Abbott Laboratories announced that it has received approval from the US Food and Drug Administration (FDA) for 11 diagnostic assays for hepatitis, prostate specific antigen (PSA) and alpha-fetoprotein (AFP). The tests are performed on Abbott's Architect, AxSYM and IMx immunoassay instrument systems.
"The determination of substantial conformity with the Quality System Regulation in our Lake County, Ilinois, manufacturing operations in December 2003 was a key step in obtaining these approvals, providing new products to advance US laboratory automation for diagnostic testing," said Joseph Nemmers, senior vice president, diagnostic operations, Abbott.
Nemmers added, "With these approvals, we can proceed with the activities that lead up to market introduction for our customers in the US These activities are carried out in our improved Quality System, which remains our focus for ongoing quality improvement and regulatory compliance. We are prioritizing the hepatitis and PSA assays on the AxSYM instrument, and anticipate bringing these assays to the US market over the next six months."
The products approved include AxSYM HCV, AxSYM HAVAB, AxSYM HAVAB-M, Architect Total PSA, AxSYM Total PSA, IMx Total PSA, Architect Free PSA, AxSYM Free PSA, IMx Free PSA, Architect i2000 AFP and Architect i2000SR AFP.
Two of the hepatitis assays (HAVAB and HAVAB-M) are used to aid in the diagnosis of infection by the hepatitis A virus (HAVAB and HAVAB-M). One hepatitis assay (HCV) is used for the qualitative detection of antibodies to the hepatitis C virus. The three Total PSA tests are used to aid in the diagnosis and management of patients with prostate cancer. The three Free PSA tests, in conjunction with Total PSA results, can be used as an aid in discriminating between prostate cancer and benign disease. The two AFP tests are used in testicular cancer management and aid in the detection of fetal open neural tube defects.