& affiliate earns FDA clearance for rapid HBV antigen assay

July 17, 2001

16th July, 2001

Ortho-Clinical Diagnostics

WASHINGTON (Reuters Health) -Ortho-Clinical Diagnostics has received

clearance from the US Food and Drug Administration (FDA) to market a

hepatitis B surface antigen assay for the laboratory diagnosis of

individuals with acute or chronic hepatitis B virus (HBV), the &

affiliate announced on Friday.

The Raritan, New Jersey-based concern said that it received clearance to

market its Vitros Immunodiagnostic Products HBsAg assay, the second

infectious disease test to now be approved for use with its Vitros ECi

Immunodiagnostic System.

In total, the immunoassay system has now been approved to perform more than

26 analytes, including assays for thyroid function, reproductive health and

fertility, bone metabolism, anemia, metabolic functions, emergency

cardiology and oncology.

" The addition of this new test underscores the continuing commitment of

Ortho-Clinical Diagnostics to expanding and enhancing our immunodiagnostic

portfolio, " said Burzik, president of the company's American

division.

The Vitros HBsAg assay was approved for the qualitative in vitro detection

of hepatitis B surface antigen in human serum and plasma. In addition, the

assay was approved to screen pregnant women for hepatitis B infection to

identify neonates at high risk of acquiring HBV during the perinatal period.

Results from the Vitros HBsAg assay are available in as little as 37

minutes, allowing for the administration of hepatitis B immune globulin and

hepatitis B vaccine to the newborn within 12 hours as recommended by the US

Centers for Disease Control and Prevention (CDC), the company noted.

" Time to results is dramatically reduced with the Vitros HBsAg assay and

this test eliminates the need for batch testing which provides significant

efficiencies for the clinical laboratory, " observed DeLucia,

Ortho-Clinical Diagnostics' product director for infectious diseases.

Besides approval for the assay, the FDA clearance also included approval for

the Vitros Immunodiagnostic Products HBsAg Confirmatory Kit. This kit is

used with the Vitros ECi Immunodiagnostic System for the qualitative

confirmation of HBV.

The company noted that both approvals were granted within 178 days. Burzik

added that the rapid FDA response bodes well for the company's anti-HCV

assay, which the FDA just recently reviewed. Burzik said that the company is

optimistic " that its approval will be as expeditious. "

Outside the United States, the Vitros ECi Immunodiagnostic System has also

been approved for detection of hepatitis A as well as anti-HIV I/II.

July 17, 2001