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By Todd Zwillich
GAITHERSBURG, Md. Mar 16 (Reuters Health) - An expert advisory panel unanimously recommended on Thursday that the Food and Drug Administration adopt stricter sensitivity standards for hepatitis B virus screening tests used on the nation's blood supply.
"We can't assure that the risk in the donor population 10 years from now will be (low) as it is today. A more sensitive and specific test would certainly be an advantage", said Dr. Kenrad E. Nelson, chair of the FDA's Blood Products Advisory Committee.
The 14-0 decision, if accepted by the FDA, would clear the way for a new generation of tests, including hepatitis B surface antigen tests (HBsAg) and HBV nucleic acid tests (NAT), while simultaneously driving currently licensed but less sensitive tests from the market. Hepatitis B is a liver-damaging virus that can be spread with sexual contact, contaminated blood or from sharing IV needles.
Test manufacturers hailed the decision, saying it would enable them to push forward with new HBV tests without the threat of older ones crowding out innovation.
"The decision clearly shows that FDA is focused on the new technologies," said Dr. Bruce Phelps, vice president of research and development for HBV NAT maker Chiron, told Reuters Health. The company is one of three currently attempting to license NAT screens in the US.
American experts are eager to bring new hepatitis B surface antigen and nucleic acid tests to market in the US. The tests have been used with what most see as success in Europe and Japan for up to 2 years but remain unlicensed here. However, controversy remains as to which of the two testing methods is superior for efficiently and cheaply screening out blood infected with hepatitis B virus.
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