DevicePMAs@therightstef:P020022_S000 JSONTXT 11 Projects

Approval for the bayer versant hcv rna 3.0 assay (bdna). The device is indicated for: the versant hcv rna 3.0 assay (bdna) is a signal amplification nucleic acid probe assay for the quantitation of human hepatitis c viral rna (hcv rna) in the serum or plasma (edta and acd) of hcv-infected individuals using the bayer system 340 bdna analyzer. Specimens containing hcv genotypes 1-6 have been validated for quantitation in the assay. The versant hcv rna 3.0 assay is intended for use as an aid in the management of hcv-infected patients undergoing anti-viral therapy. The assay measures hcv rna levels at baseline and during treatment and are useful in predicting non-response to hcv therapy, and are predictive of non-sustained virological response. The results from the versant hcv rna 3.0 assay (bdna) must be interpreted within the context of all relevant clinical and laboratory findings. Assay performance characteristics have been established only for individuals treated with interferon alfa-2b plus ribavirin. No information is available on the assay predictive values when other therapies are used.