Monogram Biosciences' HIV Tests - Providing information to help patients get the most from antiretroviral therapy
The treatment of HIV is difficult for individuals who live with complex treatment regimens, side effects, and drug resistance. It is also a challenge for healthcare providers who work to make sure their patients are getting the right drugs, finding ways to cope with side effects, and most importantly, staying healthy.
Monogram Biosciences, Inc. is the leading provider of HIV tests that help manage the complexities of antiretroviral therapy. PhenoSense GT®, PhenoSense® and GeneSeq®, have for many years helped healthcare providers choose the drugs that will provide the greatest benefit to individual patients. More recently PhenoSense Entry® and PhenoSense® Integrase have been added to our testing menu, mirroring the increased breadth of classes of HIV drugs. Monogram Biosciences' new gold-standard tropism test, Trofile™, is accurate, precise, sensitive, reproducible and robust in the measurement of HIV-1 co-receptor tropism.
Trofile™ (HIV Tropism Test)
Trofile has been clinically validated through use in phase II and phase III clinical studies to select patients for treatment with the class of CCR5 antagonist drugs. One such drug, Selzentry™ is available for clinical use and Trofile is the only clinically validated assay for selection of appropriate patients for Selzentry.
Current U.S. Department of Health and Human Services (DHHS) guidelines recommend that a co-receptor tropism test should be performed whenever the use of a CCR5 inhibitor is being considered. Co-receptor tropism testing might also be considered for patients who exhibit virologic failure on a CCR5 inhibitor.
PhenoSenseGT®
PhenoSenseGT combines phenotype and genotype drug resistance results in a single report. PhenoSenseGT also includes a measure of replication capacity (RC), sometimes called viral fitness and HIV-1 subtype.
Choosing PhenoSenseGT after 2 regimen failures allows healthcare providers to retain options in patients' drug-regimen strategy that may preserve drug choices for a later time. While sophisticated in its technology, PhenoSenseGT remains user-friendly. The report form includes updated upper and lower clinical cutoffs and a summary page.
Even in complex cases, PhenoSenseGT brings clarity to healthcare providers' treatment choices. Both phenotypic and genotypic results come from the same blood sample, so it is possible to resolve disagreement between them. This comprehensive test gives healthcare providers advanced, practical insight into viral susceptibility.
PhenoSense®
PhenoSense offered as a single HIV drug resistance test or in the combination test, PhenoSenseGT, represents cutting-edge resistance testing technology. PhenoSense provides the most accurate quantitative measurement of susceptibility to individual drugs. PhenoSense drug resistance results are provided with a measure of viral fitness or Replication Capacity (RC).
The PhenoSense 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).
GeneSeq®
GeneSeq 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 Biosciences' resistance experts.
The GeneSeq 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 PhenoSenseGT (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 test 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 assay for integrase inhibitors.
PhenoSense Integrase is used to characterize Isentress® (raltegravir) - resistant viruses in patients with treatment failures.
Replication Capacity (RC)
Replication Capacity measures how well a patient's virus is able to replicate compared to a wild-type reference virus. Although drug resistance mutations enable viruses to replicate in the presence of a drug, they may do so at some fitness cost to the viruses. Understanding how fit a patient's virus is may provide insight in a highly complex case; Replication capacity can help make decisions about when to delay, start, stop, switch or interrupt therapy. Replication Capacity is included with PhenoSenseGT, PhenoSense, and PhenoSense Integrase.