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Monogram Biosciences Announces Immediate Availability of Enhanced Sensitivity Trofile(TM) HIV Tropism Assay
Date:6/5/2008

ion, such as the enhanced sensitivity of Trofile, which will give physicians important information when deciding whether or not to incorporate a CCR5 antagonist like Selzentry into a patient's treatment regimen," said Dr. Howard Mayer, MD, Executive Director, Pfizer Development Team Leader for HIV/AIDS. Pfizer and Monogram have a collaboration agreement for commercialization of Trofile outside of the U.S.

"Detection of CXCR4-using minority variants has been shown as an important indicator of CCR5 antagonist treatment success and Trofile is the only clinically validated assay to identify co-receptor tropism, a step the FDA and EMEA has determined is critical in selecting patients for treatment with a CCR5 antagonist," said Monogram CEO William Young. "Trofile is the gold standard in tropism testing and the enhanced sensitivity version now available sets a new standard for performance so that the thousands of physicians who rely on our assay can better direct patient selection."

Trofile examines the complete gp160 coding region of the HIV-1 envelope protein, ensuring that all of the determinants of tropism are tested. In a retrospective analysis reported at the recent Conference on Retroviruses and Opportunistic Infections, the enhanced assay improved patient selection by identifying more cases of dual / mixed virus, and more accurately predicted virologic outcomes. In addition to providing patient selection for Selzentry's pivotal trials, Trofile has been used for patient selection and monitoring in all Phase II and III clinical trials of co-receptor antagonists.

About Trofile

Trofile is a clinically validated patient selection tropism assay that determines whether a patient is infected with a strain of HIV that uses either the CCR5 co-receptor, the CXCR4 co-receptor, or a combination of CCR5 and CXCR4 to enter cells. The use of CCR5, CXCR4 or both co-receptors defines the "tropism" of the virus strain. Trofile amplifies the envelope gene
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SOURCE Monogram Biosciences, Inc.
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