Published:
Medical Policy Guideline for Trofile(TM) Established By Wellpoint, Inc.
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 andWisconsin. 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.
About Monogram
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
amerriweather@fkhealth.com
Jeremiah Hall
Feinstein Kean Healthcare
Tel: 415 677-2700
jeremiah.hall@monogrambio.com
SOURCE Monogram Biosciences, Inc.
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