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
amerriweather@fkhealth.com
Jeremiah Hall
Feinstein Kean Healthcare
Tel: 415 677-2700
jeremiah.hall@monogrambio.com
SOURCE Monogram Biosciences, Inc.
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Related links:
http://www.monogrambio.com
CONTACT:
Alfred G. Merriweather, Chief Financial
Officer of Monogram Biosciences, Inc., +1-650-624-4576,
amerriweather@fkhealth.com; Jeremiah Hall, Feinstein Kean
Healthcare, +1-415-677-2700, jeremiah.hall@monogrambio.com
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