Roche Executes HIV Viral Load Monitoring Test
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.
"When the five different sites met to compare results, I was happy to see that all the results were extremely consistent across the laboratories, even when different system configurations and different sample types were used," said Dr. Josephine Wu, Assistant Director of the Molecular Pathology Laboratory at Mount Sinai Medical Center, one of the first US laboratories to purchase the COBAS(R) AmpliPrep(R) /COBAS(R) TaqMan(R) HIV-1 system.
American quick acceptance of the test builds on European adoption, which has helped Roche obtain a majority share of the European viral load testing market for HIV.
"Thanks to our 11 years of experience in HIV globally, Roche Diagnostics had monitored genetic isolates emerging from around the world," said Dr. Tadd Lazarus, Medical Director at Roche Diagnostics. "We have designed the genetic coverage of our assay so that it meets the needs of clinicians, follows monitoring guidelines and reflects most current knowledge of genetic variations. Our newest HIV-1 viral load test continues to deliver full Group M subtype coverage, including the rare non-B subtypes."