The VITROS HIV Combo, a fourth-generation HIV assay, is designed to detect HIV-1 acute infection earlier than previous generations of HIV assays. According to estimates by the World Health Organization (WHO), 37 million people worldwide are living with HIV today. Starting antiretroviral treatment as soon as possible after diagnosis supports global initiatives to curb transmission of new infections and 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] More than 1.2 million people in the US are living with HIV, and yet 1 in 8 people (over 200,000) have status unknown, contributing to 54% of all new infections[iii]. The VITROS HIV Combo assay was CE-marked in 2016 and is currently available in Europe and other countries that accept the CE mark.
An estimated 240 million people worldwide are currently living with chronic hepatitis B, a life-threatening infection of the liver.[iv] Two of the assays used to diagnose hepatitis B, the VITROS® Immunodiagnostic Products HBeAg Assay and the VITROS® Immunodiagnostic Products Anti-HBe Assay, are currently approved for use on Ortho's VITROS® ECi/ECiQ Immunodiagnostic System. Ortho submitted two PMA supplements for review to migrate these existing assays onto Ortho's VITROS 5600 and VITROS 3600 systems, which would potentially expand their use.
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. 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. 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'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.
© Ortho Clinical Diagnostics 2017
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/ortho-clinical-diagnostics-submits-vitros-immunodiagnostic-products-hiv-combo-assay-to-fda-for-review-applies-to-expand-use-of-specialty-hepatitis-assays-300412689.html
SOURCE Ortho Clinical Diagnostics