Member Article

RD Biomed to launch reflux study in China

RD Biomed, the Hull-based medical technology company, will launch a study with over 1,000 patients in China to measure the effectiveness of its reflux diagnostic device Peptest.

The Peptest testing kit measures a patient’s saliva for levels of pepsin, an enzyme found only in the stomach. If a Peptest is positive for pepsin, then it indicates the patient is suffering from reflux.

The investigation study forms part of RD Biomed’s registration process with the Chinese FDA (CFDA) for the use of Peptest as a diagnostic device for reflux disease in the country.

It will involve the recruitment of 1,020 participants from 10 gastroenterology departments of hospitals in Shanghai and Beijing, a process led by Professor Jing-Yuan Fang, professor of medicine at Renji Hospital in Shanghai.

Peter Dettmar, director at RD Biomed, said: “This study will be by far the largest group of patients investigated using Peptest; the scale of the operations in China enables a much higher number of recruits than is possible in the UK.”

“Our trip to China has set the groundwork for the study which is required when registering your 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.”

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 indicates how effectively Peptest works, with a further meeting planned in March 2015 before recruitment will begin in all the centres. RD Biomed aims to launch Peptest in China in 2016.

This was posted in Bdaily's Members' News section by RD BIOMED .