Pepfast Achieves NMPA, CE, and FDA Clearances

Pepfast, our second‑generation, non‑invasive reflux diagnostic test, received NMPA registration in China in May 2025. Just seven months later, in December 2025, the product secured both CE marking and FDA clearance—enabling access to markets across Europe and the United States.

Pepfast is a rapid saliva test that detects pepsin, a direct biomarker of reflux, without the need for centrifugation. Results are available in 15 minutes, offering a streamlined solution for fast, objective reflux assessment in clinical and community settings.

These regulatory milestones mark a significant step forward in making accurate, patient‑friendly reflux testing accessible worldwide. With approvals now secured in three major regions, Pepfast is ready to support healthcare providers globally in delivering timely, non‑invasive diagnostic insight.