Licensee of Blue Cross/Blue Shield in fourteen states establishes
guidelines for use of Trofile
SOUTH SAN FRANCISCO, Calif., Aug. 20 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM) today announced that Wellpoint, Inc. has established a national Medical Policy Guideline for Monogram's Trofile Assay.
Wellpoint's guidelines provide that HIV tropism testing with Trofile is considered medically necessary for selecting individuals for treatment with CCR5 antagonists (i.e. Selzentry(TM)) for patients who have experienced virologic failure during antiretroviral treatment regimens and who have evidence of ongoing HIV-1 viral replication. Further, these guidelines confirm that Trofile is the only assay approved by Wellpoint for determining coreceptor tropism. Wellpoint has developed medical policies and guidelines that serve as some of the guidelines for coverage decisions by individual plans.
"Through its Blue Cross and Blue Shield plans, Wellpoint is one of the largest private healthcare payers in the U.S. and covers almost 35 million lives throughout its networks," said William Welch, Monogram's chief commercial officer. "Many of the individual Blue Cross and Blue Shield plans have been providing coverage for Trofile and we are pleased to see this guideline established at the national level."
Wellpoint, Inc. (formerly Anthem, Inc.) is an independent licensee of the Blue Cross and Blue Shield Association, an association of independent health benefit plans and serves as the Blue Cross and/or Blue Shield licensee in: California, Colorado, Connecticut, Georgia, Indiana, Kentucky, Maine, Missouri, Nevada, New Hampshire, New York, Ohio, Virginia and Wisconsin. Many of these individual Blue Cross and Blue Shield plans establish coverage policies for their members and the parent company also establishes national coverage policies that can be referenced by the individual plans.
Monogram is a biotechnology company 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 http://www.monogrambio.com.
Forward Looking Statements
Certain statements in this press release are forward-looking. These forward-looking statements include references to the use of our resistance assays, including PhenoSense Integrase, and our Trofile Assay, the size and timing of clinical trials utilizing our products. 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 or monitoring for Isentress, Selzentry or other HIV drugs; 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; 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.
PhenoSense and PhenoSense GT are registered trademarks and Trofile is a
trademark of Monogram Biosciences, Inc. Isentress is a trademark of Merck &
Co., Inc. and Selzentry is a trademark of Pfizer Inc.
contacts: Alfred G. Merriweather
Chief Financial Officer
Tel: 650 624-4576
Feinstein Kean Healthcare
Tel: 415 677-2700
|SOURCE Monogram Biosciences, Inc.|
Copyright©2008 PR Newswire.
All rights reserved