Roche Diagnostics' Cobas Integra 800 Tina-quant HbA1cDx assay is the first of its kind to be cleared by FDA for use in diagnosing diabetes.
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Roche Diagnostics sits at No. 1 on the list of the top 10 molecular diagnostics companies based on revenue. Its diverse molecular diagnostics product portfolio spans oncology, virology, microbiology, and blood screening. The company also owns Ventana Medical Systems, a leader in the tissue diagnostics space, and is making a push in the budding area of genomics.
This spring, Roche Diagnostics scored a coup with FDA clearance of its Cobas Integra 800 Tina-quant HbA1cDx assay for diagnosing diabetes. Other HbA1c tests on the market have been cleared for monitoring blood glucose levels, but the Tina-quant HbA1cDx assay is the first the agency has allowed to be marketed for diagnosing diabetes.
Roche’s diabetes care products have been plagued by poor sales of late, but this test gives the company an early lead in tapping the estimated 7 million undiagnosed diabetics. Roche Diagnostics reported 3% sales growth overall for the first half of 2013.