Please could you give us a brief introduction to cervical cancer screening?
Cervical Cancer is a tragic disease. First and foremost, because it is entirely preventable if the early symptoms are detected in a timely manner; secondly because globally it is the second most common cancer in women with around 470,000 reported cases resulting in about 250,000 deaths every year.
Cervical Cancer screening has been adopted in most developed countries and has been successful in reducing the morbidity rate, but it still remains a challenging area.
How is cervical cancer screening currently performed?
Women are invited for a screening examination (commonly referred to as a Pap Smear test) every three years. The smear test gathers cellular samples from the surface of the cervix that are subsequently examined for abnormalities.
The vast majority of patients are pronounced normal at this stage, but a small number will have either High Grade or Low Grade abnormalities detected. In either case, the next step is for the patient to be referred for Colposcopy, which is direct visual examination of the cervix.
If pre-cancerous lesions are identified or suspected then it is usual that a biopsy sample will be taken and sent for analysis in a histology laboratory. The clinician will use the results of the histological analysis to determine the appropriate next steps.
What are the challenges with the current cervical screening process?
The key challenge is for clinicians to successfully identify any cervical lesion at the pre-cancerous stage, when treatment options are much more straightforward.
One of the key difficulties with colposcopy is the accuracy with which these lesions can be identified. The visual examination of the cervix is a highly subjective process where the clinician is appraising various visual indicators and using his or her experience to form an impression of the condition and where any biopsy should be taken.
Various clinical trials have established that colposcopy is indeed a very demanding task with approximately only 55% of cases requiring treatment being successfully identified. Most screening processes use repeat recalls on a six-monthly cycle to cope with this inaccuracy.
DySIS has recently developed a cervical cancer screening product. Please could you tell us more about this?
DySIS is a new type of colposcope that scans the cervix during the course of a normal examination. It presents the clinician with additional information in the form of a map (DySISmap) that substantially improves the ability to detect pre-cancerous lesions.
Our clinical trials have demonstrated that DySIS detects 97% of all pre-cancerous lesions that are created by the virus responsible for the majority of all cervical cancer cases.
How was this product developed?
Prof. Costas Balas of The Foundation for Research and Technology Hellas (FORTH) conducted fundamental research involving bio-photonic imaging of Cervical Neoplasia. He went on to invent the patented technique called Dynamic Spectral Imaging (from which the product name is derived) and to perfect the quantified assessment of the cervix.
What are the main benefits of the product?
The substantial gains in colposcopic sensitivity created by DySIS are preventing more women from progressing to more advanced forms of the disease where more invasive and more expensive treatments are required. This in turn is reducing the need to regularly recall patients who have an indeterminate colposcopic outcome.
Additionally the DySISmap results are digitally stored in the on-board patient database enabling patient referrals and longitudinal tracking. Last but not least, we are seeing that DySISmap creates an excellent tool for educating patients which in turn should reduce anxiety and stress.
The National Institute for Health and Clinical Excellence (NICE) has recently published positive diagnostics guidance regarding your product. What impact will this have?
NICE conducted a deep review of both the clinical and cost effectiveness of DySIS and I’m delighted that this resulted in the published positive guidance.
Given the position that NICE holds in the UK and in the international medical community I hope that this guidance is seen as a seal of approval – one that provides confidence in the ability for DySIS to deliver a high standard of care at an overall lower cost.
DySIS’s cervical screening product has been reported as “boosting sensitivity in detecting cervical cancer in its earliest stages”. How much of a problem has early detection of cervical cancer previously been?
In the UK, around 900 women die from cervical cancer every year. There are a variety of different reasons for this death rate but colposcopic sensitivity certainly plays its part. Litigation for missed diagnosis also seems to becoming more frequent both in the UK and other countries creating an even bigger economic impact.
Is there any danger of such a sensitive product producing false positives?
The job of colposcopy is to form an impression of the state of the cervix so that decisions can be made about the location of biopsy sites. The histological analysis of the biopsy samples is used for diagnosis. The impact of a false positive could therefore be for perhaps an unnecessary biopsy to be taken which does not create a significant impact on either patient or clinician and seems to be a reasonable trade-off for an accurate diagnosis.
Where can readers find more information?
About Alastair Atkinson, CEO of DySIS Medical Ltd
Alastair has over 25 years of Product Marketing, Development, Manufacturing and Sales experience within both corporate and start-up environments. He joined DySIS Medical from Optos plc where he served as the European General Manager, Global Product Director and was a member of the Senior Management team that floated the company on the main London market in 2006.
Prior to joining Optos Mr Atkinson had an 18 year career with Hewlett Packard holding a number of national and international positions. He has a BSc from Reading University, an MSc from Bristol University and completed the Advanced Management Program at INSEAD.