All California public payers now cover Monogram's Trofile assay
SOUTH SAN FRANCISCO, Calif., March 17 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM) today announced that the California Medicaid program (Medi-Cal) has established coverage and reimbursement for Monogram's Trofile Assay.
Medi-Cal is the state medical assistance program in California established to provide essential medical care and services to individuals or families on public assistance, or whose income is not sufficient to meet their individual needs.
"We are delighted that Medi-Cal has established coverage for Trofile," said Bill Welch, Monogram chief commercial officer. "California has the second largest population of HIV/AIDS patients in the U.S. and now all public payers in the state provide coverage for Trofile. With coverage now clarified, we expect that testing activity for Medi-Cal beneficiaries may increase."
Previously, the California ADAP Program (in November 2007), and the federal Medicare Program (in September 2007) established coverage for Trofile. The AIDS Drug Assistance Program, or "ADAP", is a state and federally funded program, administered separately in each state to provide healthcare coverage for HIV/AIDS patients without other coverage. Throughout the U.S. 33 state ADAP/Ryan White entitlement state programs now have coverage established for Trofile.
Trofile is now a covered benefit with 24 state Medicaid programs, including California, Florida, Illinois, Maryland, Massachusetts, Michigan, New Jersey, Ohio, Texas and Wisconsin. In addition, Trofile is a covered benefit by Medicare, the Veteran's Administration, the Corrections and Prison Systems and Department of Indian Affairs, as well as with a number of private payers.
Monogram introduced Trofile in August 2007, upon FDA approval of Pfizer's Selzentry(TM) (maraviroc), and since then, almost 5,000 tests have been performed for patients throughout the U.S. In January 2008 DHHS Guidelines for Use of Antiretroviral Agents in HIV - 1 infected Adults & Adolescents recommend the use of the Trofile assay whenever the use of a CCR5 inhibitor is being considered as well as to be considered for patients who exhibit virologic failure on a CCR5 inhibition.
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 anti-viral 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 are forward-looking. These forward-looking statements include references to the demand for our Trofile Assay, the potential use of our Trofile Assay for patient selection for maraviroc, the size and timing of clinical trials utilizing our products, the outlook for maraviroc and our Trofile Assay, the number of patients each year in the U.S. who potentially could be candidates for new classes of HIV drugs such as maraviroc, expected protection provided by patents, possible regulation of Trofile and our other products by the FDA, and activities expected to occur in connection with the Pfizer collaboration. 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 physicians may not use a molecular diagnostic for patient selection for maraviroc or other HIV drugs; risks related to the implementation of the collaboration with Pfizer; risks related to our ability to recognize revenue from activities under 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, entry inhibitors or integrase inhibitors; the risk that our Trofile Assay may not be utilized for patient use with maraviroc and other 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 payers will authorize reimbursement for our products and services and the amount of such reimbursement that may be allowed; whether the FDA or any other agency will decide to further regulate our products or services, including Trofile; whether the draft guidance on Multivariate Index Assays issued by FDA will be subsequently determined to apply to our current or planned products; 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; restrictions on the conduct of our business imposed by the Pfizer, Merrill Lynch and other debt agreements; the impact of additional dilution if our convertible debt is converted to equity; and whether we will be able to raise sufficient capital in the future, if required. For a discussion of other factors that may cause 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.
Contacts: Alfred G. Merriweather Jeremiah Hall
Chief Financial Officer Feinstein Kean Healthcare
Tel: 650 624 4576 Tel: 415 677 2700
|SOURCE Monogram Biosciences, Inc.|
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