Nucleic acid testing (NAT) is a new, highly sensitive testing approach for improving the safety of the world’s blood supply. Moving quickly from concept to commercialization, Chiron and its collaborator, Gen-Probe Incorporated, developed the Procleix System, a NAT assay and instrument system, in just three years. The Procleix System has proven to significantly reduce the risk of contracting hepatitis C and HIV from blood transfusions. Because NAT directly detects infectious agents in the blood during the very early stages of infection, it can reduce the time of detection by more than 70 percent in the case of HCV and 50 percent for HIV-1. As NAT testing is adopted in major markets throughout the world, the Procleix HIV-1/HCV Assay is rapidly gaining acceptance as a leading product for the blood screening market.
Every year approximately 50 million blood donations are tested in North America, the European Union, and Asia-Pacific, representing a potential market of $500 million or more. In the U.S., the Procleix HIV-1/HCV Assay and instruments were approved by the Food and Drug Administration (FDA) in February 2002. Chiron also continued its global rollout of the Procleix system in France and Italy during the past year. In addition, the company is working to introduce the system into new markets in Europe, South America, and Asia.
Chiron and Gen-Probe are developing additional Procleix assays to expand the value of their innovative NAT technology. The companies are currently working on a new assay for the hepatitis B virus (HBV), which they plan to include in a triplex assay for the simultaneous detection of HIV-1, HCV, and HBV. The companies are also responding to needs expressed by the blood banking community by initiating development of NAT assays for parvovirus B19 and hepatitis A.
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