Zilico Non Invasive Cancer Diagnostic

Clinical Need

Cervical cancer diagnosis is a multi-step process based on an 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 for examination by a skilled histo-pathologist. Those patients demonstrating a positive smear test are then referred to a colposcopy 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 cervical intraepithelial neoplasia (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.

Solution

Zilico Limited utilises electrical impedance spectroscopy (EIS) as an objective scientifically-proven method to differentiate between normal, pre-cancerous and cancerous cells. EIS provides a real-time diagnosis that removes subjectivity and potentially avoids the need for a biopsy. The patented technology, which has been presented in peer reviewed journals, exploits the different electrical resistivity of normal, precancerous and cancerous cells. The initial application for the Zilico EIS device (Zedscan) is for patients referred to the colposcopy clinic because they have had a positive smear result and its use will enable the colposcopist to reduce the number of diagnostic biopsies and avoid the gross over-treatment of mild abnormalities. A second application of the technology 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) suggests that in the USA further evidence is required 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 and most HPV infections are self-resolving, and therefore a test that would confirm the disease state, like the Zedscan, would have significant utility.

The benefits of EIS:

  • 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 techniques
  • Reduces anxiety in patients (instantaneous results)
  • Reduces co-morbidity due to avoiding unnecessary biopsies
  • Ascertain exact location of lesion

Medipex’s Role

The idea for a new detection device originated from Professor Brian Brown, Head of Medical Physics at the University of Sheffield, and John Tidy, a Consultant Gynaecological Oncologist and Colposcopist at Sheffield Teaching Hospitals NHS Foundation Trust, when they began to explore the application of EIS to study biological tissues. Their work led to the development of a unique hand-held diagnostic device that provides efficient and instantaneous detection of pre-cancerous cells in the cervix. Following a successful clinical study, Medipex was approached to assess the opportunity and, if appropriate put in place a commercialisation plan.  It was agreed that Medipex would lead the commercialisation rather than the University of Sheffield as it had the most relevant expertise in the medical technology arena.  Medipex filed three patents with claims to a new cervical cancer diagnostic device, put in place an interim management team, developed the business plan, secured initial investment and established a new company, Zilico Ltd, to exploit the opportunity.  On completion of the founding investment round, a full time CEO and Technical Director were recruited to take over the day to day running of the business.  Medipex continued to support the business through its position on the board of directors of Zilico and through its wider stakeholder engagement with the investment and clinical community.

Impact

Zilico Ltd has developed the next generation of cancer diagnostics with an initial product line that provides real-time diagnostics for cervical cancer.

Although the technology was developed for the diagnosis of cervical cancer the underlying principle of using EIS to examine tissue structure will be applicable to other cancers e.g. oral anal, oesophageal and bowel cancers

Contact

For more information visit the Zilico website zilico.co.uk

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