Ortho Clinical Diagnostics Submits VITROS® Immunodiagnostic Products HIV Combo Assay to FDA for Review; Applies to Expand Use of Specialty Hepatitis Assays

RARITAN, N.J., Feb. 23, 2017 /PRNewswire/ -- Ortho Clinical Diagnostics (Ortho), a global leader of in vitro diagnostics, has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the VITROS^® Immunodiagnostic Products HIV Combo Assay (VITROS HIV Combo) for use on the VITROS^® 3600 Immunodiagnostic System.  In addition, Ortho also submitted PMA supplements for the VITROS^® Immunodiagnostic Products HBeAg Assay and VITROS^® Immunodiagnostic Products Anti-HBe Assay for use on the VITROS^® 3600 Immunodiagnostic System and VITROS^® 5600 Integrated System.

"We are committed to designing assays to help our laboratory customers diagnose infectious diseases as early as possible in the disease cycle, while also supporting labs in managing their workloads as effectively and efficiently as possible," said Robert Yates, Ortho's chief operating officer.  "By seeking to expand our clinical labs menu, and making existing immunoassays available on multiple VITROS Systems, we aim to help our customers achieve both of those goals." 

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

[i]  http://www.who.int/hiv/en/  
[ii] http://www.cdc.gov/std/treatment/2010/hiv.htm 
[iii] https://www.cdc.gov/hiv/statistics/overview/ataglance.html
[iv] http://www.who.int/mediacentre/factsheets/fs204/en/

SOURCE Ortho Clinical Diagnostics

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