White Papers for Food and Drug Administration (FDA)

Looking Back Robbins Gioia Helps Nations Largest Blood Supplier Track Down Hepatitis C

Robbins-Gioia

In 1998, the Food and Drug Administration issued regulatory guidance to all blood services organizations directing them to perform a records lookback on donors who have tested positive for hepatitis C since 1990. Although HIV/AIDS remains the most feared blood-borne virus, the hepatitis C virus is actually a bigger killer. This liver disease affects more than 4 million people, is often asymptomatic, and after many years is fatal. For years there was no effective way to test for the virus. In 1990, however, Chiron, a leading biotechnology company, developed the first process capable of screening donated blood for the hepatitis C virus. The test was refined through three iterations before the FDA gave the go-ahead to industry to perform the Hepatitis C Virus (HCV) lookback. The organization had hoped to centrally manage the project with the aid of a national database. Robbins-Gioia, however, immediately decided to set up a back-up manual plan—just in case.

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