GUANGZHOU, China, October 10, 2026 — Burning Rock Biotech Limited (“Burning Rock”) announced that its OncoCompass® Target CDx Kit has entered the National Medical Products Administration (NMPA) Priority Approval Procedure for Medical Devices.

OncoCompass® Target CDx Kit is an NGS-based liquid biopsy kit for comprehensive genomic profiling using plasma ctDNA. While tumor tissue remains the gold standard for molecular testing, its use can be limited by sample accessibility and quality, and single-site biopsies may not fully capture tumor spatial heterogeneity. Plasma ctDNA testing provides a complementary approach, enabling comprehensive molecular profiling with minimally invasive sampling and shorter turnaround times to support timely treatment decisions.

This milestone builds on Burning Rock’s extensive experience in companion diagnostic development. The Company has collaborated with more than 150 pharmaceutical companies worldwide, with more than 20 CDx programs currently in development. Its products have been approved in major markets including China, the United States, Japan and Europe.

Burning Rock continues to expand its NGS-based precision oncology portfolio across clinical applications. In 2026, OncoScreen® BCMatch Tissue Kit entered the same NMPA Priority Approval Procedure, while two WES-based tumor-informed personalized MRD kits entered the NMPA’s Special Review Procedure for Innovative Medical Devices.

Driven by clinical needs and committed to compliant innovation, Burning Rock will continue to advance the clinical validation and regulatory development of innovative diagnostic technologies, bringing more precision oncology solutions to clinical practice.