Illumina and KingMed Diagnostics have announced an agreement to jointly develop novel oncology and hereditary disease testing applications utilizing Illumina's next-generation sequencing (NGS) technology. The collaboration is a significant step toward China Food and Drug Administration (CFDA) review and approval, and serves as a starting point to deliver precision medicine to patients throughout China.

Under the agreement, Illumina and KingMed Diagnostics will partner to co-develop an integrated NGS system that provides cost-effective and ready-to-use in-vitro diagnostic (IVD) assays for molecular oncology and hereditary cancer testing. The new system is based on Illumina's MiniSeq System and related sequencing consumables, integrated with KingMed Diagnostics' proprietary testing components, which include library preparation kits and analysis software.

The integrated system can reach cancer patients across China via KingMed Diagnostics' extensive clinical network that serves more than 8,000 Class 2 and Class 3B hospitals.

"KingMed Diagnostics' motivation is to improve diagnosis and treatment for the more than 4 million new cancer patients identified in China each year. Our mission is to bring state-of-the-art technology to Chinese patients by enhancing their standard of care and improving their outcomes," said Professor Yaoming Liang, chairman and chief executive officer of KingMed Diagnostics. "Illumina is the ideal collaborator because they have a proven track record of working with multiple domestic companies in China, in addition to being the first company with a U.S. FDA-cleared, next-generation sequencing instrument."

"KingMed Diagnostics is one of the leading independent clinical laboratory service providers in China, and as such, we are excited to partner with them to help customize the MiniSeq System under CFDA requirements for clinical oncology applications," said Garret Hampton, Ph.D., executive vice president of Clinical Genomics at Illumina.

"This agreement is a clear demonstration of our commitment to working with broader clinical testing service providers in China who want to develop and commercialize IVDs based on NGS," said Ruilin Zhao, Ph.D., Illumina's vice president and general manager of Greater China. "As we continue to expand our clinical partner networks, we are focused on providing the best healthcare solutions to patients throughout China."