GUANGZHOU, China, August 25, 2026 — Burning Rock Biotech Limited (“Burning Rock”) announced that its personalized minimal residual disease (MRD) test CanCatch Custom Kit has entered the Special Review Procedure for Innovative Medical Devices of China’s National Medical Products Administration (NMPA). This is the first tumor-informed personalized MRD kit using whole-exome sequencing (WES) for baseline profiling to enter the procedure in China.

The product creates a patient-specific molecular fingerprint to sensitively track residual tumor signals after surgery. Results from the MEDAL study, published in Cancer Cell, demonstrated a limit of detection (LOD) as low as 0.0036% and a negative predictive value (NPV) of 96.6% for longitudinal recurrence monitoring. MRD detection preceded radiographic recurrence by an average of 299 days, while providing complementary molecular evidence to support recurrence risk assessment and follow-up management.

As a pioneer in WES-based personalized MRD, Burning Rock is making important regulatory progress with its CanCatch Custom Kit, marking a crucial step toward moving personalized MRD testing beyond the constraints of centralized laboratory services. The product's kit-based format is designed to enable standardized testing, broader clinical adoption, and the compliant implementation of WES-based personalized MRD testing across global healthcare settings.

Since its founding, Burning Rock has remained committed to advancing precision oncology through clinically meaningful innovation and close engagement with regulatory authorities to facilitate the compliant translation of novel technologies. Three of the Company’s breakthrough products have entered China’s Special Review Procedure for Innovative Medical Devices.

✅ In 2016, Burning Rock’s OncoScreen® Focus Tissue Kit, the first tumor NGS companion diagnostic assay in China, entered the Special Review Procedure for Innovative Medical Devices and subsequently received China’s first NMPA registration certificate for a tumor NGS test in 2018.

✅ In 2023, Burning Rock’s OverC™ Multi-Cancer Detection Blood Test, the first multi-cancer early detection (MCED) product in China, entered the NMPA Special Review Procedure for Innovative Medical Devices and remains the only MCED product globally to have entered innovation procedure in both China and the United States.

✅ In 2026, Burning Rock’s personalized MRD product CanCatch Custom Kit, the first WES-based tumor-informed personalized MRD kit in China, has entered the NMPA Special Review Procedure for Innovative Medical Devices.

Building on these milestones, Burning Rock will continue to advance precision oncology innovation and collaborate with regulators to accelerate the responsible clinical translation of innovative diagnostic technologies, with the goal of improving outcomes for patients with cancer.