T Cell Sciences regulatory update

The Cambridge, Mass., company agreed to do an additional clinical study of its TRAx CD4 Elisa immunoassay in 400 blood samples that are HIV-positive, as part of the 510(k) application first submitted to the FDA in October 1992.

The immunoassay, which measures CD4 protein and gives a color change to quantify numbers of CD4 cells present, is being tested to show equivalence to flow cytometry to monitor progression of HIV infection. ...