The Peptest team has just returned from a trip to China where we met with key opinion leaders as part of the process of registering Peptest for use as a diagnostic device for reflux disease in the country.
We discussed our upcoming investigation study, which will involve the recruitment of 1,020 participants from 10 gastroenterology departments of hospitals in Shanghai and Beijing, with our Chinese partner MAAB International presenting the draft protocol for the study.
In a process led by Professor Jing-Yuan Fang, professor of medicine at Renji Hospital in Shanghai, participants will be put into three groups according to their symptoms and endoscopic results:
1. Erosive reflux disease – GERD symptoms plus damage shown by endoscopy
2. Non-erosive reflux disease (NERD) – confirmed reflux diagnosis by questionnaire but normal by endoscopy.
3. Controls – no reflux symptoms and negative by questionnaire (GERDQ).
The study will assess the sensitivity and specificity in each of these groups and demonstrate how effective Peptest is for diagnosing reflux.
It will be by far the largest group of patients investigated using Peptest, with the scale of the operations in China enabling a much higher number of recruits than is possible in the UK.
It is part of the process of registering a product with the Chinese FDA (CFDA). It is a similar process we had to follow in UK for European CE mark and registration and we are currently also doing in Taiwan, Brazil and Singapore, and plan to do in the US.