SOUTH SAN FRANCISCO, Calif., Sept. 5 MonogramBiosciences, Inc. (Nasdaq: MGRM) today announced that the National HeritageInsurance Company (NHIC), the contractor that administers Medicare programs inCalifornia, has established coding procedures for the company's Trofile Assay.For patients throughout the U.S., Medicare claims for Trofile are submitted toNHIC, which is the local Medicare part B Contractor in California, whereTrofile tests are performed.
The coding guidance for healthcare providers is reported in the MedicareCoverage Database in an article entitled "Trofile Test for Maraviroc Therapy".The article is available on the Centers for Medicare and Medicaid Services(CMS) website athttp://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). Thearticle references the need for tropism testing as indicated in the FDAlabeling for maraviroc, and acknowledges that Monogram's Trofile Assay was thetest 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 clinicalutility of our Trofile Assay," said William D. Young, Monogram CEO. "That itshould happen so quickly after FDA approval of Selzentry is very encouraging."
Trofile is a patient selection co-receptor tropism assay that determineswhich 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 isknown as the patients "tropism". Trofile amplifies a patient's HIV genome(from their blood sample) to make HIV particles specific to that individualpatient. The resultant HIV particles are then used to infect CCR5- and CXCR4-expressing cell lines. Once the virus infects the cell and undergoes itssingle round of replication, a reporter gene expresses its indicator gene(luciferase), giving a visible signal-thus identifying the patient's viraltropism. Viral load must be at least 1000 copies/mL to determine a patient'sviral tropism.
About Monogram Biosciences, Inc.
Monogram is advancing individualized medicine by discovering, developingand marketing innovative products to guide and improve treatment of seriousinfectious diseases and cancer. The Company's products are designed to helpdoctors optimize treatment regimens for their patients that lead to betteroutcomes and reduced costs. The Company's technology is also being used bynumerous biopharmaceutical companies to develop new and improved antiviraltherapeutics and vaccines as well as targeted cancer therapeutics. Moreinformation about the Company and its technology can be found on its web siteat http://www.monogrambio.com.
Forward Looking Statements
Certain statements in this press release are forward-looking. Theseforward-looking statements include references to the potential for an HIV drugthat 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 anticipatedresults or other expectations expressed in such forward-looking statements.These risks and uncertainties include, but are not limited to: risks relatedto the market acceptance of Selzentry and ongoing and future clinical trialsof Selzentry; whether competitive tropism assays are developed andcommercialized by others; whether third party payers will provide coverage andreimbursement for the Trofile Assay; risks related to the implementation ofthe collaboration with Pfizer; risks and uncertainties relating to theperformance of our products; the growth in revenues; the size, timing andsu