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Monogram Provides Update on Trofile(TM) Co-Receptor Tropism Assay

Wednesday, September 19, 2007 General News
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SOUTH SAN FRANCISCO, Calif., Sept. 18 MonogramBiosciences, Inc. (Nasdaq: MGRM) announced today that its collaborator Pfizer,Inc. (NYSE: PFE) has separately announced data that reinforces long-termsafety and efficacy of Pfizer's oral CCR5-antagonist, Selzentry (Maraviroc),which was recently approved by the FDA and is now available throughout theU.S. Monogram's co-receptor tropism assay, Trofile(TM), was used for patientselection for Selzentry's clinical development program, and is currently beingmarketed by Monogram's 50-strong sales and marketing organization. Recently,Monogram announced that the contractor that administers Medicare programs inCalifornia has established coding procedures for the company's Trofile Assay,indicating Medicare coverage of Trofile throughout the U.S.
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At the Interscience Conference on Antimicrobial Agents and Chemotherapy(ICAAC) meeting in Chicago, Pfizer presented data from a planned 48-weekanalysis of its clinical studies of Selzentry in treatment-experiencedpatients. This analysis confirms the previous 24-week data on which the FDAapproval of Selzentry was based. The 48-week analysis showed:
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Monogram's phenotypic resistance tests were used to optimize backgroundtherapy in Selzentry's clinical trials.

Selzentry is designed to work differently from other available HIVmedications. CCR5 antagonists block the virus from gaining access intohealthy cells via the CCR5 co-receptor, a common pathway for viral entry.Monogram's Trofile co-receptor tropism assay identifies whether individualstrains of HIV use the CCR5 co-receptor, the CXCR4 co-receptor or both co-receptors to infect healthy cells. This helps clinicians determine whether aCCR5 antagonist like maraviroc may be a good therapeutic option for treatingindividual patients. Currently available in the U.S., Selzentry is the firstdrug in a new oral class of HIV medications to be approved in more than tenyears. Selzentry (Maraviroc) is under review with European regulatoryauthorities and recently received a positive opinion from the CHMP.

Selzentry and other entry inhibitors currently in development come at atime when increasing drug resistance makes treating HIV more difficult thanever. Highly sensitive and precise diagnostic tools, such as Trofile, areplaying an ever more important role in the development of new therapeuticapproaches that give new hope to physicians and patients running low onoptions.

About Trofile

Trofile is a patient selection co-receptor tropism assay that determineswhich co-receptor a patient's HIV strain or strains use for viral entry- CCR5,CXCR4, or a combination of CCR5 and CXCR4. Which of these "cellular gateways"that a particular HIV strain uses to gain entry into a healthy CD4+ cell isknown as the patients "tropism." Trofile amplifies a patient's HIV genome(from their blood sample) to make HIV particles specific to that individualpatient. The resultant HIV particles are then used to infect CCR5- and CXCR4-expressing cell lines. Once the virus infects the cell and undergoes itssingle round of replication, a reporter gene expresses its indicator gene(luciferase), giving a visible signal-thus identifying the patient's viraltropism. Viral load must be at least 1000 copies/mL to determine a patient'sviral tropism.

About Monogram Biosciences, Inc.

Monogram is advancing individualized medicine by discovering, developingand marketing innovative products to guide and improve treatment of seriousinfectious diseases and cancer. The Company's products are designed to helpdoctors optimize treatment regimens for their patients that lead to betteroutcomes and reduced costs. The Company's technology is also being used bynumerous biopharmaceutical companies to develop new and improved antiviraltherapeutics and vaccines as well as targeted cancer therapeutics. Moreinformation about the Company and its technolog
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