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Monogram Announces 2008 Third Quarter Financial Results
Date:10/27/2008

to the original assay. Monogram reassessed the original samples from the MERIT trial using the enhanced Trofile assay. These samples had been previously archived by Monogram and laboratory personnel had no knowledge of previous testing results or clinical outcomes data from the trial. The results obtained with the enhanced sensitivity version of the Trofile Assay were provided to Pfizer who conducted the clinical analysis in accordance with a prespecified statistical analysis plan.

Using the enhanced Trofile assay, 15% of MERIT screening samples previously defined as R5 HIV were reclassified as CXCR4-using (Dual/Mixed) HIV, and thus would have been unable to participate in the study. Analyses restricted to individuals with CCR5-tropic HIV as determined by the enhanced Trofile assay demonstrated an overall improvement in Selzentry efficacy relative to efavirenz (the control arm of the trial). In the new retrospective analysis of the MERIT trial samples, powered by the enhanced Trofile assay, 68% of individuals achieved HIV-1 RNA <50 copies/mL at week 48 in both the Selzentry and efavirenz arms of the study.

"Given the efficacy of existing first line treatments, achieving comparable results in this trial is a very positive result for Selzentry and demonstrates the value of Trofile in selecting patients," continued Young. "With this data, physicians can have increased confidence in their patient selection for Selzentry's current indication."

HERmark(TM) Breast Cancer Assay

"Our commercial introduction of HERmark is progressing well," continued Young. "Our oncology sales team is in place and initial HERmark tests have been performed for patients determined by existing technologies to be HER2-negative. As our prior clinical data suggests, these patients include some who have now been reclassified by HERmark as HER2 positive. Our commercial goals for HERmark in 2008 are to educate the breast cancer community on HERmark and to stimulate interest
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SOURCE Monogram Biosciences, Inc.
Copyright©2008 PR Newswire.
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