Medical Policy Guideline for Trofile(TM) Established By Wellpoint, Inc.
August 20 2008 - 9:00AM
PR Newswire (US)
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. 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 Jeremiah Hall Feinstein Kean
Healthcare Tel: 415 677-2700 DATASOURCE: Monogram Biosciences, Inc.
CONTACT: Alfred G. Merriweather, Chief Financial Officer of
Monogram Biosciences, Inc., +1-650-624-4576, ; Jeremiah Hall,
Feinstein Kean Healthcare, +1-415-677-2700, Web site:
http://www.monogrambio.com/
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