Roche Diagnostics announces ‘successful launch’ of Cobas HIV viral load tests

Roche Diagnostics has announced the most successful launch of a new molecular test by the company with the recent launch of its Cobas AmpliPrep /Cobas TaqMan HIV-1 assay.

The firm has reported a speedy supply to the market in the eight weeks since the test was approved by the US Food and Drug Administration, with this rapid distribution facilitating the use of the test by physicians within a month of its regulatory endorsement.

Roche notes that the dynamic range of the test offers quantitation of between 48 and ten million copies, with a sensitivity of 50 copies per millilitre, irrespective of the time of patient diagnosis or duration of treatment.

Susan Zienowicz, vice-president of molecular diagnostics at Roche Diagnostics, said: “Not only have we experienced unprecedented market acceptance of the new HIV-1 assay, but we were able to quickly get the assay into the hands of our customers, who then immediately made this latest technology available to their customers.”

Dr Josephine Wu, assistant director of the Molecular Pathology Laboratory at Mount Sinai Medical Centre, a US laboratory that has purchased the Cobas AmpliPrep /Cobas TaqMan HIV-1 system, commented that the results across its five sites were consistent, despite different configurations and sample types.

In May 2007, Roche Diagnostics reported that these molecular tests combine innovative options for sensitive HIV testing with full state-of-the-art automation of procedures.