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Peptest, World's First Non-Invasive Reflux Diagnosis, Launches in China Following NMPA Approval

Sep 07, 2019

Peptest, a groundbreaking non-invasive diagnostic tool for reflux disease, has officially entered the Chinese market after receiving medical device registration from the National Medical Products Administration (NMPA). This launch coincides with the release of China's first multidisciplinary expert consensus on gastroesophageal reflux disease (GERD), which highlights the clinical promise of pepsin testing.

Coinciding with this launch, the first "Chinese Multidisciplinary Expert Consensus on Gastroesophageal Reflux Disease" was published. This landmark document, formulated by over 40 experts across more than 10 specialties, acknowledges pepsin testing in saliva as a "convenient, non-invasive method with good application prospects" for diagnosing laryngopharyngeal reflux, underscoring the clinical need Peptest addresses.

A Paradigm Shift in Reflux Diagnosis

Traditional methods for diagnosing reflux, such as endoscopy or 24-hour pH-impedance monitoring, are invasive, time-consuming, and costly, leading to patient discomfort and low testing rates. Peptest offers a revolutionary alternative.

"Peptest uses convenient, simple, and accurate operations to quickly help doctors achieve early diagnosis of reflux and related diseases," said Miao Fengdong, President of Maxhealth. "Its exclusive introduction by Maxhealth is of great significance for the rapid diagnosis of gastroesophageal reflux disease in China."

The test works on a simple principle: pepsin is an enzyme produced only in the stomach. Its presence in a saliva sample is a direct biomarker of gastric reflux into the esophagus, throat, or mouth. By measuring pepsin concentration, Peptest provides an objective, rapid result that aids in diagnosing GERD and its extra-esophageal manifestations, such as chronic cough or hoarseness.

Backed by Clinical Rigor and Global Partnership

Peptest's registration was supported by robust clinical validation involving over 1,000 cases in China, where it was successfully compared against existing diagnostic standards. The product is the result of a strategic partnership between Maxhealth and UK-based RD Biomed Ltd., the innovator behind the technology.

"Peptest is the world's first non-invasive in-vitro diagnostic reagent for esophageal reflux disease," stated Miao Fengdong. "We focus on global innovative medical technologies and promote the development, production, and commercialization of medical technologies in China and worldwide through transnational cooperation."

About Peptest:
Peptest is a rapid, non-invasive diagnostic test that detects the presence of pepsin in human saliva as a biomarker for gastroesophageal reflux disease (GERD) and laryngopharyngeal reflux (LPR). It offers a patient-friendly alternative to invasive procedures, delivering results quickly to aid clinicians in diagnosis and treatment planning.

About Maxhealth:
Maxhealth is an innovative medical technology platform specializing in R&D, production, and commercialization. Through global partnerships, the company identifies and introduces cutting-edge medical technologies to address unmet clinical needs in key therapeutic areas, including digestive diseases.