Long-term partnership targets rapid assay development for local market needs

QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho” or the “Company”), a global provider of innovative in vitro diagnostics (IVD) technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today the signing of a definitive agreement to form a joint venture (JV) between Ortho Clinical Diagnostics Trading (China) Co., Ltd., a subsidiary of QuidelOrtho, and Shanghai Medconn Biotechnology Co., Ltd., a subsidiary of Shanghai Runda Medical Technology Co., Ltd. (“Runda Medical”) to develop and manufacture assays in China for QuidelOrtho’s VITROS® platform.

“Our partnership with Runda Medical will help expand our already-compelling menu of VITROS assays abroad as well as in the Chinese market, an important, fast-growing region for us,” said Douglas Bryant, President and Chief Executive Officer of QuidelOrtho. “We’re happy with our long-standing partnership and believe that this joint venture will translate into a faster time to market and more compelling menu for VITROS assays in support of our growth strategy in China and beyond.”

QuidelOrtho develops IVD reagent products that meet the needs of the Chinese market with a significant installed base of VITROS immunodiagnostic analyzers, including but not limited to VITROS 3600 and 5600 instruments and the VITROS Automation System that connects these instruments, and has a leading position in quick turnaround STAT labs across China. Runda Medical is a leading IVD distributor in China and has developed its own family of instruments and assays. The JV will leverage both parties’ know-how in a range of incremental assays to broaden the VITROS test menu and gain efficiencies from local manufacturing at Runda Medical’s Shanghai facility. Both companies will contribute personnel and expertise to the joint venture and will share in the profits of the jointly developed products.

“Our longstanding collaboration with Runda Medical has enabled us to become a leader in commercial execution in the China market over the past 20 years,” said Iris Lin, Head of Greater China of QuidelOrtho, who will continue in this role and also assume the role of General Manager of the JV. “We value our partnership with Runda Medical and with their expanded immunoassay menu, we look forward to rapidly launching important assays to the market with accurate, efficient results.”

“Runda Medical has maintained a close and positive working relationship with Ortho for nearly two decades. This partnership is another in-depth strategic cooperation in the field of in vitro diagnostic product research, development and production. Both parties make full use of complementary resources and commit to providing medical laboratories with higher quality in vitro diagnostic platforms and reagents and providing effective support for the diagnosis and treatment of clinical diseases," said Hui Liu, General Manager of Runda Medical.

Following a successful assay pilot program, both companies expect to begin developing a broader set of assays in early 2023 in parallel with building out the JV organization in the Shanghai and Beijing areas.

About QuidelOrtho Corporation

QuidelOrtho Corporation (Nasdaq: QDEL) unites the power of Quidel Corporation and Ortho Clinical Diagnostics behind a shared mission of developing and manufacturing innovative technologies that raise the performance of diagnostic testing and create better patient outcomes across the entire healthcare continuum.

Ranked among the world’s largest in vitro diagnostics (IVD) providers with more than 120 years of collective experience, we combine industry-leading expertise in immunoassay and molecular testing with a global footprint in clinical labs and transfusion medicine.

Our company’s comprehensive product portfolio delivers accuracy, speed, automation and access, providing critical information when and where it is needed most. Inspired by a spirit of service, QuidelOrtho is committed to enhancing the well-being of people worldwide and happy in the knowledge we are making a difference. For more information, please visit www.quidelortho.com.

Source: QuidelOrtho Corporation

About Runda Medical Technology

Runda Medical is one of the leading enterprises for product distribution and comprehensive services in the in vitro diagnostic (IVD) industry in China. Having been deeply engaged in the IVD industry for more than 20 years, Runda Medical has rich experience in supply chain and technical services for IVD products and is committed to providing all types of medical laboratories with integrated medical laboratory services, including various medical solutions, a full range of IVD products and professional technical support. Runda Medical has built a comprehensive business ecosystem consisting of integrated laboratory service platforms, IVD product research, development and production, medical informatization, third-party laboratory testing services and other services. Currently, Runda Medical has more than 50 holding subsidiaries, providing integrated laboratory services to more than 4,000 public medical institutions in China.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements and other forward-looking statements in this press release by words such as “may”, “will”, “would”, “expect”, “anticipate”, “believe”, “estimate”, “plan”, “intend”, “continue” or similar words, expressions or the negative of such terms or other comparable terminology. These statements include, but are not limited to, QuidelOrtho’s future plans, objectives, strategies, expectations and intentions, and other statements that are not historical facts. Such statements are based on the beliefs and expectations of QuidelOrtho’s management as of today and are subject to significant risks and uncertainties. Actual results may differ significantly from those set forth or implied in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth or implied in the forward-looking statements: the challenges and costs of integrating, restructuring and achieving anticipated synergies; the ability to retain key employees; and other economic, business, competitive, and/or regulatory factors affecting the business of QuidelOrtho generally. Additional risks and factors are identified under “Risk Factors” in QuidelOrtho’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “Commission”) on August 5, 2022, and subsequent reports filed with the Commission.

You should not rely on forward-looking statements as predictions of future events because these statements are based on assumptions that may not come true and are speculative by their nature. QuidelOrtho has no obligation to update any of the forward-looking information or time-sensitive information included in this press release, whether as a result of new information, future events, changed expectations or otherwise, except as required by law. All forward-looking statements are based on information currently available to QuidelOrtho and speak only as of the date hereof.

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