, an earlier clinical trial demonstrated that, in a sub-cohort of patients referred to colposcopy with Low Grade Pap smear results, DySIS had a sensitivity of 77% detecting those that actually had High Grade (CIN2+) lesions whereas traditional colposcopy was shown to be only 19% sensitive (Soutter et al). The latter was judged by the Investigators to be a consequence of small lesion size that are hard to visualise with traditional colposcopy, but were detected and measured on DySISmap.

The immediate clinical impact of DySIS is to detect more patients that require treatment earlier in the clinical pathway. This gives rise to the following benefits:

A reduction in the number of patients that progress to Pre-Cancer or Invasive Cancer conditions that would have required higher cost treatments.

A reduction in the number of patients that are given 6 month Recall Appointments due to indeterminate colposcopy outcomes.

A reduction in the total number of biopsies that are taken from a given patient volume.

As a consequence of the above points, a substantial reduction in cervical screening costs.