Chinese health authorities have approved RD Biomed’s non-invasive device for diagnosing reflux disease.
The device, which detects the presence of pepsin (recognised as a diagnostic biomarker for reflux) in saliva samples, aims to help advance the knowledge and management of reflux disease in China and change traditional diagnosis and treatment.
Gastroesophageal reflux disease (GERD) has been a common disease in Western countries for many years, but population studies have always indicated a lower prevalence in Asian countries.
However, a large-scale study across Shanghai and Beijing in China – published in the Journal of Digestive Diseases – has revealed that the prevalence for reflux disease in the Chinese population is much higher than previously reported.
Under the study – coordinated by Chinese medical company Maxhealth Medical Group– Peptest was introduced and validated in seven Shanghai hospitals, and two in Beijing, covering more than 1,000 patients.
The study highlighted the advantage of using Peptest over traditional, invasive reflux diagnostic tests, recording pepsin sensitivity of 85% and specificity of 60%.
FD Miao, CEO of Maxhealth Medicine Group, said: “Our study revealed the prevalence for GERD in the Chinese population was much higher than previously reported. Suggestions for this key result include a fast-growing westernised lifestyle in the country and previously GERD was often underdiagnosed. The introduction of Peptest will be useful in advancing the knowledge and management of the disease as it enables the rapid diagnosis of GERD in an easy-to-use, patient friendly test.”
MaxHealth, with its headquarters in Wuxi, has also led the registration of Peptest with the Chinese National Medical Products Administration (NMPA) and overseen its official launch into China this month.
An official ceremony launched the Peptest, at the Sheraton Grand Shanghai Pudong Hotel in Shanghai.
Professor Peter Dettmar, director at RD Biomed, said: “We’re thrilled that following years of intensive research and hard work from Chinese distributor MaxHealth, Peptest has been officially registered as a product with the Chinese National Medical Products Administration and is now available in the country.
“The medical device market in China is an important strategic target market so this is a momentous occasion for RD Biomed and Peptest. The recognition of pepsin as a biomarker for reflux disease, together with Peptest, enables the rapid diagnosis in clinical samples.”
