Monogram Biosciences HIV Assays — Providing information to help patients get the most from antiretroviral therapy

The treatment of HIV is complicated. It is difficult for infected individuals who must live with complex regimens, side effects, drug resistance, and other issues, and it is a challenge for healthcare providers who work hard to make sure that their patients are getting the right drugs, finding ways to cope with side effects, and most importantly, staying healthy. Monogram has developed HIV tests, or assays, to help make the complexities of antiretroviral therapy easier to manage. Our phenotype and genotype resistance tests, phenotype + genotype combination test, and viral fitness test are intended to help healthcare providers choose the drugs that will provide the greatest benefit to the individual and to help get the most out of antiretroviral therapy over the long term.

Trofile (HIV Tropism Assay)
Trofile^® is a complex molecular assay that identifies the tropism of a patient's HIV. HIV tropism is determined by the co-receptors, CCR5 and CXCR4, utilized by the virus to enter a CD4+ cell. Over 23,000 samples have been tested using this assay and Trofile is regarded as the gold standard in commercial tropism testing. All trials of co-receptor antagonists have used Trofile in the clinical development. Trofile has been shown to be accurate, precise, sensitive, reproducible and robust in the measurement of HIV-1 co-receptor tropism.

Trofile DNA
Trofile^® DNA co-receptor tropism assay applies the proven performance of Trofile(R) to cell-associated viral DNA.

PhenoSense GT
PhenoSense GT^® gives you the complete picture of resistance. It's the only assay combining actual phenotype and genotype drug resistance results in a single report. PhenoSense GT^® also includes a measure of replication capacity (RC), sometimes called viral fitness, and HIV-1 subtype.

Choosing PhenoSense GT^® after 2 regimen failures allows you to retain options in your drug-regimen strategy that may preserve drug choices for a later time. While sophisticated in its technology, PhenoSense GT^® remains user-friendly. Our report form now includes updated upper and lower clinical cutoffs and a new summary page.

Even in complex cases, PhenoSense GT^® brings clarity to your treatment choices. Both phenotypic and genotypic results come from the same blood sample, so it's possible to resolve disagreement between them. This comprehensive assay gives you advanced, practical insight into viral susceptibility.

PhenoSense HIV
PhenoSense^® HIV is a phenotypic HIV drug resistance test and is the most widely used phenotypic test today. PhenoSense HIV is successful based on the quality of the test — utilizing proprietary leading-edge technology for a direct, rapid, and precise measure of a patient's virus' sensitivity to antiretroviral drugs. Test results allow healthcare professionals to review the level of susceptibility or resistance that a person has to each antiretroviral drug in order to design an individualized treatment plan. PhenoSense HIV drug resistance results are also provided with a measure of viral fitness, or Replication Capacity (RC).

The report form includes drug resistance information for all of the approved nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), and protease inhibitors (PIs).

GenoSure MG
GenoSure MG^® is a highly accurate genotypic HIV drug resistance test. The test is performed using state-of-the-art technology and the results are determined using the most recently updated HIV mutation information and information from scientific research and Monogram's resistance experts.

The report form includes drug resistance information for all of the approved nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), and protease inhibitors (PIs).

PhenoSense Entry
PhenoSense Entry^® is the only commercially available phenotypic test for measuring susceptibility to entry inhibitors.

Together with PhenoSense GT^® (our combination phenotype/genotype drug resistance test), PhenoSense Entry^® provides the most complete picture of resistance to antiretroviral medications.

PhenoSense Entry^® assesses resistance to Fuzeon^® (enfuvirtide), which interacts with glycoprotein gp41 of the HIV envelope. The assay also assesses resistance to entry inhibitors that interact with gp120 (eg, chemokine receptor antagonists, attachment inhibitors), and is used in their clinical development. It is the gold standard for assessing resistance to current and future entry inhibitors.

Alternative approaches may not account for the high genetic heterogeneity observed in this part of the virus.

PhenoSense® Integrase
PhenoSense® Integrase is the first and only commercially available, phenotypic resistance assay to measure susceptibility to integrase inhibitors.

• Validated to be accurate, precise, sensitive, reproducible, and robust in the measurement of susceptibility to integrase inhibitors.
• 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-1susceptibility to integrase inhibitors, PhenoSense® Integrase is providing phenotypic resistance analysis in a variety of clinical trials.

Replication Capacity (RC)
The Replication Capacity (RC) assay measures HIV's ability to make copies of itself, or replicate. RC testing is a way to measure the fitness of HIV. The test is performed by comparing an individual's virus to a reference, or wild-type, virus that is known to be good at making copies of itself. The wild-type virus has an RC of 100%. Knowing the RC of a patient's virus can help healthcare providers decide whether to delay, start, stop, switch, or interrupt treatment for the patient.

The RC assay is available with both the PhenoSense GT and PhenoSense HIV drug resistance assays. The RC results appear on the PhenoSense GT and PhenoSense HIV reports.