On July 23, 2018, National Medical Products Administration (NMPA) vetted and granted a license to Burning Rock Biotech(Guang Zhou) Co., Ltd. (hereinafter referred to as Burning Rock Dx) for making a creative high-throughput product - ”human-targeted EGFR/ALK/BRAF/KRAS polygene mutation testing kit (reversible terminator sequencing) (hereinafter referred to as "the kit")”. The kit is a Class III medical equipment product.

The kit is China’s first polygene tumor mutation testing kit based on high-throughput NGS and companion diagnostics standards approved, which will be an aid to non-small cell lung cancer patients for selecting precision targeted drug therapies. In September 2016, NMPA approved the kit to enter “special approval procedures for creative medical equipment” as China's first NGS cancer testing product. And two years or so later, the NMPA ultimately granted the “first NGS cancer testing product license” of profound significance after rigorous verification of mass clinical samples in clinical trials and vetting in the licensed product quality system.

Compared with traditional genetic testing methods, NGS informs patients of many cancer-therapy-related hotspots and non-hotspots in mutation panorama and covers point mutation, insertion loss and rearrangement (fusion) among other forms of variation to render a one-stop testing solution involving many targeted drugs to doctors and patients with fewer testing samples and shorter testing duration.

NGS has been accepted by clinicians in precision medicine and companion diagnostics. But as a sophisticated technology, NGS runs into quality system standardization and normalization bottlenecks in clinical routine. The license granted to Burning Rock Dx's kit marks that NGS cancer testing will be duly put into use in hospitals’ clinical labs. Beyond doubt, it is a landmark in the march of making NGS benefit more cancer patients.

Meanwhile, Burning Rock Dx-CTONG Laboratory in Guangzhou was awarded a technical vetting qualification certificate for “high-throughput sequencing lab” by National Center for Clinical Laboratories, National Health Commission in this May. Burning Rock Dx’s NGS testing platform as a laboratory developed test (LDT) project provides clinical sample testing service for a variety of cancer patients that fall into more stages. At the moment, it is the only institution in China that has passed China’s technical vetting on anti-cancer high-throughput sequencing labs and U.S. CLIA NGS lab certification for LDTs through a demanding review on its testing capacity in line with relevant national and international quality control regulations and systems.

Mr. Han Yusheng, Founder and CEO of Burning Rock Dx, said, “Burning Rock Dx will keep devoting to developing professional, accurate and sensitive NGS cancer testing techniques. We’d appreciate relevant national regulators and specialists for unremitting effort in speeding up introducing outstanding creative techniques to clinical practice. In the future, we are confident and competent that we will make China’s NGS industry more accurate and standardized and hike up industrial standards and benefit more cancer patients through tight cooperation with specialists in the industry. In addition, Burning Rock Dx is working on key techniques and developing early cancer screening products to further advance when cancers are diagnosed and contribute to higher rate of survival in cancer therapy.”