SOURCE: Ortho Clinical Diagnostics

Ortho Clinical Diagnostics

June 21, 2016 04:00 ET

Ortho Clinical Diagnostics Receives CE Mark Approval for VITROS® Immunodiagnostic HIV Combo Test

New Test Expands Infectious Disease Assay Portfolio; Will Become Commercially Available in Europe and Other Countries That Accept CE Mark in June

RARITAN, NJ--(Marketwired - Jun 21, 2016) - Ortho Clinical Diagnostics (Ortho), a global leader of in vitro diagnostics, announced that its VITROS® HIV Combo Test received CE Mark approval, signifying conformity with all 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 CE Mark in June 2016.

The VITROS® HIV Combo, a fourth-generation assay, detects both HIV-1 and HIV-2 antibodies and the p24 antigen, enabling 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 todayi. Starting antiretroviral treatment as soon as possible after diagnosis can help avert millions of AIDS-related deaths and new infectionsi. According to the U.S. Centers for Disease Control and Prevention, identifying patients in the early stages of infection is crucialii.

"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, test laboratories can 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 at two external testing laboratories in Europe and at Ortho's research and development laboratories confirmed it provides competitive sensitivity and specificity when compared with a leading commercially available fourth-generation testiii.

In the comparison studies, assay sensitivity was evaluated on seroconversion panels -- VITROS® HIV Comboi showed earlier detection of acute HIV infection in five of 34 seroconversion panels (agreement for 28 of 34 panels), indicating that the assay performance is very competitive in shortening the diagnostic window (the time between HIV infection and detection) -- a valuable attribute in HIV testing.

The assay's class-leading p24 sensitivity and uncompromised specificity is enhanced by the proprietary technologies and benefits only available on VITROS® Systems -- Intellicheck® Technology with its suite of quality checks (MicroSensor, SMART Metering) and VersaTip technology -- a combination that provides laboratories the accuracy needed to have the utmost trust in their results.

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
iii Data on File

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