One-third of Roche Diagnostics' molecular customer base has already purchased or ordered the COBAS AmpliPrep /COBAS TaqMan HIV-1 assay, just eight weeks after the assay received approval from the Food & Drug Administration to go to market.
Quick distribution to the market also allowed physicians to measure HIV patients' prognosis and monitor the effects of antiretroviral therapy within a month of FDA approval.
"This is most successful launch of a new molecular test at Roche Diagnostics," said Susan Zienowicz, Vice President of Molecular Diagnostics at Roche Diagnostics. "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."
In addition to the accuracy and speed provided by the fully automated, real-time PCR test, many customers were influenced to make the purchase because they did not need to re-baseline or recalibrate patients since our comprehensive trials have demonstrated a high correlation between the new COBAS AmpliPrep / COBAS TaqMan HIV-1 test and other HIV viral load methodologies.
Regardless of when a patient was diagnosed or the duration of treatment, the new dynamic range of this test delivers standard of care sensitivity (50 copies/mL) and quantitation between 48 copies and 10,000,000 copies.
Along with four other laboratories in the United States, Mount Sinai Molecular Laboratory participated in a study to cross-validate the analytical performance of the new fully automated platform across different sites in a real-life setting.