Clinical Investigation Results – DYSIS Medical

Clinical Investigation Results

Clinical Investigation Results

DYSIS Clinical Investigation Results.

DYSISmedical, the company behind the world’s first digital mapping colposcope, has announced that their DYSIS product has been the subject of a clinical investigation, with results that demonstrate its capacity to detect pre-cancerous lesions of the cervix.

A newly published article, available online by BJOG: An International Journal of Obstetrics & Gynaecology, investigates the agreement between conventional colposcopic impression, dynamic spectral imaging colposcopy provided by DYSIS and histology, in identifying patients with high-grade cervical lesions among human papillomavirus type 16-positive (HPV16+) and non-16 high-risk (hr) HPV positive women.

Undertaken in three colposcopy clinics in the Netherlands in women aged 18 years or over, with an intact cervix and referred for colposcopy, the colposcopist first examined the cervix using DYSIS as a regular video colposcope. Subsequently, the DYSIS map was displayed and biopsies were taken from all areas suspected for abnormality, as well as from a random (apparently normal) site; a cervical smear was taken for HPV typing.

The analysis demonstrates that DySIS identified CIN2+ cervical lesions among HPV16+ women with a sensitivity of 97% and a specificity of 100%. The authors also conclude that the sensitivity of traditional colposcopy is overall low, probably because colposcopists tend to miss smaller cervical lesions.

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Notes for editors:

The full text of the Zaal A et al (2012) article entitled ‘Agreement between colposcopic impression and histological diagnosis among human papillomavirus type 16-positive women: a clinical trial using dynamic spectral imaging colposcopy’ can be accessed at

Cervical cancer is the second most common cancer in women and the World Health Organization estimates that there are over 500,000 new cases each year resulting in 250,000 deaths. In the developed world, where screening programmes are used, some 30 million women will receive an abnormal smear test result and be called for a colposcopy examination.

The DYSIS employs advanced photonics and computer assistance to quantify and map the aceto-whitening process – providing clinicians with reliable information to assist in the identification of pre-cancerous lesions.

DYSISmedical Ltd has its global headquarters in Edinburgh. The company is committed to saving lives through the early detection and diagnosis of disease using biophotonic innovations. It aims to be the global leader in automated optical molecular imaging technologies for medical diagnostic and screening applications.