Bio-Rad Laboratories and the American Red Cross, today announced that the FDA, Center for Biologics Evaluation and Research, 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.
"Transfusion-transmitted dengue infections are a potential threat for blood recipients in Puerto Rico," said John Goetz, Bio-Rad Vice President and Group Manager Clinical Diagnostics. "Detection of the dengue NS1 antigen in patients’ sera has proven to be a superior method for early diagnosis of a dengue infection."