MGRM Monogram Technologies Inc

Committee discusses use of Monogram's Trofile Assay for patient selection SOUTH SAN FRANCISCO, Calif., April 24 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (NASDAQ:MGRM) announced today that the U.S. Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee has voted unanimously to recommend that collaborator Pfizer, Inc.'s (NYSE:PFE) investigational HIV medication, maraviroc, be approved for use along with other antiretroviral agents for treatment-experienced adult patients infected with CCR5-tropic HIV-1. Although not bound by the Advisory Committee's recommendations, the FDA usually follows them. If approved, maraviroc would be the first member of a new class of oral HIV medicines in more than a decade. Monogram's Trofile(TM) Assay has been used to select patients for the clinical trials of maraviroc. Information provided by Pfizer to the advisory panel indicates that "the results in treatment-experienced patients with CCR5-tropic versus non CCR5- tropic HIV-1 provide clinical data validating Monogram's Trofile Assay as an effective and appropriate means to identify patients with CCR5-tropic HIV-1 and who are therefore likely to respond to maraviroc." Over 23,000 Trofile Assays have been performed since 2004 in Monogram's CLIA certified laboratory. Trofile is the only diagnostic proven in clinical studies to identify whether patients are CCR5-tropic and has been used in all clinical trials of CCR5 antagonists to date. In addition, Monogram performs tens of thousands of phenotypic and genotypic resistance tests annually, including the PhenoSenseGT(TM) assay that was used to optimize background therapy in the clinical trials of maraviroc. "We are ready to make our Trofile Assay available commercially as soon as maraviroc is approved," said Monogram CEO William Young. "We intend to bring Trofile to the HIV physician community through our existing sales, marketing and distribution channels throughout the U.S." Additional studies are underway to determine maraviroc's effectiveness in treatment-naive patients. Turnaround time for the Trofile Assay is currently approximately two weeks. About Monogram Biosciences, Inc. Monogram is 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 treatment regimens for their patients that lead to better outcomes and reduced costs. The Company's technology is also being used by numerous biopharmaceutical companies to develop new and improved antiviral therapeutics and vaccines as well as targeted cancer therapeutics. More information about the Company and its technology can be found on its web site at http://www.monogrambio.com/ . Forward Looking Statements Certain statements in this press release and attached supplemental information are forward-looking. These forward-looking statements include references to the potential for an HIV drug that requires a molecular diagnostic for patient selection. These forward-looking statements are subject to risks and uncertainties and other factors, which may cause actual results to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that regulatory authorities may not require or recommend a molecular diagnostic for patient selection for an HIV drug, risks related to the implementation of the collaboration with Pfizer; risks and uncertainties relating to the performance of our products; the growth in revenues; the size, timing and success or failure of any clinical trials for CCR5 inhibitors or entry inhibitors; the use of our Co-Receptor Tropism Assay for patient use in the event of approval of any CCR5 inhibitors; our ability to successfully conduct clinical studies and the results obtained from those studies; whether larger confirmatory clinical studies will confirm the results of initial studies; our ability to establish reliable, high-volume operations at commercially reasonable costs; expected reliance on a few customers for the majority of our revenues; the annual renewal of certain customer agreements; actual market acceptance of our products and adoption of our technological approach and products by pharmaceutical and biotechnology companies; our estimate of the size of our markets; our estimates of the levels of demand for our products; the impact of competition; the timing and ultimate size of pharmaceutical company clinical trials; whether payors will authorize coverage and reimbursement for our products and services; whether the FDA or any other agency will decide to further regulate our any of our products or services, including Trofile; whether we will encounter problems or delays in automating our processes; the ultimate validity and enforceability of our patent applications and patents; the possible infringement of the intellectual property of others; whether licenses to third party technology will be available; whether we are able to build brand loyalty and expand revenues; and whether we will be able to raise sufficient capital in the future, if required. For a discussion of other factors that may cause our actual events to differ from those projected, please refer to our most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other subsequent filings with the Securities and Exchange Commission. We do not undertake, and specifically disclaim any obligation, to revise any forward-looking statements to reflect the occurrence of anticipated or unanticipated events or circumstances after the date of such statements. Trofile and PhenoSenseGT are trademarks of Monogram Biosciences, Inc. Contacts: Alfred G. Merriweather Jeremiah Hall Chief Financial Officer Feinstein Kean Healthcare Tel: 650 624-4576 Tel: 415 677-2700 DATASOURCE: Monogram Biosciences, Inc. CONTACT: Alfred G. Merriweather, Chief Financial Officer, of Monogram Biosciences, Inc., +1-650-624-4576, ; or Jeremiah Hall of Feinstein Kean Healthcare, for Monogram Biosciences, Inc., +1-415-677-2700, Web site: http://www.monogrambio.com/

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