Medicare to Pay for Trofile at Monogram's List Price
SOUTH SAN FRANCISCO, Calif., Sept. 24 /PRNewswire-FirstCall/ --
Monogram Biosciences, Inc. (Nasdaq: MGRM) today announced that the first
Medicare payment for its Trofile Assay has been processed, at an amount
equal to Monogram's list price, by the National Heritage Insurance Company
(NHIC), the contractor that administers Medicare programs in California.
NHIC had previously established coding guidance for Trofile. For
patients throughout the U.S., Medicare claims for Trofile are submitted to
NHIC, which is the local Medicare part B Contractor in California, where
Trofile tests are performed. NHIC's coding guidance for healthcare
providers references the need for tropism testing as indicated in the FDA
labeling for maraviroc, and acknowledges that Monogram's Trofile Assay was
the test for tropism on which the FDA clinical trials of Selzentry
(maraviroc) were based.
Monogram's Trofile Assay is the only clinically validated assay for
assessing tropism of patients, is the only assay that has been used in
phase II and phase III clinical trials of CCR5 antagonists, and has been
used in all such clinical trials to date.
"Providing this reimbursement for Trofile is an important
acknowledgement by Medicare of the value of Trofile as a tool for guiding
the use of Selzentry," said William D. Young, Monogram CEO. "We are making
good progress in our discussions with other public and private payers with
regard to reimbursement for Trofile and, to date, we have submitted claims
to 15 separate payers. We are encouraged by the initial adoption of Trofile
by physicians."
About Trofile
Trofile is a patient selection co-receptor tropism assay that
determines whether a patient is infected with a strain of HIV that uses
either the CCR5 coreceptor, the CXCR4 coreceptor, or a combination of CCR5
and CXCR4 to enter cells. The use of CCR5, CXCR4 or both coreceptors
defines the "tropism" of the virus strain. Trofile amplifies the envelope
gene from a patient's HIV genome (from their blood sample) and then uses it
to make HIV particles containing the patient's virus envelope protein. The
resultant HIV particles are then used to infect cells that contain the CCR5
co-receptor or the CXCR4 co- receptor on the cell surface. Once the virus
infects the cell and it undergoes a single round of replication. Virus
replication results in the production of luciferase from a luciferase gene
that is carried into the cell by the virus The production of luciferase in
either CCR5 cells, CXCR4 cells or both cell types defines the co-receptor
tropism of the patient virus.
About Monogram Biosciences, Inc.
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 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 potential for an HIV
drug that requires a molecular diagnostic for patient selection. 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:
risks related to the market acceptance of Selzentry and ongoing and future
clinical trials of Selzentry; whether competitive tropism assays are
developed and commercialized by others; whether third party payers will
provide coverage and reimbursement for the Trofile Assay; the level of
reimbursement that third party payers will authorize for Trofile; risks
related to the implementation of 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 or entry inhibitors; the use of our Trofile Assay for
patient use with Selzentry; 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; whether payors will authorize reimbursement for our products
and services; whether the FDA or any other agency will decide to further
regulate our products or services; 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; and whether we will be able to raise sufficient capital in the
future, if required. For a discussion of other factors that may cause our
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 Jeremiah Hall
Chief Financial Officer Feinstein Kean Healthcare
Tel: 650 624-4576 Tel: 415 677-2700
amerriweather@monogrambio.com jeremiah.hall@fkhealth.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@monogrambio.com; or Jeremiah Hall of Feinstein Kean
Healthcare, +1-415-677-2700, jeremiah.hall@fkhealth.com, for
Monogram Biosciences, Inc.
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