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."
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
|SOURCE Monogram Biosciences, Inc.|
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