Healthcare Industry News:  antiviral 

Diagnostics Biopharmaceuticals HIV/AIDS Reimbursement

 News Release - April 8, 2008

New York Medicaid Program Establishes Coverage for Trofile(TM)

Approximately 80% of U.S. HIV/AIDS Patients Live in States Now Providing Medicaid Coverage for Trofile

SOUTH SAN FRANCISCO, Calif., April 8, 2008 (HSMN NewsFeed) -- Monogram Biosciences, Inc. (Nasdaq: MGRM ) today announced that New York Medicaid has established coverage and reimbursement for Monogram's Trofile Assay, a diagnostic used to determine patient candidacy for Pfizer's new HIV anti-viral medication Selzentry(TM) (maraviroc).

Initiated in 1989 to ensure early identification and access to quality care for New Yorkers who can't afford medical care, the HIV Primary Care Medicaid Program revised its reimbursement structure in response to advances in HIV treatment and testing technology. With the establishment of coverage by the medicaid program, coverage will also be available from the New York ADAP program so that comprehensive coverage will now be available from all public payers in New York.

"New York remains the epicenter of the HIV/AIDS epidemic in the U.S.," said Dennis deLeon, President of the Latino Commission on AIDS. "The state's coverage and reimbursement of Trofile allows greater access to an advanced treatment option for the most vulnerable of our population living with HIV."

"We are very pleased that New York Medicaid has established coverage for Trofile," said Bill Welch, Monogram Chief Commercial Officer. "Now the medical public assistance programs for the states with the largest numbers of residents living HIV/AIDS -- namely California, Texas, Florida and New York -- recognize the need and provide reimbursement for accurate tropism testing."

Trofile is now a covered benefit among 25 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 6,000 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.

About Monogram

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 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 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.


Source: Monogram Biosciences

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