Cervical Cancer Screening Technology Provides Cost-Effective and Effective Diagnosis

The device uses a range of colors to indicate normal and abnormal cells, and the degree of abnormality present.

DySIS Medical, Ltd. (Edinburgh, Scotland, UK), a medical devices company focused on female health, announced that the National Institute for Health and Clinical Excellence (NICE; London, UK) has published positive diagnostics guidance recommending its DySIS cervical cancer screening product to be considered in procurement plans. The guidance document can be viewed in full online (please see Related Links below).

In clinical trials, DySIS has been shown to significantly boost sensitivity in detecting cervical cancer in its earliest stages.

Equipped with these additional data, clinicians are able to take immediate steps to treat patients and prevent disease progression. This then creates a substantial economic impact by reducing the volume of higher cost surgical interventions.

The NICE guidance stated, “DySIS is a clinically and cost-effective option, compared with standard colposcopy, for examining the uterine cervix in women referred for colposcopy, and should be considered in procurement plans for colposcopy equipment.”

Charles Redman, consultant gynecologic oncologist at North Staffs Hospital and an early user of DySIS, commented, “DySIS is a very exciting technology that delivers an excellent solution in a critical area of women’s health. We have made excellent progress in reducing the incidence of cervical cancer in the UK through a good screening program, but detecting the disease early is still a significant challenge. Today we have to use visual assessment, a lot of judgment, combined with several recall visits for some patients, to try to catch the disease. The DySIS instrument uses hi-tech imaging and provides objective measurements that we can use to substantially improve our sensitivity to detecting the disease before it’s too late.”

Extensive clinical trials on DySIS have been undertaken across Europe involving hospitals in the UK, Netherlands, and Greece. The most recently published results showed that DySIS helped clinicians to identify pre-cancer conditions caused by the virus responsible for the vast majority of cervical cancers in 97% of all cases.

New users can be trained to interpret the DySISmap, in two to four hours. The goal of the technology is to provide reassurance that the highest level of analysis has been undertaken and abnormal cells or potential cancers have not been missed. DySIS has a CE mark and has been cleared for use by the US Food and Drugs Administration. The company estimates that around 4,000 women to date have had a DySIS exam through the installed base of instruments across Europe.

Alastair Atkinson, CEO of DySIS Medical, said, “Achieving NICE [approval] is a landmark event for our Company. This positive guidance recognizes the paradigm shift that DySIS can create--helping clinicians to deliver a higher standard of care at a lower overall cost.”

DySIS Medical is focused on the early detection and diagnosis of disease using biophotonic developments. It is also involved in automated optical molecular imaging technologies for medical diagnostic and screening applications. The DySIS cervical cancer screening product system uses sophisticated photonics and computer assistance to quantify and map the acetowhitening process--providing clinicians with reliable information to assist in the identification of precancerous lesions. The device is sold in Europe and the United States.

Related Links:
DySIS Medical
DySIS Medical Guidance
UK National Institute for Health and Clinical Excellence