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PhenoSense® Integrase
PhenoSense® Integrase is the first and only commercially available, phenotypic resistance assay to measure susceptibility to integrase inhibitors.
Features and Benefits
- Validated to be accurate, precise, sensitive, reproducible, and robust in the measurement of susceptibility to integrase inhibitors 1
- Used in clinical studies of raltegravir (Isentress®) to identify and characterize raltegravir-resistant viruses in patients with treatment failure
- Based on Monogram’s proven PhenoSense® platform technology and dedication to understanding HIV-1 drug resistance
- Together with PhenoSense GT® and PhenoSense Entry®, PhenoSense® Integrase provides the most complete picture of resistance to antiretroviral medications
- Because it provides a direct measure of a patient’s HIV-1 susceptibility to integrase inhibitors, PhenoSense® Integrase is providing phenotypic resistance analysis in a variety of clinical trials (Table 1)
- PhenoSense® Integrase is also being used with several other compounds in Phase I and II clinical trials
Table 1. PhenoSense® Integrase Clinical Trial Use
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 fi rst 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 identifi es the level
of susceptibility of the patient’s virus to integrase inhibitors.
How are the PhenoSense® Integrase results interpreted?
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 defi ned 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 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)/46th Annual Meeting of the Infectious Diseases Society of America (IDSA); October 26, 2008; Washington, DC.
Should you have any questions regarding Phenosense® Integrase please call Monogram’s Client Services Group at 1-800-777-0177.
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