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NHIC had previously established coding guidance for Trofile. For patientsthroughout the U.S., Medicare claims for Trofile are submitted to NHIC, whichis the local Medicare part B Contractor in California, where Trofile tests areperformed. NHIC's coding guidance for healthcare providers references theneed for tropism testing as indicated in the FDA labeling for maraviroc, andacknowledges that Monogram's Trofile Assay was the test for tropism on whichthe FDA clinical trials of Selzentry (maraviroc) were based.
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Monogram's Trofile Assay is the only clinically validated assay forassessing tropism of patients, is the only assay that has been used in phaseII and phase III clinical trials of CCR5 antagonists, and has been used in allsuch clinical trials to date.
"Providing this reimbursement for Trofile is an important acknowledgementby Medicare of the value of Trofile as a tool for guiding the use ofSelzentry," said William D. Young, Monogram CEO. "We are making good progressin our discussions with other public and private payers with regard toreimbursement for Trofile and, to date, we have submitted claims to 15separate payers. We are encouraged by the initial adoption of Trofile byphysicians."
About Trofile
Trofile is a patient selection co-receptor tropism assay that determineswhether a patient is infected with a strain of HIV that uses either the CCR5coreceptor, the CXCR4 coreceptor, or a combination of CCR5 and CXCR4 to entercells. The use of CCR5, CXCR4 or both coreceptors defines the "tropism" of thevirus strain. Trofile amplifies the envelope gene from a patient's HIV genome(from their blood sample) and then uses it to make HIV particles containingthe patient's virus envelope protein. The resultant HIV particles are thenused to infect cells that contain the CCR5 co-receptor or the CXCR4 co-receptor on the cell surface. Once the virus infects the cell and it undergoesa single round of replication. Virus replication results in the production ofluciferase from a luciferase gene that is carried into the cell by the virusThe production of luciferase in either CCR5 cells, CXCR4 cells or both celltypes defines the co-receptor tropism of the patient virus.
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 technology can be found on its web siteat www.monogrambio.com.
Forward Looking Statements
Certain statements in this press release are forward-looking. Theseforward-looking statements include references to the potential for an HIV drugthat 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 anticipatedresults or other expectations expressed in such forward-looking statements.These risks and uncertainties include, but are not limited to: risks relatedto the market acceptance of Selzentry and ongoing and future clinical trialsof Selzentry; whether competitive tropism assays are developed andcomme
