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SOUTH SAN FRANCISCO, Calif., Feb. 4 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM) today announced that guidelines issued by the Department of Health and Human Services (DHHS) recommend that a co-receptor tropism test, such as Monogram's Trofile(TM) assay, should be performed whenever the use of a CCR5 inhibitor is being considered and might also be considered for patients who exhibit virologic failure on a CCR5 inhibitor.
The Panel on Antiretroviral Guidelines for Adult and Adolescents guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents, Department of Health and Human Services, January 29, 2008, were developed by a working group of the Office of AIDS Research Advisory Counsel, the National Institutes of Health advisory body on HIV research and treatment policy and initiatives. These guidelines follow the FDA's instructions on Selzentry's label, which call for tropism testing prior to prescribing the drug. Pfizer's Selzentry(TM) (maraviroc) is the first CCR5 inhibitor to receive FDA approval.
"The Office of AIDS Research recommendations and DHHS guidelines underscore the importance of using a clinically validated tropism test to determine whether a patient should be treated with a CCR5 inhibitor," said Monogram Biosciences CEO William Young. "Our Trofile assay is the only test currently available that can provide accurate, reproducible results to guide treatment with this new class of medications."
Monogram's Trofile(TM) assay was used to select patients for
participation in the pivotal clinical trials that formed the basis of
approval for Selzentry and is being used in every advanced CCR5 inhibitor
development program currently underway. In addition to calling
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