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PhenoSense Integrase along with other Monogram assays were used to supportthe clinical trials of the first commercially-available integrase inhibitor,Merck's Isentress(TM) (raltegravir), which received U.S. Food and DrugAdministration (FDA) approval in October 2007. In Merck's phase III BENCHMRKtrials, Monogram's PhenoSenseGT was used to select optimized drug regimens inthe placebo and Isentress-containing treatment arms while PhenoSense Integrasewas used to identify and characterize Isentress resistant viruses in treatmentfailures. The company is also actively involved in the clinical evaluation ofGilead's integrase inhibitor candidate, elvitegravir, currently in Phase IIIstudies. In addition to drug resistance, PhenoSense Integrase also measuresreductions in viral replication capacity associated with integrase inhibitorresistance that may help characterize viral fitness.
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"Using new antiretroviral drugs correctly today, including HIV integraseinhibitors, is critically important since the pipeline for additional newagents is not likely to provide treatment options beyond our current choicesfor a number of years," said Dr. Charles Hicks, Associate Professor ofMedicine at Duke University Medical Center. "Tools like HIV resistancephenotype tests (including Monogram's PhenoSense Integrase and PhenoSense GTassays) and the HIV tropism assay (Trofile(TM)) are important tools to helpclinicians make good choices. They can also help with modifying regimens thatare not suppressive by determining whether additional resistance has emergedand which drugs are no longer active."
"As the first and only commercially available assay to measure integraseinhibitor resistance, PhenoSense Integrase exemplifies Monogram's leadershipposition in personalized medicine and the Company's continued commitment todevelop innovative HIV diagnostics that tailor drug treatments to theindividual patient," said Monogram CEO William Young. "As evidenced by today'sproduct launch and last year's introduction of Trofile, Monogram is firmlycommitted to ensuring that cutting-edge diagnostics are readily available tomeet the needs of patients and physicians."
The performance of the PhenoSense Integrase assay is validated incompliance with regulations specified by the Clinical Laboratories ImprovementAmendments (CLIA) and is performed in Monogram's Clinical ReferenceLaboratory, which is accredited by the College of American Pathologists (CAP).
About PhenoSense Integrase Assay
PhenoSense Integrase determines the susceptibility of a patient's HIV-1strain to integrase inhibitors. The region of the HIV genome that encodesintegrase is amplified from a patient blood sample and inserted into aproprietary test vector that is used to generate virus particles thatreplicate using the patient virus integrase protein. Completion of a singlereplication cycle results in the production of luciferase activity in infectedcells. Infection in the presence of drug is performed to determine whether apatient virus is sensitive or resistant to integrase inhibitors. Based on theamount of luciferase activity produced in the absence of drug, PhenoSenseIntegrase also provides a measure of replication capacity (RC) of integraseinhibitor sensitive and resistant viruses.
About Monogram
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