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GEN News Highlights : Oct 6, 2006

Gen-Probe’s Aptima HIV-1 RNA Qualitative Assay Obtained Approval for Clinical Use

Assay should be launched in November.
Gen-Probe received marketing approval for the Aptima® HIV-1 RNA qualitative assay. The assay is the first FDA-approved qualitative nucleic acid test (NAT), according to the company. Aptima will aid diagnosis of acute and primary HIV-1 infection and confirm HIV-1 infection in individuals whose specimen is repeatedly reactive for HIV-1 antibodies in the clinical.

Gen-Probe expects to launch the assay in November in conjunction with the Aptima HCV (hepatitis C virus) RNA qualitative assay.

The Aptima HCV assay may be used to detect HCV RNA in individuals with antibody evidence of HCV infection and evidence of liver disease, individuals suspected to be actively infected with HCV with antibody evidence, and individuals at risk for HCV infection with antibodies to HCV.

“We believe these two new qualitative viral products may fill a small yet important medical niche in the detection of two treatable but potentially life-threatening diseases, especially in light of new CDC guidelines that support increased testing for HIV and new scientific publications regarding hepatitis C,” comments Steve Kondor, vp of sales and marketing.