Monogram Announces First Medicare Payment for Trofile(TM)
Monday September 24, 7:00 am ET
Medicare to Pay for Trofile at Monogram's List Price
SOUTH SAN FRANCISCO, Calif., Sept. 24 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM - News) today announced that the first Medicare payment for its Trofile Assay has been processed, at an amount equal to Monogram's list price, by the National Heritage Insurance Company (NHIC), the contractor that administers Medicare programs in California.
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NHIC had previously established coding guidance for Trofile. For patients throughout the U.S., Medicare claims for Trofile are submitted to NHIC, which is the local Medicare part B Contractor in California, where Trofile tests are performed. NHIC's coding guidance for healthcare providers references the need for tropism testing as indicated in the FDA labeling for maraviroc, and acknowledges that Monogram's Trofile Assay was the test for tropism on which the FDA clinical trials of Selzentry (maraviroc) were based.
Monogram's Trofile Assay is the only clinically validated assay for assessing tropism of patients, is the only assay that has been used in phase II and phase III clinical trials of CCR5 antagonists, and has been used in all such clinical trials to date.
"Providing this reimbursement for Trofile is an important acknowledgement by Medicare of the value of Trofile as a tool for guiding the use of Selzentry," said William D. Young, Monogram CEO. "We are making good progress in our discussions with other public and private payers with regard to reimbursement for Trofile and, to date, we have submitted claims to 15 separate payers. We are encouraged by the initial adoption of Trofile by physicians."
About Trofile
Trofile is a patient selection co-receptor tropism assay that determines whether a patient is infected with a strain of HIV that uses either the CCR5 coreceptor, the CXCR4 coreceptor, or a combination of CCR5 and CXCR4 to enter cells. The use of CCR5, CXCR4 or both coreceptors defines the "tropism" of the virus strain. Trofile amplifies the envelope gene from a patient's HIV genome (from their blood sample) and then uses it to make HIV particles containing the patient's virus envelope protein. The resultant HIV particles are then used 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 undergoes a single round of replication. Virus replication results in the production of luciferase from a luciferase gene that is carried into the cell by the virus The production of luciferase in either CCR5 cells, CXCR4 cells or both cell types defines the co-receptor tropism of the patient virus.
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 www.monogrambio.com.
Forward Looking Statements
Certain statements in this press release 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: risks related to the market acceptance of Selzentry and ongoing and future clinical trials of Selzentry; whether competitive tropism assays are developed and commercialized by others; whether third party payers will provide coverage and reimbursement for the Trofile Assay; the level of reimbursement that third party payers will authorize for Trofile; 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 Trofile Assay for patient use with Selzentry; 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; whether payors will authorize reimbursement for our products and services; whether the FDA or any other agency will decide to further regulate our products or services; 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 is a trademark of Monogram Biosciences, Inc. Selzentry is a
trademark of Pfizer Inc.
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