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DiaSorin Hepatitis B Tests Need Clearer Indication Of "High-Risk" Population

This article was originally published in The Gray Sheet

Executive Summary

DiaSorin needs to distinguish between specific subgroups of high-risk patient populations in labeling of its ETI Plus line of in vitro diagnostic hepatitis B serological marker assays, FDA's Microbiology Devices Advisory Panel agreed in recommending six assays for approval at a Jan. 20 meeting in Rockville, Maryland.

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