According to Roche Diagnostics (Basel, Switzerland), the introduction of its newly approved HIV-1 test to the United States market is the most successful launch of a molecular test in the company’s history. Within a few months of its May approval, approximately one-third of Roche Diagnostics’s U.S. molecular customers had purchased or ordered the test.
The test, known as the Cobas AmpliPrep/Cobas TaqMan HIV-1 test, monitors HIV-1 viral replication and quantitates the virus present in patient samples over a dynamic range between 48 copies and 10,000,000 copies, a much wider spectrum than had been previously been available to physicians.
Approved by the FDA in May, the test is the first fully automated HIV-1 diagnostic tool using real-time PCR technology in the United States. The fully automated technology also delivers results relatively quickly—within approximately eight hours. A recent study conducted by Medical Laboratory Bremen (Bremen, Germany) concluded that the test can save laboratories 30 minutes of workflow time and can process up to 50% more samples in a single day’s shift, compared with Abbott’s RealTime HIV test.
The Roche test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy during the course of treatment. A primary goal of therapy is achieving and maintaining viral load that is below the limits of detection of approved molecular diagnostic tests. Analysis of 18 trials with over 5,000 participants with viral load monitoring had shown a significant association between a decrease in plasma viremia and improved clinical outcome.
The test is designed for use on an automated platform that combines the Cobas AmpliPrep instrument for automated sample preparation and the Cobas Taq- Man analyzer or smaller Cobas TaqMan 48 analyzer for automated real-time PCR amplification and detection. Configuration options also include docked instruments for “sample in/results out” testing that eliminates manual intervention between steps.
The test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. The test is not intended for use as a screening test for the presence of HIV-1 in blood or blood products or as a diagnostic test to confirm the presence of HIV-1 infection.
Over the summer,Oregon Medical Laboratories(OML; Springfield, OR) became the first regional reference laboratory on the West Coast to perform the test. According to OML, it will allow the lab to double its HIV testing capacity and reduce the time it takes to get results for a patient’s HIV viral load.
As a Roche Molecular Center of Excellence, OML had access to the test as one of four participants in a nationwide study of its effectiveness. Currently, 21-yearold OML analyzes 5,500 HIV tests annually in Washington, Oregon, and Alaska. OML is Oregon’s largest medical laboratory, performing approximately 7 million tests in 2006.
Meanwhile, on October 2, Roche announced its appointment of Jürgen Schwiezer as CEO of its Roche Diagnostics division. Schwiezer will assume the role on Jan. 1, 2008, succeeding Severin Schwan, who will replace Franz B. Humer as CEO of the Roche Group in March of 2008. Schwiezer is currently president of Roche Diagnostics for Europe, Middle East, Africa, and Latin America. In 2006, Roche’s Diagnostics division posted sales of 8.7 billion Swiss francs (approximately $7.3 billion, at current exchange rates).