Ortho Clinical Diagnostics Recognized with Fifth Prestigious Edison Award for Highly Accurate COVID-19 Solution

Gold Award Recognizes Antibody Test

RARITAN, N.J., April 26, 2022 -- Ortho Clinical Diagnostics (NASDAQ: OCDX), one of the world's largest pure-play in vitro diagnostics (IVD) companies, has been recognized with a prestigious Gold 2022 Edison Award for its VITROS® Anti-SARS-CoV-2 IgG Quantitative Test COVID-19 testing solutions, helping labs meet demands of the pandemic with reliable mass-scale testing options.

The Edison Awards is an annual competition honoring excellence in new products and service development, marketing, design, and innovation. The awards committee recognized Ortho's impact on the health care community and the only standardized test calibrated to the World Health Organization Standard.

"Ortho remains on the front lines of helping the global health care community understand the long-term impacts of the COVID-19 virus. Receiving this prestigious recognition from Edison Awards for the fifth year highlights our continued success in delivering new innovative tools that enable clinical laboratory professionals around the world to meet the evolving needs of their patients and the communities they serve,” said Chockalingam Palaniappan, PhD, Chief Innovation Officer, Ortho Clinical Diagnostics. “We remain committed to delivering our COVID-19 antibody testing solutions to help our customers, and their patients better understand the immune response to COVID-19."

Ortho’s VITROS® Anti-SARS-CoV-2 IgG Quantitative Antibody Test product won in the Testing Solutions subcategory for COVID-19 Innovations after reviewing more than 350 nominations for new products and services development. This antibody test accurately measure the level of COVID-19 antibodies for patients and individuals in their communities and is the first quantitative test to receive U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA). The test received EUA approval in July 2021.

This is the fifth Edison Award for the company. Ortho is dedicated to delivering accurate test results, efficient and reliable instruments, easy-to-use technology and continuous collaboration to ensure customers are achieving the most important measure of success: exceptional patient care. Ortho was previously recognized with Edison Awards in 2021 for its VITROS® Anti-SARS-CoV-2 Total and IgG Antibody Tests and VITROS® SARS-CoV-2 Antigen Test, 2020 for its VITROS® XT Solutions, in 2018 for its VITROS® NEPHROCHECK® Test and in 2017 for the ORTHO VISION™ Platform.

"Ortho Clinical Diagnostics continues to innovate at a pace rarely seen in their industry. Their success is a reflection of the company culture and commitment to exceptional patient care by delivering accurate test results," stated Frank Bonafilia, Executive Director, Edison Awards.

The VITROS Anti-SARS-CoV-2 IgGnQuantitative test has not been FDA cleared or approved.  It has beennauthorized by the FDA under an Emergency Use Authorization and testing isnlimited to laboratories certified under the Clinical Laboratory ImprovementnAmendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or highncomplexity tests. This test has been authorized only for the detection ofnproteins from SARS-CoV-2, not for any other viruses or pathogens. Thesentests are only authorized for the duration of the declaration thatncircumstances exist justifying the authorization of emergency use of in vitrondiagnostic tests for detection and/or diagnosis of COVID-19 under Sectionn564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization isnterminated or revoked sooner. 

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