Illumina and KingMed Diagnostics Partner to Develop Next-Generation Sequencing Technology for Chinese FDA Approval

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SAN DIEGO–(BUSINESS WIRE)–Illumina, Inc. (NASDAQ: ILMN) and KingMed Diagnostics (SSE: 603882.SS) today 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 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.”

“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.”

About KingMed Diagnostics

Guangzhou KingMed Diagnostics Group Co., Ltd. (www.kingmed.com.cn) was established in 2003 as the leading independent clinical testing laboratory in China that has been serving over 21,000 medical institutions as our customers. KingMed develops and commercializes an extensive medical, pathological and genomic testing offering with over 2,400 testing items to a wide range of medical and healthcare institutions with its 37 established testing laboratories across China. KingMed made a successful IPO at Shanghai Stock Exchange in 2017.

About Illumina

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit www.illumina.com and follow @illumina.

Use of forward-looking statements

This release contains forward-looking statements that involve risks and uncertainties. These forward-looking statements are based on our expectations as of the date of this release and may differ materially from actual future events or results. Among the important factors that could cause actual results to differ materially from those in any forward-looking statements are (i) our ability to further develop and commercialize our instruments and consumables, and to deploy new products such as the MiniSeq instrument, services and applications, and expand the markets for our technology platforms; (ii) our ability to manufacture robust instrumentation and consumables; (iii) our ability to successfully identify and integrate acquired technologies, products or businesses; (iv) the future conduct and growth of the business and the markets in which we operate; and (v) challenges inherent in developing, manufacturing, and launching new products and services, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts’ expectations, or to provide interim reports or updates on the progress of the current quarter.