Healthcare Industry News: Trofile Assay
News Release - August 6, 2007
Monogram Announces Commercial Introduction of Trofile(TM) AssayAdvanced diagnostic supports appropriate use of Pfizer's newly FDA-approved CCR5 antagonist, Selzentry(TM)(maraviroc) tablets
SOUTH SAN FRANCISCO, Calif., Aug. 6 (HSMN NewsFeed) -- Monogram Biosciences, Inc. (Nasdaq: MGRM ) today announced the launch of the company's latest HIV diagnostic, the Trofile(TM) co-receptor tropism assay. This launch follows the announcement that Pfizer Inc (NYSE: PFE ) has received FDA approval today of novel HIV therapy, Selzentry(TM) (maraviroc) tablets. Trofile was the pivotal test used for patient selection for Selzentry's clinical development program and the two companies are engaged in a collaboration agreement to make Monogram's assay available for patient use globally.
Selzentry has been approved for the combination antiretroviral treatment of adults infected with only CCR5-tropic HIV-1 who have evidence of viral replication and have HIV-1 strains resistant to multiple antiretroviral agents. In a first for an HIV drug approval, the FDA approved label requires that tropism testing to identify patients infected with R5 virus guide the use of Selzentry. Trofile is the only clinically proven diagnostic that can be used to determine viral tropism.
"The availability of Selzentry and Trofile come at a time when increasing drug resistance makes treating HIV more complex than ever," said Douglas Richman, M.D., Professor of Pathology and Medicine at the University of California, San Diego School of Medicine, and the Director of the Research Center for AIDS and HIV Infection at the San Diego VA Medical Center. "Monogram's Trofile Assay is a highly sensitive and precise diagnostic that will play a critically important role in bringing a new therapeutic approach to physicians and patients running low on options. Trofile, like Monogram's resistance tests, will become an integral part of the treatment landscape for HIV patients."
Trofile Assays have been performed on more than 23,000 samples in the company's CLIA-certified laboratory. Trofile results are summarized in an easy-to-understand report indicating the patient's HIV tropism and are delivered to physicians in approximately 14 days. "We have already introduced the Trofile Assay and its clinical value to physicians in Selzentry's expanded access program (EAP) and to many of the larger public and private payers," said William Welch, Monogram's chief commercial officer. "Our initial feedback from payers indicates that, like physicians, they will appreciate the benefits of Trofile in identifying HIV patients who are most likely to respond to CCR5 therapy."
Monogram has provided its assays to HIV clinicians for several years through a well established commercial infrastructure throughout the United States. Monogram will continue working with HIV physicians, patients and patient advocates, public and private payers, to provide broad access and to establish specific payer coverage and reimbursement for Trofile in the U.S. market. Monogram is making Trofile available to physicians immediately, so that it can be used to select patients in advance of Pfizer making Selzentry available in pharmacies.
Conference Call Details
Monogram will host a conference call to discuss plans for commercial introduction of Trofile in the U.S. The call will take place on Tuesday, August 7 and details of the call will be announced as soon as possible.
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 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.
Source: Monogram Biosciences
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