Monogram's PhenoSense GT HIV assay more cost-effective than genotyping alone, study says

By Angela McDaniels

Seattle, Dec. 15 - Monogram BioSciences Inc. said recent studies continue to support the value of its assays for the treatment of HIV.

Data demonstrate that the combination of HIV phenotype and genotype testing using PhenoSense GT is cost-effective compared with genotyping alone, the company said.

This study was designed to determine the cost per quality-adjusted life year and incremental cost-effectiveness of phenotype and genotype testing compared with genotype testing alone.

"Chronic management of HIV infection is a complex endeavor that must address a variety of factors, including viral resistance profiles, patient preferences and health care economics," investigator Andrew R. Zolopa of Stanford University said in a company news release.

"The use of combination genotypic and phenotypic information to create successful treatment regimens is advancing the management of HIV infection. These data show that in treatment-experienced patients, the use of a comprehensive set of phenotypic and genotypic data improves health care economics and patient care and is an essential component of antiretroviral therapy."

Another study described the validation and performance characteristics of PhenoSense Entry and concludes that the assay is an important new tool for the development of novel fusion inhibitors and the selection and monitoring of antiretroviral treatment regimen, the company said.

The study included a case report of a patient who experienced rapid progression to AIDS after infection with a multi-drug resistant, dual-tropic strain of HIV. Longitudinal analysis with Monogram's Co-Receptor Tropism assay over two years revealed evolution of viral tropism from a more pathogenic virus using the CXCR4 co-receptor to a less pathogenic strain using the CCR5 co-receptor.

The report underscores the importance of viral tropism studies in understanding how HIV tropism impacts progression to AIDS, the company said.

PhenoSense Entry is the only commercially available phenotypic susceptibility assay for entry inhibitors, a new class of HIV therapies that inhibit the virus' ability to enter cells, the company said.

The assay is used to support development of entry inhibitors and to guide treatment of HIV-infected individuals.

The data was detailed in abstracts presented at the 45th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy in Washington, D.C.

"Monogram is committed to leading the development of innovative and superior assays for improving the treatment of HIV," chief executive officer William Young said in the release.

"PhenoSense GT provides comprehensive information critical to guiding the selection of optimal therapeutic treatment regimens for patients and we have demonstrated that this approach has superior cost-effectiveness compared with genotyping alone."

Monogram's HIV tests have been used in the clinical trials of every drug approved for the treatment of HIV in the past five years, the company estimated. Monogram has active collaborations with almost all of the major pharmaceutical companies that are developing HIV drugs.

"Our assays are enabling the pharmaceutical industry to innovate new HIV treatments more effectively, which should help speed new therapies to market," Young added.

Monogram, formerly ViroLogic Inc., is a South San Francisco, Calif.-based company that develops products to guide and improve treatment of serious infectious diseases and cancer.

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