Ortho Clinical Diagnostics Receives CE Mark Approval for VITROS(R) Immunodiagnostic HIV Combo Test*

RARITAN, NJ--(Marketwired - Jun 21, 2016) - Ortho Clinical Diagnostics (Ortho), a global leader of in vitro diagnostics, announced that its VITROS^® Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (VITROS^® HIV Combo Test) received CE Mark approval, signifying conformity with EU regulation. An important addition to the company's infectious disease portfolio, the new test will be available for purchase in Europe and other countries that accept the CE Mark in June 2016.

The VITROS^® HIV Combo, a fourth-generation assay, is designed to detect both HIV-1 and HIV-2 antibodies and the p24 antigen, to help enable HIV-1 acute infection detection earlier than third-generation assays.

According to estimates by the World Health Organization (WHO), 37 million people worldwide are living with HIV today.ⁱ Starting antiretroviral treatment as soon as possible after diagnosis can help avert millions of AIDS-related deaths and new infections.ⁱ According to the U.S. Centers for Disease Control and Prevention, identifying patients in the early stages of infection is crucial.ⁱⁱ

"Ortho is committed to expanding its assay menu and is investing in a pipeline that significantly improves laboratory outcomes for our customers," said Robert Yates, Ortho's chief operating officer. "With the launch of the VITROS^® HIV Combo in Europe and other CE Mark countries, test laboratories can help provide earlier detection of HIV for the benefit of their patients. Additionally, performing this test on VITROS® Systems provides the utmost confidence in results."

An assessment of the clinical and technical performance of the VITROS^® HIV Combo on VITROS^® Systems during routine use was completed at two external testing laboratories in Europe and at Ortho's research and development laboratories.

About Ortho Clinical Diagnostics

Ortho Clinical Diagnostics is a global leader of in vitro diagnostics serving the global clinical laboratory and immunohematology communities. Across hospitals, hospital networks, blood banks and labs in more than 120 countries, Ortho's high-quality products and services enable health care professionals to make better-informed treatment decisions. For the immunohematology community, Ortho's blood typing products help ensure every patient receives blood that is safe, the right type and the right unit. Ortho brings sophisticated testing technologies, automation, information management and interpretation tools to clinical laboratories around the world to help them run more efficiently and effectively and improve patient care. Ortho's purpose is to improve and save lives with diagnostics, and it does that by reimagining what's possible. This is what has defined Ortho for more than 75 years, and it's what drives Ortho forward. For more information, visit www.orthoclinicaldiagnostics.com.

VITROS^® is a trademark of Ortho Clinical Diagnostics.

© Ortho Clinical Diagnostics 2016

ⁱ http://www.who.int/hiv/en/
ⁱⁱ http://www.cdc.gov/std/treatment/2010/hiv.htm

*Not approved for the US Market.
Product availability subject to local regulatory requirements.