Zilico Non Invasive Cancer Diagnostic
Zilico Ltd is a company spun out from Sheffield Teaching Hospital and the University of Sheffield and has developed the next generation of cancer diagnostics with an initial product line that provides real-time diagnostics for cervical cancer.
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A portable diagnostic device able to differentiate between healthy, pre-malignant and abnormal cells has been developed to provide superior performance over existing diagnostic procedures in the detection and treatment of cervical cancer. Based on electrical impedance spectroscopy, the device has undergone extensive testing and evaluation on nearly 1,000 patients in a number of clinical trials, all subject to peer reviewed publications and presented at key scientific meetings. Results from the latest multi-centre trial are forming part of the submission for regulatory approval with a view to the first product being launched in Q1 of 2013.
- Innovation Owner:
- Agnes Crutchard
- Development stage:
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Cervical cancer diagnosis worldwide is a multi-step process based on expert assessment of cervical smears (screening) and then the cervix itself (referral) and involves a significant measure of subjectivity. Initial screening (known as a smear test) involves taking a sample of cells from the cervix which is sent to a cytology laboratory where it is examined by a skilled histo-pathologist. Those patients demonstrating a positive smear are then referred to a clinic for a magnified visual examination of the cervix by a colposcopist who seeks to discriminate between normal, pre-cancerous, and cancerous cells.
The only way to positively confirm diagnosis of a pre-cancerous or cancerous lesion is by a biopsy. Ethical and economic issues mean that it is not practical for every woman to have a diagnostic biopsy as a routine screen. This current practice in screening (i.e. smears and referrals) involves a significant measure of subjectivity and has many shortcomings that mean it falls short of an effective diagnostic standard.
These shortcomings include:
• poor performance (false results), resulting in missed positives in smears and leading to over-treatment in colposcopy. The National Cervical Screening Programme in England sets the minimum acceptable level for colposcopy at >65%, which means that around 3 in every 10 women identified as
having high-grade CIN would in fact have no more than low-grade CIN which might resolve without treatment.
• a time delay in getting results to patients
• significant costs in running the screening programmes
Zilico has developed EIS into an objective scientifically-proven method to differentiate between normal, pre cancerous and cancerous cells. This provides a real-time diagnosis that removes subjectivity and potentially avoids the need for a biopsy. The patented technology, which has been presented in learned peer reviewed journals, exploits the different electrical resistivity of normal, precancerous and cancerous cells. The initial application for Zilico will be for patients referred to the colposcopy clinic because they have had a positive smear result and its use will enable colposcopists to better target biopsy sites thereby reducing the number of diagnostic biopsies and avoiding the gross over-treatment of mild abnormalities.
A second application of the technology, referred to as APX 200, will be launched later and is targeted at the very large cervical screening market (e.g. Smear test). The disruption to the clinical pathway by the introduction of vaccines has resulted in other products being developed. The recently introduced HPV molecular test will be the likely choice of front-line screening in the developed world as the test
is very sensitive though the bio-marker is not very specific. A recent update from The U.S. Preventive Services Task Force (USPSTF) suggest that in the USA they require further evidence before HPV tests will be used as a primary screen. However the test will require a triage (a test to identify those
HPV-positive women most likely to require referral) because it only confirms the presence of HPV rather than detecting actual disease so, with most HPV infections self-resolving, a test that would confirm disease state, like the APX 200, would have significant utility.
- Reduces the number of diagnostic biopsies by an estimated 30-50% and reduces the related morbidity (through a reduction in subjectivity of the colposcopy examination)
- Provides diagnosis in real time – earlier detection
- Performance is better - better predictive values when compared to current technique
- Reduces anxiety in patients (instantaneous results)
- Reduces co-morbidity due to avoiding unnecessary biopsies
- Ascertain exact location of lesion
Although the technology was developed for the cervical cancer application, the underlying principle of using EIS to examine tissue structure will be applicable to other cancers e.g. oral (research underway), anal, vulval and vaginal cancers.
- Clinical outcomes
- Acute Care