What is PhenoSense® Integrase?
The PhenoSense® Integrase assay is a phenotypic resistance test used to determine the susceptibility of a patient's HIV to integrase inhibitors. Integrase inhibitors block HIV replication by preventing the virus from integrating its genome into the host cell’s DNA. Raltegravir is the first approved drug in this new class of HIV antiretrovirals.
How does the PhenoSense® Integrase assay work?
PhenoSense® Integrase is a new assay based on Monogram Biosciences' platform technology, PhenoSense®.Using a small blood sample, PhenoSense® Integrase is performed by amplifying the patient's HIV integrase coding region and using it to make HIV particles that include integrase specifi c to that individual's virus. These HIV particles are used to infect cell lines in the presence of integrase inhibitors. Once the virus infects the cell and undergoes a single round of replication, the reporter gene-luciferase-can be expressed, which produces a quantitative signal. This signal identifies the level of susceptibility of the patient's virus to integrase inhibitors.
How are the PhenoSense® Integrase results interpreted?
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The PhenoSense® Integrase test results are provided in a simple, easy-to-understand report (inset). The report will clearly indicate whether a patient's virus is susceptible to the integrase inhibitor. |
Does Monogram offer a genotypic test for integrase resistance?
Integrase inhibitors represent a new class of antiretrovirals and predictive genotypic algorithms are not fully defined at this time. Currently, Monogram is offering a phenotypic resistance assay that is accurate, precise, and robust.
Will the PhenoSense® Integrase assay be covered by payers?
Monogram Biosciences is working directly with providers and payers. Many policies are in place regarding coverage, and Monogram will work with any patient on coverage and reimbursement. Please call Monogram's Gateway Line at 1-877-436-6243 with coverage and/or reimbursement questions.
Reference: 1. Performance characteristics and validation of the PhenoSense HIV Integrase Assay. Poster presented at: 48th Annual InterscienceConference on Antimicrobial Agents and Chemotherapy (ICAAC)/46th Annual Meeting of the Infectious Diseases Society of America (IDSA); October 26, 2008; Washington, DC.