FDA Gives Bio-Rad the Go-ahead
Bio-Rad Laboratories, Inc. and the American Red Cross announced that the U.S. Food and Drug Administration (FDA) has notified Bio-Rad that it may proceed with its Investigational New Drug (IND) study for the Bio-Rad Dengue NS1 Ag microplate assay. The Red Cross will use the immunoassay to screen approximately 80,000 blood donations from Puerto Rico, where dengue currently is endemic.
The Dengue NS1 Ag test is an easy-to-perform assay for detection of dengue NS1 antigen in serum or plasma. Bio-Rad introduced the Dengue NS1 Ag test in 2006 as the first and only available dengue antigen detection test on the market. The test is currently used in over 40 countries throughout the world. Results of the IND study may open the doors for Bio-Rad to introduce the Dengue NS1 Ag test to U.S. markets. Bio-Rad Laboratories, 800-424-6723, http://www.bio-rad.com