To introduce the history and regulatory policies of next-generation sequencing companion diagnosis and antitumor drug research and development in the United States in order to provide reference for practitioners in China.

Using literature research, case analysis, and comparative analysis, the challenges faced by China's next-generation sequencing companion diagnostics supervision and enterprise research and development were elaborated from the regulatory guidelines for next-generation sequencing companion diagnostics in the United States and the products approved by the US Food and Drug Administration.

Co-development of next-generation sequencing companion diagnosis and antitumor drugs can help explore and clarify the mechanism of drug action, accurately identify patients, and increase the success rate of antitumor drug development. With the advent of the era of precision medicine, the rapid development of next-generation sequencing technology and the policy of clinical value-oriented anti-tumor drug research and development, China's next-generation sequencing companion diagnosis and anti-tumor drug development are increasingly synchronous. It is necessary to propose corresponding regulatory policies and research and development guidelines to promote the development of next-generation sequencing companion diagnosis.