Monogram Obtains Coverage for Trofile(TM) Assay from California ADAP Program
2007年11月7日 - 9:00PM
PRニュース・ワイアー (英語)
Reimbursement Progress for the Only Clinically Validated Tropism
Assay SOUTH SAN FRANCISCO, Calif., Nov. 7 /PRNewswire-FirstCall/ --
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
http://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. 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 of Feinstein Kean Healthcare, +1-415-677-2700, , for
Monogram Biosciences, Inc. Web site: http://www.monogrambio.com/
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