Japanese Red Cross selects Roche as partner for nucleic acid screening of entire Japanese blood supply

Unique cobas test system for simultaneous detection of HIV and Hepatitis in donated blood

Roche announced today that the Japanese Red Cross (JRC) 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. The tests will be performed on Roche’s fully integrated and automated cobas s 401 instrument with the cobas TaqScreen MPX Test. The test is able to simultaneously detect HIV-1 (Groups M & O), HIV-2, Hepatitis B and Hepatitis C viruses in donated blood.

FDA Approves New Roche West Nile Virus Blood Screening Test

Automated test helps ensure safety of blood supply by detecting virus earlier in infection cycle.

Roche Diagnostics announced that the US Food & Drug Administration (FDA) today approved its biologics license application for the company's test for direct detection of West Nile Virus in donated human blood and plasma. West Nile virus, which can cause serious health issues, is transmitted to humans most often through mosquito bites, but can also less commonly be transmitted by transfusion of infected blood or blood products. The test, called the cobas TaqScreen West Nile Virus Test, enables detection of the virus earlier in the infection cycle in donors who may show no symptoms of disease. According to the CDC, blood screening centers across the United States identified 340 donors whose blood tested positive for West Nile Virus in 2006 and 23 to date in 2007.

Highly sensitive and accurate Roche HIV-1 Test approved by FDA

Automated test enables faster results for doctors monitoring treatment response

Roche announced today 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. It provides a broader range of viral load data than earlier generation tests, quantifying the amount of virus in the blood from very high to very low levels. With the test, labs can deliver highly accurate results faster - a decisive advantage for doctors monitoring how well a chosen therapy is working for the patient.

FDA Accepts for Review New Roche Diagnostics Blood Screening Test

Automated test is designed to detect broader range of HIV and hepatitis in a single multiplex assay.

Roche Diagnostics announced today 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. The test, called the cobas TaqScreen MPX Test, uses real-time PCR to detect HIV type 1 (Groups M & O), HIV type 2, hepatitis C virus (HCV), and hepatitis B virus (HBV) in a single multiplex assay. The test is designed for use on Roche's newly automated, modular cobas s 201 platform. Nucleic acid amplification technologies such as PCR allow earlier and more specific detection of active infections in donated blood than earlier generation serology tests, helping to ensure a safer blood supply and retention of donors who would otherwise be deferred.

FDA Accepts for Review Two Roche Diagnostics HPV Tests

Tests are designed to detect and genotype high-risk HPV types which, if present in persistent infections, can progress to cervical cancer

Roche Diagnostics announced today that the United States (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. The Linear Array HPV Genotyping Test is designed to identify which of the 13 high-risk HPV genotypes are present in a sample. Persistent infection with HPV is the principal cause of cervical cancer and its precursor, cervical intraepithelial neoplasia.

Roche Diagnostics Submits West Nile Virus Blood Screening Test to FDA

Automated test uses real-time PCR to detect West Nile Virus in donated blood & plasma

Roche Diagnostics announced today that it has submitted its Biological License application for the cobas TaqScreen WNV Test to United States Food & Drug Administration (FDA. The test is designed to detect West Nile Virus in donated blood and plasma. The agency will review the application to determine whether the test can be marketed in the U.S.

Roche Diagnostics Submits Hepatitis C Viral Load Monitoring Test to FDA

Test designed to give doctors highly accurate results and to improve workflow efficiency for labs

Roche 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. The FDA will review the application to determine whether the test can be marketed for diagnostic use in the United States. The test, called the COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, is designed to provide highly accurate information about the quantity of Hepatitis C virus in a patient's blood, from very high to very low levels. This type of diagnostic, called "viral load testing," is a key measure of how well a patient infected with Hepatitis C is responding to drug therapy.