Monogram Biosciences can provide its clients with validated cumulative data in the form of an electronic data deliverable (EDD) in support of New Drug Application (NDA) and other regulatory submissions.

Monogram’s HIV assays can be ordered through your Monogram account by using a test requisition form directly or through a Labcorp service provider. Download a sample copy of Monogram’s test requisition form below.

Monogram is committed to offering molecular and cell-based assays to support the HIV Curative Strategy effort. Monogram is highly proficient in developing validated, high-complexity, and high-throughput antiviral drug resistance assays.

Monogram offers proprietary VeraTag technology for oncology and the industry’s first fully quantitative HER-2 protein test, HERmark®.

Monogram has expanded its expertise in virology and base phenotyping technology to address the need for high-throughput, quantitative resistance testing assays for various respiratory and other viral illnesses.

Services for clinical trials include: Early development, pharmacodynamic, and mechanism-of–action (MOA) studies. Biomarker detection and quantification in tumors and blood samples (PBMCs).

Monogram has three assays that sequence and analyze the PR, RT, and IN regions of the virus, providing information on four classes of drugs, protease inhibitors (PIs), nucleoside reverse transcriptase inhibitors (NRTIs), nonnucleoside reverse transcriptase inhibitors (NNRTIs), and integrase inhibitors (INIs):

Monogram has a number of tests, both phenotypic and genotypic, that focus specifically on determining resistance to drugs that target products of the PR/RT region of HIV-1 POL.

Monogram has developed and provides both genotypic and phenotypic assays for assessing resistance to drugs that target the three main steps of the HIV viral entry process.

Monogram provides viral load reflex testing options to facilitate this process. We can perform a viral load test and then automatically run a resistance and/or tropism test if the patient’s viral load meets or exceeds the viral load thresholds for the chosen assay.