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In Brief: ChemTrak

This article was originally published in The Gray Sheet

Executive Summary

ChemTrak: Submits premarket approval application to FDA for its home HIV test kit, making it the second firm, along with J&J subsidiary Direct Access Diagnostics, to seek agency approval for such a product. The ChemTrak test involves pricking the finger with a lancet, placing two drops of blood on a special paper, and then sending the sample in a postage-paid mailer to ChemTrak for testing. The product was obtained by ChemTrak through the acquisition of Coonan Clinical Labs ("The Gray Sheet" Jan. 2, p. 5), which was completed on Feb. 3...
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