T Cell Sciences Inc. said Monday it submitted more data to support its501(k) submission for marketing clearance of its TRAx CD4 Test Kitfor CD4 cell enumeration. The Cambridge, Mass., company originallyfiled for FDA approval of the product in October 1992.Alan Tuck, president and CEO of T Cell Sciences, told BioWorld theamended 501(k) includes data from a new clinical trial testing onlythose infected with HIV, and comparing the TRAx results to thoseobtained with flow cytometry. Tuck said the correlation coefficient of89 percent is consistent with correlations of 89 percent to 95 percentseen in the company's earlier trials."We think this is a very complete (amended) submission proving thebenefits of TRAx," Tuck told BioWorld. "It's not only equivalent toflow cytometry, but it has some positive things that will make it easierfor the customer." Among those, he said, are that flow equipment is notneeded, that samples can be run up to seven days, that samples can befrozen and tested up to a year later, and that TRAx is more precise thatflow cytometry.Tuck said there are 500 sites in the U.S. running flow cytometry."We'll be able to expand that to 5,000 sites that already have theequipment and training to run ELISA- (enzyme linked sandwichimmunoassays) based tests." _ Jim Shrine
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