FDA Approves Two Ortho Clinical Diagnostics Specialty Hepatitis B Assays

Newswise — Raritan, NJ (September 14, 2017) – Ortho Clinical Diagnostics (Ortho), a global leader of in vitro diagnostics, has received approval from  the  U.S. Food and Drug Administration (FDA) for Ortho’s VITROS® Immunodiagnostic Products HBeAg Assay and the  VITROS®  Immunodiagnostic Products Anti-HBe Assay for use on Ortho’s VITROS® 3600 Immunodiagnostic System and Ortho’s VITROS® 5600 Integrated System.  

Both assays, currently available on Ortho’s VITROS® ECi/ECiQ Immunodiagnostic Systems in the US, are used as an aid in diagnosis of hepatitis B infection in individuals with acute or chronic hepatitis B or recovery from hepatitis B infection.  This achievement allows customers the ability to consolidate all hepatitis tests onto Ortho’s single high-throughput VITROS® System, enabling them to better manage large volumes of diagnostic tests.

“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.  “The FDA’s approval of our hepatitis B assays for use on our VITROS® automated analyzers is an important step toward achieving those goals.”  

According to the CDC, millions of Americans have chronic viral hepatitis and most of them do not know they are infected.i   An estimated 240 million people worldwide are currently living with chronic hepatitis B, a life-threatening infection of the liver.ii    

Ortho has a long legacy in and commitment to the diagnosis of different forms of hepatitis.  In 1989, Ortho introduced the first test for the detection of antibodies to hepatitis C. In 2000, Ortho released the first commercially available test for the direct detection in blood and plasma of hepatitis C core antigen, a marker of early infection in hepatitis C-infected individuals. Since then, Ortho has expanded its leadership in hepatitis testing by developing a growing portfolio of tests for Hepatitis A, B, and C.   The introduction of Ortho’s VITROS® Anti-HBe and HBeAg on  VITROS®  3600 and 5600 Systems complements the other hepatitis tests already available on  VITROS®  3600 and 5600 Systems: 

VITROS® Immunodiagnostic Products HAV IgM
VITROS® Immunodiagnostic Products HAV Total
VITROS® Immunodiagnostic Products Anti-HBc
VITROS® Immunodiagnostic Products Anti-HBc IgM
VITROS® Immunodiagnostic Products Anti-HBs Quantitative
VITROS® Immunodiagnostic Products HBsAg
VITROS® Immunodiagnostic Products HBsAg Confirmatory
VITROS® Immunodiagnostic Products Anti-HCV


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 100 countries, Ortho’s high-quality products and services enable health care professionals to make better-informed treatment decisions. Ortho brings sophisticated testing technologies, automation, and 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
PR-02991