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This article was originally published in The Gray Sheet

Executive Summary

Firm's Hepatitis C Check at-home testing and counseling service will be launched in June at a price of under $70 following approval of a premarket approval application, announced April 29. The first over-the-counter, at-home blood collection/mail-in testing service for hepatitis C, the product is the second at-home test to be offered by the Hoffman Estates, Illinois firm alongside its HIV test. Hepatitis C infects an estimated 4 mil. people in the U.S. each year. The approval coincides with HHS' HCV lookback program, which requires notification of recipients of transfusions and blood products during 1988-1992 that they may have been exposed to the virus
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