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Monogram Biosciences, Inc. (Nasdaq: MGRM) announced that guidelines issued by the Department of Health and Human Services (DHHS) recommend that a co-receptor tropism test, such as Monogram's Trofile(TM) assay, should be performed whenever the use of a CCR5 inhibitor is being considered and might also be considered for patients who exhibit virologic failure on a CCR5 inhibitor. The Panel on Antiretroviral Guidelines for Adult and Adolescents guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents, Department of Health and Human Services, January 29, 2008, were developed by a working group of the Office of AIDS Research Advisory Counsel, the National Institutes of Health advisory body on HIV research and treatment policy and initiatives. These guidelines follow the FDA's instructions on Selzentry's label, which call for tropism testing prior to prescribing the drug. Pfizer's Selzentry(TM) (maraviroc) is the first CCR5 inhibitor to receive FDA approval. "The Office of AIDS Research recommendations and DHHS guidelines underscore the importance of using a clinically validated tropism test to determine whether a patient should be treated with a CCR5 inhibitor," said Monogram Biosciences CEO William Young. "Our Trofile assay is the only test currently available that can provide accurate, reproducible results to guide treatment with this new class of medications." Monogram's Trofile(TM) assay was used to select patients for participation in the pivotal clinical trials that formed the basis of approval for Selzentry and is being used in every advanced CCR5 inhibitor development program currently underway. In addition to calling for tropism testing to select patients for CCR5 inhibitor therapy, the new DHHS guidelines acknowledge the potential benefits of testing following CCR5 inhibitor treatment failure, which would determine whether or not the patient's HIV experienced a shift in viral tropism while on the therapy. The DHHS guidelines recommend only high- throughput phenotypic assays be used for co-receptor testing for CCR5 therapeutics at this time and acknowledge that genotypic assays, while under investigation, are currently not commercially available. About Trofile Trofile is a patient selection co-receptor tropism assay that determines whether a patient is infected with a strain of HIV that uses either the CCR5 coreceptor, the CXCR4 coreceptor, or a combination of CCR5 and CXCR4 to enter cells. The use of CCR5, CXCR4 or both coreceptors defines the "tropism" of the virus strain. Trofile amplifies the envelope gene from a patient's HIV genome (from their blood sample) and then uses it to make HIV particles containing the patient's virus envelope protein. The resultant HIV particles are then used to infect cells that contain the CCR5 co-receptor or the CXCR4 co- receptor on the cell surface. Once the virus infects the cell, it undergoes a single round of replication. Virus replication results in the production of luciferase from a luciferase gene that is carried into the cell by the virus. The production of luciferase in either CCR5 cells, CXCR4 cells or both cell types defines the co-receptor tropism of the patient virus. Trofile is the only clinically validated tropism assay and has been used to select patients in all phase II and phase III studies of CCR5 antagonists to date.
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