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<img border="0" src="images/04subleft.gif" width="474" height="88" alt="The Mark of Individualized Medicine"> monogram biosciences
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HIV and Other Infectious Diseases

Monogram focuses on developing new assays to evaluate HIV and improve treatment management. An assay to measure HIV's replication capacity (RC), or how efficiently it reproduces, can provide valuable information about how aggressively a patient should be treated. The successful development of new drugs in the entry inhibitor class requires unique drug resistance assays to assess the susceptibility of HIV, particularly multi-drug resistant HIV, to these new agents. In addition, an assay that can identify the co-receptor tropism of HIV has the potential to be used initially to select patients for clinical trials of entry inhibitors and, after regulatory approval, to determine if a patient is an appropriate candidate for the drug.

In response, we have developed assays for evaluating HIV RC, HIV entry inhibitor susceptibility and HIV co-receptor tropism:
  • Replication Capacity® HIV: Provides a rapid and accurate method for evaluating a particular virus' RC

  • PhenoSense® HIV Entry assay: Monogram engineered phenotypic technology for clinical trials of entry inhibitors (used in the development of FUZEON)

  • PhenoSense HIV Co-receptor Tropism assay: Evaluates the co-receptor tropism of HIV (X4 or R5 virus) to assist in managing antiretroviral therapy. The tropism assay looks at the surface receptors on HIV to determine the dominant co-receptor, and is currently being used by several pharmaceutical and biotechnology companies in the development of HIV entry inhibitors
Oncology

Despite many years of clinical studies, physicans often do not have adequate information to predict how a patient will respond to a given therapy. In addition, many of the newer, more targeted drugs, which generally have less severe side effects, have low response rates in the general disease population, although they can be extremely effective in a subset of that population. Predictive tests able to measure the drug targets in their activated state (i.e., those target proteins actively involved in the disease process or mechanism affected by the drug) will be especially valuable.

Monogram's VeraTag® oncology assays enable detailed analysis of activated protein drug targets and signaling pathways in cancer cells, including samples that are formalin-fixed and paraffin-embedded, which is the standard preparative method for tumor samples in most pathology labs. These assays are intended to be used to help physicians better determine whether certain therapies are appropriate for individual cancer patients, and whether to combine therapies with different mechanisms or properties. The first commercially available activated receptor test panel based on VeraTag technology, focused on the EGFR/HER receptor family, is scheduled for introduction in 2006. In addition, the assays can benefit pharmaceutical and biotechnology companies developing oncology drugs by providing information on a drug's mechanism of action, selectivity and potency in a biological setting in pre-clinical research, and enabling enrichment or selection of clinical trial populations later in the drug development process.

Learn more about Monogram's HIV products.
Learn more about Monogram's VeraTag applications.
Learn more about Monogram's pharmaceutical partnerships.
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