Zilico’s Cervical Cancer Diagnostic Device Lands CE Mark
Zilico Ltd has received EC certification from its Notified Body for its cervical cancer diagnostics device, ZedScan I.
The UK company’s ground-breaking system offers quicker and more accurate detection of cervical neoplasia in real-time, enabling clinicians to improve patient management.
The ZedScan I system is used alongside colposcopy on women identified with an abnormal smear result. ZedScan offers clinical benefits by identifying the optimum biopsy site and so reducing the number of cervical biopsies required whilst also facilitating a wider use of 'select & treat'.
As well as its clinical benefits, a recent independent health economics report demonstrated that ZedScan delivers cost-effective benefits to healthcare systems.
Zilico’s patented Electrical Impedance Spectroscopy (EIS) technology exploits the different electrical resistivity of normal, pre-cancerous and cancerous tissue.
The system, which is both safe and painless, consists of a portable hand-held device and docking station, software application and a single-use EIS sensor. Five clinical trials in the UK and EU have supported the clinical efficacy of ZedScan, including a pivotal European trial of 429 women in 2011 across three hospitals in the UK and Ireland.
The company has been presenting these results at key scientific meetings and high-profile healthcare conferences across the world, including ASCCP 2012 at which it received the ‘Best Scientific Presentation’ award.
Following EC certification, ZedScan is being introduced into a number of clinics in the UK and healthcare systems across the globe.
Sameer Kothari, Chief Executive of Zilico Ltd, said: “ZedScan has the potential to make a significant impact on how women are managed within the cervical cancer pathway by providing better information to the clinician in real-time and its European approval is an important advancement for clinicians, healthcare systems and patients.
ZedScan has generated substantial interest from clinicians across the globe through various presentations, conferences and clinical meetings and we now look forward to being able to satisfy the growing demand as colposcopy clinics seek to implement this breakthrough system and exploit the clinical and health economic benefits it will bring through better patient management.”
Zilico Ltd was spun out of the University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust. Professor John Tidy, a Consultant Gynaecological Oncologist at the Royal Hallamshire Hospital Sheffield, co-founded the Company with Professor Brian Brown, from the University of Sheffield’s Department of Cardiovascular Science, with his early development work on Electrical Impedance Spectroscopy (EIS).
Photo caption: The ZedScan I in its docking station
Notes to Editors
Zilico Ltd is a company developing the next generation of cancer diagnostics with a product line which will provide real-time diagnostics. Zilico has developed Electrical Impedance Spectroscopy, EIS, an objective scientifically-proven method to differentiate between normal and pre cancerous and cancerous cells (neoplasias), into a technology that can address the need for improved detection and diagnosis of neoplasia.
The lead product is within the cervical cancer diagnostic pathway. Within this pathway two product applications are under development: the first for the referral market (patients) and the second for the screening market (women).
ZedScan I, the first product within cervical cancer diagnostics, is positioned within the referral population, will reduce the number of biopsies taken and has the potential to facilitate the wider use of ‘select & treat’ modality. Clinical data on over 1000 women has demonstrated superior performance over existing diagnostic procedures.
Zilico’s patented technology, which has been discussed in learned peer-reviewed journals, exploits the different electrical resistivity of normal, pre-cancerous and cancerous cells. The Company has recently embarked on a proof-of-concept 50 patient trial for diagnosing oral lesions.
The early development work was carried out at the Sheffield Teaching Hospitals NHS Foundation Trust and the University of Sheffield.
Since incorporation in 2006, Zilico has focused on developing a research-based instrument into a device appropriate for commercial manufacture and routine use by medical practitioners. Both Zilico product applications consist of a handheld device and a base unit together with a Single-Use EIS Sensor for each test.
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Posted: October 2013