16. October 2007Japanese Red Cross selects Roche as partner for nucleic acid screening of entire Japanese blood supplyThe Japanese Red Cross has selected Roche as supplier for next-generation nucleic acid screening of the country’s 5 million annual blood donations. Nucleic acid testing (NAT) is a highly sensitive technology that can improve blood safety by detecting viral infections other donor screening methods may miss.more 28. August 2007FDA Approves New Roche West Nile Virus Blood Screening TestRoche Diagnostics announced that the US Food & Drug Administration (FDA) approved its biologics license application for the company's test for direct detection of West Nile Virus in donated human blood and plasma.more 10. May 2007Highly sensitive and accurate Roche HIV-1 Test approved by FDARoche announced that the U.S. Food & Drug Administration (FDA) has approved its new HIV-1 test for diagnostic use in the United States. The highly accurate Cobas AmpliPrep/Cobas TaqMan HIV-1 Test is the first fully automated HIV-1 diagnostic tool using real-time PCR technology in the US.more 07. March 2007FDA Accepts for Review New Roche Diagnostics Blood Screening TestRoche Diagnostics announced that the United States (U.S.) Food & Drug Administration has accepted for review its application for a new test designed to detect a broad range of human immunodeficiency virus (HIV) and viral hepatitis infections in donated blood and plasma. more 05. March 2007FDA Accepts for Review Two Roche Diagnostics HPV TestsRoche Diagnostics announced that the U.S. Food & Drug Administration has accepted for review its applications for two human papillomavirus (HPV) tests. The Amplicor HPV Test is designed to enable accurate detection of 13 of the more common high-risk HPV genotypes in standard clinical samples. more 17. January 2007Roche Diagnostics Submits West Nile Virus Blood Screening Test to FDARoche Diagnostics announced today that it has submitted its Biological License application for the cobas TaqScreen WNV Test to United States Food & Drug Administration (FDA).
more 15. January 2007Roche Diagnostics Submits Hepatitis C Viral Load Monitoring Test to FDARoche Diagnostics announced today that it has submitted its automated test for Hepatitis C viral load monitoring to the U.S. Food & Drug Administration (FDA) for review. more |