Laboratory Corporation of America® Holdings (LabCorp®) has announced an agreement to offer a HIV test for diagnostic use.
LabCorp is the first commercial laboratory to enter a supply agreement for Roche Diagnostics' COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, a real-time PCR test using an automated format that quantifies the amount of the virus in the blood from very high to very low levels.
The U.S. Food & Drug Administration (FDA) approved the test on May 11, 2007 for use in the United States. Doctors will use the information the test provides to establish a baseline HIV infection level before treatment of patients, as well as to monitor patients' responses during treatment.
"Our agreement to make available this state-of-the-art HIV test further illustrates LabCorp's continuing commitment to patient care and scientific leadership," said Myla P. Lai-Goldman, M.D., Executive Vice President, Chief Scientific Officer and Medical Director of LabCorp.
Lai-Goldman continued, "We're proud that we will be offering a test that will allow patients to receive treatment tailored to their particular level of infection, which will lead to more successful management of the virus. Furthermore, by fully automating sample preparation, amplification and detection in a standardized process, we will eliminate a number of manual steps and enhance the total quality process."
"We are very pleased that our new HIV test and automated platform will enable LabCorp, a recognized leader in clinical diagnostics, to continue its tradition of pioneering commercialization of new diagnostic technologies," said Daniel O'Day, President and CEO of Roche Molecular Diagnostics, the business area of Roche that developed the test.
"HIV remains a serious health issue in the U.S. and worldwide. We recognize that LabCorp's enthusiasm for bringing this test to the U.S. market quickly has important potential to benefit treatment monitoring for many of the more than 1 million HIV-infected patients across the nation,” O'Day added.