FDA Approves Roche’s Automated System for HBV Detection

Roche Molecular Diagnostics, a global provider of healthcare solutions, has declared that its COBAS AmpliPrep / COBAS TaqMan HBV Test v2.0 has received the approval from the U.S. Food & Drug Administration (FDA) for its utilization in the U.S. The patients undergoing hepatitis B virus (HBV) antiviral treatment are benefited by this new test which offers an automated method of estimating the HBV DNA present in their serum or blood.

Paul Brown, President and CEO of Roche Molecular Diagnostics has stated that the new HBV test helps the doctors to adopt the best methods in HBV patients care by offering a wide range of diagnosis, consistent viral load measurements and high sensitivity. He added that their automated system assures effective protection of every patient’s test result, thereby helping the doctors to make decisions with assured confidentiality.

According to Teresa Wright, Chief Medical Officer of Roche Molecular Diagnostics, viral load testing plays a major role in HBV antiviral therapy and the consistency and reproducibility attributes of Roche’s HBV test will enable them to increase the number of outcomes of HBV patients.

This new test can be employed on Roche's fully automated COBAS AmpliPrep/COBAS TaqMan System which links the COBAS AmpliPrep Instrument for automated preparation of samples and the COBAS TaqMan analyzer or the smaller COBAS TaqMan 48 analyzer for automated diagnosis and PCR amplification. This fully automated system works on "Sample in/results out" principle, thereby eliminating the need for manual interference between various phases of the test. It also features configuration options which offer modifiable solutions for throughput requirements. In order to avoid cross-contamination of the patients’ samples and the laboratories, each Roche’s test utilizes AmpErase enzymes.

This fully integrated system is utilized in more than 250 clinical labs across the United States.

Source: http://www.roche.com

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