| |
Monogram Biosciences (MGRM) Lauches Trofile Co-Receptor Tropism Assay
|
| |
| |
08-06-2007 01:26:03 PM
Monogram Biosciences, Inc. (Nasdaq: MGRM) announced the launch of the company's latest HIV diagnostic, the Trofile co-receptor tropism assay. This launch follows the announcement that Pfizer Inc (NYSE: PFE) has received FDA approval today of novel HIV therapy, Selzentry tablets. Trofile was the pivotal test used for patient selection for Selzentry's clinical development program and the two companies are engaged in a collaboration agreement to make Monogram's assay available for patient use globally.
"Trofile is a vital new tool that helps physicians make the most informed treatment decisions for their patients living with HIV. Combined with Pfizer's new therapy, this represents a major milestone in the treatment of HIV," said Monogram CEO Bill Young. "Today's approval also marks an important landmark in personalized medicine as the healthcare community shifts to treat patients individually by combining powerful diagnostic tools with drug therapies to better predict an individual patient's response."
Selzentry has been approved for the combination antiretroviral treatment of adults infected with only CCR5-tropic HIV-1 who have evidence of viral replication and have HIV-1 strains resistant to multiple antiretroviral agents. In a first for an HIV drug approval, the FDA approved label requires that tropism testing to identify patients infected with R5 virus guide the use of Selzentry. Trofile is the only clinically proven diagnostic that can be used to determine viral tropism.
|
|
| |
| |
|
|
|
