Cambridge Biotech Corp. regulatory update

CBCXE's PLA for its Human T-Lymphotropic Virus Type I (HTLV-I)(rp21e enhanced) immunoassay, was approved by the FDA as a qualitative screen for donated blood to prevent the transmission of HTLV-I and as an aid in the clinical diagnosis of HTLV-I-related diseases, including adult T cell leukemia and certain neurological disorders.

The assay supplements viral lysate with recombinant p21 protein to increase sensitivity and specificity. In clinical trials, the test showed an overall estimated sensitivity of 99.54-100 percent and overall estimated specificity of 99.7-99.9 percent, the Worcester, Mass., company said. ...