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DHHS Guidelines Support Use of Trofile(TM) Assay Prior to CCR5 Inhibitor Use
Date:2/4/2008

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.

About Monogram

Monogram is a biotechnology company advancing individualized medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious infectious diseases and cancer. The Company's products are designed to help doctors optimize t
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SOURCE Monogram Biosciences, Inc.
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