30. December 2008FDA Approves Most Comprehensive System to Test Donated Blood for HIV, Hepatitis B & Hepatitis CThe United States Food & Drug Administration (FDA) approved a new nucleic acid test from Roche to screen donated blood for HIV-1 Group M RNA, hepatitis C RNA and hepatitis B DNA in a single, automated assay. more 15. December 2008New Roche Dual Target HIV-1 Test Approved for Use in European UnionRoche announced that its innovative dual-target HIV-1 test has received CE Mark certification, allowing it to be sold for clinical use in the European Union. more 08. December 2008Improved Testing for Hepatitis B Virus from RocheRoche Molecular Diagnostics announced that it has received CE Mark certification for its new COBAS® AmpliPrep / COBAS® TaqMan® HBV Test v2.0, allowing it to be sold for clinical use in the European Union. more 30. October 2008Roche receives FDA approval for Hepatitis C viral load test on its fully automated real-time PCR platformRoche Molecular Diagnostics announced that the U.S. Food & Drug Administration (FDA) has approved the COBAS® AmpliPrep / COBAS® TaqMan® HCV Test for use in the United States. The test uses Roche's proprietary real-time PCR technology to quantify the amount of Hepatitis C RNA in a patient's blood. more 04. September 2008FDA Approves First Hepatitis B Viral Load TestThe U.S. Food & Drug Administration (FDA) has approved the Roche COBAS® TaqMan® HBV Test, the first assay for quantitating Hepatitis B Virus DNA approved in the U.S. The test uses Roche's real-time PCR technology to quantify the amount of Hepatitis B virus DNA in a patient's blood. more 13. June 2008New Roche Chlamydia Test Approved for Use in European UnionRoche announced that its new test for detection of Chlamydia trachomatis has received CE Mark certification, allowing it to be sold for clinical use in the European Union. It is designed with a dual target approach to help ensure reliability of test results even when mutations occur in the bacteria's cryptic plasmid DNA. more 02. June 2008Roche Signs Exclusive Distribution Deal with DxS for K-RAS and EGFR Cancer Mutation TestsRoche and DxS Ltd. have signed an exclusive distribution agreement for the DxS TheraScreen K-RAS Mutation Test and TheraScreen EGFR 29 Mutation Test. The tests are intended, when considered with other clinically relevant factors, to aid doctors in identifying suitable patients likely to benefit from a specific cancer therapy.more |