UK medical company launches reflux test in China
RD Biomed has announced that Peptest – a non-invasive device for diagnosing reflux disease – has been approved by Chinese health authorities and officially launched in China.
The device, which detects the presence of pepsin (recognised as a diagnostic biomarker for reflux) in saliva samples, will help advance the knowledge and management of reflux disease in China and change traditional diagnosis and treatment; leading medical experts have said.
Gastroesophageal reflux disease 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 Co.,Ltd – Peptest was introduced and validated in major clinical centres in Shanghai (seven hospitals) and Beijing (two hospitals) with more than 1,000 patients.
The study highlighted the advantage of using Peptest over traditional, invasive reflux diagnostic tests, with marked improvement in the accuracy of reflux diagnosis (with overall pepsin sensitivity of 85 per cent and specificity of 60 per cent).
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 launch ceremony for Peptest, at the Sheraton Grand Shanghai Pudong Hotel in Shanghai, featured guests, including Mr Mark Watson, a leading consultant Ear Nose and Throat (ENT) surgeon in the UK and the current President of the British Laryngological Association; Professor Peter Dettmar, founder of RD Biomed, inventor of Peptest and former developer of Gaviscon; Professor Fang Jingyuan, vice president and director of digestive department at Renji Hospital and Professor Doctor Serhat Bor, Chairman of the Turkish Gastroenterology Society.
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.”
FD Miao, CEO of Maxhealth Medicine Group Co, 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.”
The validation in China of a non-invasive salivary pepsin biomarker containing two unique human pepsin monoclonal antibodies to diagnose reflux disease report was published in the Journal of Digestive Diseases.
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