SAN DIEGO—This January, Illumina Inc. and KingMed Diagnostics 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.
“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 Dr. Garret Hampton, executive vice president of clinical genomics at Illumina.
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.
“Illumina [and KingMed] have had an established relationship for quite some time, as KingMed has been a long-time customer. Our established relationship, coupled with KingMed’s growing expertise in molecular, NGS-based esoteric testing and their broad hospital access, made it sensible for the two companies to work together,” Dr. Ruilin Zhao, Illumina's vice president and general manager of Greater China, tells DDNews.
Asked how long the companies believe it may take to create the new integrated NGS system, Zhao says, “Both entities are poised to move forward. We suspect that approval would be obtained within one-and-a-half to two years.”
“The key goal is for KingMed to get Chinese FDA approval of the MiniSeq, along with multiple NGS-based IVD assays for oncology testing. Twenty percent of the world’s cancer cases occur in China. As such, the Chinese government is seeking improved molecular methods for diagnosis and therapy selection. It is important that Illumina partners with a company that is familiar with the oncology space, and has an extensive reach into Class 3B and Class 2 hospitals, where a majority of Chinese patients are treated,” Zhao continues. “KingMed Diagnostics is one of the largest reference labs in China. They have a solid understanding of molecular testing using NGS, and a track record of working with NGS as a diagnostic tool.”
The integrated system will be able to reach cancer patients across China via KingMed Diagnostics’ extensive clinical network, which serves more than 8,000 Class 2 and Class 3B hospitals.
Chinese hospitals use a classification system, whereby Class 3 hospitals are the top hospitals serving regional and city needs, Class 2 hospitals serve cross-community needs and Class 1 hospitals serve small communities, or are currently yet to be classified. These hospitals are further categorized into A/B/C groups, where A is the best, dependent upon hospital hardware such as medical equipment, software and beds. Illumina and KingMed Diagnostics will be reaching a huge number of large, reputable hospitals in one fell swoop, if they do gain CFDA approval.
“KingMed Diagnostics’ motivation is to improve diagnosis and treatment for the more than four 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 Prof. Yaoming Liang, chairman and CEO 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.”
“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,” notes Zhao. “As we continue to expand our clinical partner networks, we are focused on providing the best healthcare solutions to patients throughout China.”