Gen-Probe Incorporated announced that the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration has granted two new intended uses for Gen-Probe's licensed nucleic acid test (NAT) for the detection of human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) in donated blood.
The HIV-1/HCV assay, which is marketed by Chiron Corporation under the Procleix name, has now been approved for screening voluntary donations of source plasma and for use as a discriminatory HIV (dHIV) test for clinical diagnosis. The HIV-1/HCV assay was first approved for commercial sale for screening donated blood in February 2002.
Under the Company's collaboration agreement with Chiron, Procleix-branded assays are sold exclusively by Chiron to blood centers conducting NAT on donated blood or plasma intended for transfusion or further processing prior to administration to patients. The Procleix-branded assay is not sold to clinical diagnostic laboratories.
Any revenues expected from sales of the Procleix assay for the two additional intended uses were included in the Company's prior 2002 and 2003 year-end earnings guidance.
"We sought the voluntary source plasma claim in response to a request from the American Red Cross," said Henry L. Nordhoff, chairman, president and chief executive officer. "This extended approval on our blood screening license is indicative of Gen-Probe's ability to obtain regulatory approvals to meet the needs of our customers and to execute our strategy to help ensure the safety of the world's blood supply. Additionally, we see the significant benefits of a diagnostic NAT HIV test for customers outside of the blood banking market and are now pursuing a strategy to commercialize the dHIV test as a stand-alone diagnostic."