Genetically Engineered Clotting Solution Approved
FRIDAY, Jan. 18 -- The first clotting solution derived from recombinant DNA technology has been approved by the U.S. Food and Drug Administration to help stop small blood vessels from bleeding after surgery.
Recothrom, made by Seattle-based ZymoGenetics Inc., is a topical solution made from Chinese hamster ovary cells that have been genetically modified to produce human thrombin, a protein involved in blood clotting.
The hamster cells are tested for known infectious agents and are subjected to processes designed to thwart viruses, the FDA said.
In clinical testing involving 411 people, Recothrom met a primary benchmark of controlling bleeding within 10 minutes. It was as effective as an approved thrombin solution derived from cattle plasma, the agency said.
There's more about this approval from the FDA.
Posted: January 2008