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Celera Genomics receives approval of CE Mark for new PCR HCV genotyping test
By E. Janene Geiss
Philadelphia, July 25 - Celera Genomics said Tuesday that a highly accurate and sensitive new test used for genotyping of the hepatitis C virus has received approval for a CE Mark on the RealTime HCV Genotype Assay, which allows it to be marketed in the European Union as a diagnostic product.
This is the first real-time test for genotyping the hepatitis C virus to obtain regulatory approval for commercial sale in Europe and is designed for use on the automated ABI Prism 7000 real-time PCR (polymerase chain reaction) system from Applied Biosystems, according to a company news release.
The test was developed and will be sold through Celera's alliance with Abbott, officials said.
Real-time PCR enables the production of large quantities of DNA from clinical samples in a short period of time, making it possible to detect low levels of a virus's genetic material.
The new Abbott RealTime HCV Genotype test automates key steps of the process, from PCR to data analysis and generation of a results report, allowing laboratories to process molecular tests efficiently and accurately, officials said.
The new CE Mark approval expands the menu of tests available to European laboratories working in hepatitis C infection, complementing the hepatitis C quantitative viral load test currently available for use on the Abbott m2000 system.
A version of the hepatitis C genotyping test adapted to the m2000 system is under development at Abbott.
Celera Genomics is an Applera Corp. business group. The Rockville, Md., biotechnology company uses proprietary genomics and proteomics discovery platforms to develop molecular diagnostic products.
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