FDA Approves Most Comprehensive System to Test Donated Blood for HIV, Hepatitis B & Hepatitis C

Advanced test for increased blood safety is first to add the detection of HIV-1 Group O RNA and HIV-2 RNA

The United States Food & Drug Administration (FDA) today 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. The test, called the cobas TaqScreen MPX Test for use on the cobas s 201 system, is a qualitative in vitro test for comprehensive single-assay detection of HIV-1 Group M RNA, HIV-1 Group O RNA, HIV-2 RNA, hepatitis C Virus RNA and hepatitis B Virus DNA in human plasma. The test, which is not intended for use as an aid in diagnosis, is designed to further increase the safety of blood supplies by identifying infections earlier than traditional serology tests.

New Roche Dual Target HIV-1 Test Approved for Use in European Union

Extra confidence and security with an innovative Roche solution

Roche announced today 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. The COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 utilizes a unique design to simultaneously amplify and detect two separate regions of the HIV-1 genome. This approach provides reliable test results even when mutations are present. The test uses Roche's proprietary fully automated real-time PCR technology to quantify the amount of HIV-1 RNA in a patient's blood.

Improved Testing for Hepatitis B Virus from Roche

A sensitive and fully automated platform improves viral load testing in serum and plasma

Roche Molecular Diagnostics announced today 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. This highly sensitive test offers Roche's fully automated real-time PCR technology to achieve a broad dynamic range for the quantitative detection of hepatitis B virus (HBV) DNA in patient plasma and serum. According to the World Health Organization, approximately 2 billion people worldwide and about 350 million live with chronic HBV infection and are at risk of developing end stage liver disease and liver cancer.

Roche receives FDA approval for Hepatitis C viral load test on its fully automated real-time PCR platform

Improved laboratory efficiencies and standardization to personalize patient care

Roche Molecular Diagnostics today 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. Physicians use Hepatitis C viral load testing results to establish a baseline level of hepatitis C infection and to serially monitor viral load levels and treatment effectiveness in patients on therapy.

FDA Approves First Hepatitis B Viral Load Test

Another Roche first in TaqMan® real-time PCR testing for the diagnostic lab

The 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. Doctors may use viral load testing results to establish a baseline level of infection and during treatment as an aid in assessing individual responses to therapy.

New Roche Chlamydia Test Approved for Use in European Union

Test offers more reliable detection of Chlamydia trachomatis, the most commonly reported sexually transmitted disease in Europe.

Roche announced today 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. According to Eurosurveillance, a leading independent scientific journal, Chlamydia trachomatis is the most commonly reported sexually transmitted disease in Europe. Although it often causes no symptoms, Chlamydia can, if left untreated, lead to complications such as pelvic inflammatory disease or infertility in women.

Roche Signs Exclusive Distribution Deal with DxS for K-RAS and EGFR Cancer Mutation Tests

Tests identify genetic mutations that can affect patient response to certain cancer drugs

Roche 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 based on their mutation status.