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Tag Archives: Roche—

Health Canada approves Roche’s HPV test, 7/14

July 2014—Health Canada approved Roche’s Cobas 4800 HPV Test for use as a first-line primary screening test for cervical cancer in women 25 and older. Roche also launched the fully automated CINtec Plus test to improve the detection and early intervention of precancerous cervical disease. The Health Canada–approved CINtec Plus cytology test helps identify women with high-grade precancerous cervical lesions who need immediate colposcopy.

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Streamlined workflow for HPV test, 9/13

The FDA in June approved a workflow process for Roche Diagnostics’ Cobas HPV test that allows sample processing from the primary sample collection vial after it has been used for cytology (Pap) testing. The approval allows labs to load the same vial used for a ThinPrep Pap test directly onto Roche’s Cobas 4800 system for high-risk HPV and individual HPV ...

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Intelligent lab automation solution, 9/13

Roche’s Cobas 8100 automated workflow series is an advanced system designed to automate many routine tasks to help diagnostic laboratories increase efficiency, reduce expenses, and maximize patient safety. Through intelligent robotics, the Cobas 8100 series automatically prepares blood samples for immediate testing and post-analytical processing, providing high-speed processing of up to 1,100 samples per hour. The system offers dynamic and ...

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Streamlined workflow for Roche HPV test, 8/13:86

The FDA has approved a workflow process for Roche Diagnostics’ Cobas HPV test that allows sample processing from the primary sample collection vial after it has been used for cytology (Pap) testing. Labs can load the same vial used for a ThinPrep Pap test directly onto the Cobas 4800 system for high-risk HPV and individual HPV 16 and 18 genotype ...

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Erlotinib tablets and EGFR mutation test, 7/13:104

The FDA has approved Roche Diagnostics’ Tarceva (erlotinib) tablets for the initial treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors have certain epidermal growth factor receptor (EGFR)-activating mutations as detected by an FDA-approved test. The FDA also approved Roche’s Cobas EGFR mutation test. In the United States, Tarceva is already approved, irrespective of histology or biomarker ...

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Next-gen HCV test, 4/13:86

Roche has received FDA approval for its Cobas AmpliPrep/Cobas TaqMan HCV test, v2.0. The next-generation viral load test is for use in the management of patients with chronic hepatitis C virus infection. The test provides a novel dual-probe approach, for an extra layer of protection in detecting and quantifying the virus and is designed to accurately determine the amount of HCV RNA to assess a patient’s response to antiviral therapy.

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