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MARKETING APPLICATIONS FOR HIV SCREENING AMPLIFICATION TESTS ARE LIKELY TO REQUIRE VALIDATION DATA FROM 7,000 SAMPLES, FDA STAFFER TELLS CONFERENCE

This article was originally published in The Gray Sheet

Executive Summary

Marketing applications for nucleic acid-based amplification assays for HIV screening in blood bank settings will likely require validation data from a "large range of specimens, probably in the range of 7,000," Indira Hewlett, PhD, chief of the Center for Biologics Evaluation and Research's Laboratory of Molecular Virology, told a Sept. 26-28 FDA conference.
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