Medicare Contractor Establishes Reimbursement Coding Guidance for Monogram's Trofile Assay
September 05 2007 - 7:00AM
PR Newswire (US)
Healthcare providers receive guidance for coding of claims to
Medicare for Trofile(TM) as tropism test for Pfizer's Selzentry(TM)
SOUTH SAN FRANCISCO, Calif., Sept. 5 /PRNewswire-FirstCall/ --
Monogram Biosciences, Inc. (NASDAQ:MGRM) today announced that the
National Heritage Insurance Company (NHIC), the contractor that
administers Medicare programs in California, has established coding
procedures for the company's Trofile Assay. 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. The coding guidance for healthcare
providers is reported in the Medicare Coverage Database in an
article entitled "Trofile Test for Maraviroc Therapy". The article
is available on the Centers for Medicare and Medicaid Services
(CMS) website at
http://www.cms.hhs.gov/mcd/viewarticle.asp?article_id=45784&article_version=2&
show=all (Due to length of URL, please cut and paste into browser).
The article 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. "Recognition by the CMS
Contractor of the need to reimburse for Trofile, as part of the use
of Selzentry, is a strong validation of the clinical utility of our
Trofile Assay," said William D. Young, Monogram CEO. "That it
should happen so quickly after FDA approval of Selzentry is very
encouraging." About Trofile Trofile is a patient selection
co-receptor tropism assay that determines which co-receptor a
patient's HIV strain or strains use for viral entry- CCR5, CXCR4,
or a combination of CCR5 and CXCR4. Which of these "cellular
gateways" that a particular HIV strain uses to gain entry into a
healthy CD4+ cell is known as the patients "tropism". Trofile
amplifies a patient's HIV genome (from their blood sample) to make
HIV particles specific to that individual patient. The resultant
HIV particles are then used to infect CCR5- and CXCR4- expressing
cell lines. Once the virus infects the cell and undergoes its
single round of replication, a reporter gene expresses its
indicator gene (luciferase), giving a visible signal-thus
identifying the patient's viral tropism. Viral load must be at
least 1000 copies/mL to determine a patient's viral tropism. 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; 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@ jeremiah.hall@ monogrambio.com
fkhealth.com DATASOURCE: Monogram Biosciences, Inc. CONTACT: Alfred
G. Merriweather, Chief Financial Officer of Monogram Biosciences,
Inc., +1-650-624-4576, ; or Jeremiah Hall of Feinstein Kean
Healthcare for Monogram Biosciences, Inc., +1-415-677-2700, Web
site: http://www.monogrambio.com/
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