NEW YORK (GenomeWeb News) – The Europen Union awarded the CE Mark to Celera Genomics' hepatitis C virus genotyping test, parent Applera said today.
Celera developed the RealTime HCV Genotype Assay with Abbott. It will be sold as part of this alliance. The test is designed to be used on Applied Biosystems' PRISM 7000 PCR system.
Called the Abbott RealTime HCV Genotype test, it complements the HCV quantitative viral load test available on Abbott’s m2000 system.
The regulatory approval allows the genotype assay to be sold in the European Union as a diagnostic product. This is the first real-time test for genotyping the HCV virus to obtain regulatory approval for commercial sale in Europe, Applera said.