Abbott has announced the filing of four pre-market approval applications (PMAs) with the US FDA seeking approval of automated hepatitis assays for use on Abbott’s ARCHITECT ® and AxSYM ®1 instruments. 

Abbott has filed a total of seven applications for automated hepatitis assays since November, 2005. The additional PMAs filed this year include HBsAg/Confirmatory for ARCHITECT; AxSYM AUSAB; AxSYM Core-M; and AxSYM Core.  Abbott Diagnostics’ PMAs submitted in 2005 include ARCHITECT Anti-HCV, ARCHITECT AUSAB, and AxSYM  HBsAg/Confirmatory.        

"We’re committed to bringing forward automated hepatitis solutions for our customers," says William Brown, PhD, vice president, Diagnostic Assays and Systems Development, Abbott.  "These filings clearly demonstrate our resolve to introduce a complete automated testing panel to the US market while advancing the state of the science in this important area."

Abbott already offers three automated hepatitis assays for use on its AxSYM platform:  AxSYM HAVAB, AxSYM HAVAB-M, and AxSYM anti-HCV.  In October, 2005, the FDA approved a hepatitis B test, PRISM ® HBcore, for use on the  PRISM system.  Additional PRISM hepatitis and retrovirus screening tests are currently under FDA review.