Healthcare Industry News:  integrase inhibitor 

Diagnostics Reimbursement HIV/AIDS

 News Release - November 7, 2007

Monogram Obtains Coverage for Trofile(TM) Assay from California ADAP Program

Reimbursement Progress for the Only Clinically Validated Tropism Assay

SOUTH SAN FRANCISCO, Calif., Nov. 7 (HSMN NewsFeed) -- Monogram Biosciences, Inc. (Nasdaq: MGRM ) today announced that the California ADAP program under the California Office of AIDS has established coverage and reimbursement for Monogram's Trofile Assay. This coverage will be administered by the "Public Health Service Bureau", the California ADAP Program's Pharmacy Benefit Manager. The California Office of AIDS has the lead responsibility for coordinating state programs, services and activities relating to HIV/AIDS for the State of California. 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.

Monogram introduced Trofile in August 2007, upon FDA approval of Pfizer's Selzentry(TM) (maraviroc), and since then, approximately 2,000 tests have been requested. Approximately 1,200 tests have been performed, of which approximately 400 have been for clients and payers for whom reimbursement arrangements are in place, and for which revenue is recorded. "We are pleased with this initial acceptance of Trofile," said William Young, Monogram chief executive officer. "We believe that the message from both Pfizer and Monogram that Trofile is the only clinically validated method of assessing tropism is being well received by physicians." Monogram and Pfizer Inc have a collaboration to make Trofile available globally.

"We are pleased with this acknowledgement from the California ADAP program of the value of Trofile," continued Young. "ADAP programs provide a valuable safety net for patients with no other insurance coverage. We are working with state Medicaid programs as well as private insurance plans to add coverage for Trofile to those programs." Coverage by Medicare was established in September 2007. Monogram is an approved vendor to the Federal Supply Schedule and in September we gained coverage for Trofile to service the U.S. Departments of Veterans Affairs and Indian Affairs and the Federal Bureau of Prisons.

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 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 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.


Source: Monogram Biosciences

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