Zilico Ltd – Response to NICE Guidance 2018

Wednesday 25th April 2018

Adjunctive Colposcopy Technologies for Assessing Suspected Cervical Abnormalities

Zilico has offered a cautious welcome to NICE’s decision that further research is required with ZedScan™ before they can recommend it for routine adoption.

Read the NICE Guidance here

Despite the company submitting real-world data to NICE demonstrating the efficacy of ZedScan™ in identifying high-grade (HG) disease presence, this data was not considered in the review.

“We are pleased NICE has recognised the importance of the need for an adjunct diagnostic such as ZedScan™ and that it shows promise in assessing suspected cervical abnormalities, but disappointed that colposcopic impression (CI) (what a clinician thinks) only data was used to assess clinical efficacy.

Expert colposcopists will agree that, while it is true that colposcopic impression is important for assessing a colposcopist’s performance, for the woman being referred for a colposcopic examination the most important outcome is whether they have disease or not (DP).  This is the only outcome measure relevant to the woman undergoing colposcopic examination. The Cervical Screening Programme for England and other international programmes use the DP method to assess the performance of the programme.1

Zilico has always measured both colposcopic impression (CI) and disease present (DP) when evaluating the accuracy of ZedScan™.  For NICE to make a recommendation based on one data set that is not reflective of standard clinical practice is questionable and not focused on patient outcomes.” 

ZedScan™ is a unique adjunct diagnostic, which uses electrical impedance spectroscopy (EIS) technology to differentiate between normal, low-grade, and (pre-cancerous) high-grade abnormalities.  Real-world data demonstrates ZedScan™ detects more women with high-grade abnormalities than colposcopy alone. This helps clinicians better manage patients, providing a more cost-effective pathway for cervical disease, as ZedScan™ also reassures clinicians when there is no disease present, reducing the need for follow-up appointments and multiple biopsies.2,3,4

2019 will see the introduction of a new primary HPV screening programme throughout England which will replace the existing cytology screening programme, making these recommendations redundant by the end of the year, as they are based on the old programme.  A large series of patients (839) examined as part of the primary HPV testing pilot programme confirmed the clinical benefits of using ZedScan™ including improved detection of disease irrespective of HPV genotype.5

“We are optimistic about the uptake of ZedScan™ in the UK. Week-on-week, we are starting to see an increase in the number of centres starting to evaluate the device. Those centres that have completed their evaluations and have routinely adopted ZedScan™ into clinical practice are in the process of publishing their real-world data, which is what clinicians are interested in.”

Centres that have adopted or are evaluating ZedScan™ recognise the need for the technology to help better manage patients, as they prepare for the impact primary HPV testing will have on their clinics. 

“We will however, continue to increase our global data set and take on-board NICE’s comments.  We have recently appointed Dr Michael Gold, past president of the American Society of Colposcopy and Cervical Pathology (ASCCP) to our medical advisory board, to work with us on the data required for FDA approval.  We are also running a similar programme in China where we are applying for CFDA approval.”

The CI (Colposcopic Impression) method reports the outcome of Colposcopy as negative if the clinical opinion is that HGCIN is not present, even though in many cases a biopsy is still taken to exclude disease.

The DP (Disease present) method reports the outcome of Colposcopy on the results of all biopsies taken irrespective of whether the colposcopists thought there was disease present or not.

References

  1. NHS Cervical Screening Programme Colposcopy and Programme Management NHSCSP Publication number 20 Third Edition March 2016 https://www.bsccp.org.uk/assets/file/uploads/resources/NHS_Cervical_Screeing_Programme._Publication_Number_20_-_Third_Edition.pdf  
  2. Tidy, J.A, Brown BH, Healey TJ, Daayana S, Martin M, Prendiville W, Kitchener HC. “Accuracy of detection of high-grade cervical intraepithelial neoplasia using Electrical Impedance Spectroscopy with colposcopy.” Br J Obstet Gynaecol 2013; 120: 400–411.
  3. Tidy, J.A., Brown, B.H., Lyon, R.E., Healey, T.J., Palmer, J.E. (2017) “Are colposcopy and electrical impedance spectroscopy complementary when used to detect high-grade cervical neoplasia?” European Journal of Gynaecological Oncology
  4. Tidy, J.A, (2017) Primary HPV Screening and the Impact of ZedScan on Patient Management.  Data presented at the Asia-Oceania Research Organisation in Genital Infection and Neoplasia. (AOGIN)
  5. Macdonald, M.C., Brown, B.H., Lyon, R.E., Healey, T.J., Palmer, J.E. Tidy, J.A. (2017) “Influence of high risk HPV genotype on colposcopic performance: A large prospective study demonstrates improved detection of disease with ZedScan I, particularly on non-HPV16 patients” European Journal of Obstetrics and Gynaecology and Reproductive Biology http:/dx.doi.org/10.1016/j.ejogrb.2017.02.020
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