Download Strategic Partnerships in Drug Development and Clinical Trial

Strategic Partnerships in
Drug Development and Clinical Trial Assays
Monogram Biosciences®, a LabCorp company, has a legacy of providing high-throughput, innovative
assays for HIV and HCV.
HIV
In HIV drug development and clinical trials, Monogram’s proprietary technology can assist
clients with their resistance testing needs, from early-stage compound screening to Phase IV.
Protease and Reverse
Transcriptase Inhibitors
Neutralizing Antibodies for
Vaccine Development
PhenoSense GT® (combination phenotype and
genotype assay)
– PhenoSense GT is a resistance test that
combines three tests, PhenoSense HIV,
GeneSeq® HIV and Replication Capacity (RC) to
make up one complete picture of drug resistance.
• PhenoSense® (phenotype assay)
– Monogram’s flagship assay and core technology,
PhenoSense HIV is a widely used phenotypic HIV
drug resistance assay.
• GenoSure MG® (genotype assay)
– In this novel assay, GenoSure MG combines
LabCorp’s rapid turnaround genotype with
Monogram’s proprietary algorithm.
• Monogram has applied its phenotype technology to
assist clients in their HIV vaccine development
efforts, therapeutic antibody research and studies of
natural history of infection. Sequencing on clones is
also available.
•
Entry Inhibitors
Trofile® (Tropism); Trofile ES, Trofile DNA
– Tropism testing before initiation of therapy with a
CCR5 antagonist is recommended in the 2011
DDHS guidelines.
• PhenoSense Entry®
– A phenotypic measure of resistance for all
classes of entry inhibitors, including co-receptor
antagonists, attachment inhibitors, and fusion
inhibitors.
• Envelope Sequencing (V3, gp41, gp160)
– In clinical trials, Monogram can sequence the V3,
gp41, or full gp160 regions of the HIV envelope.
•
Gag
• For companies developing Gag/Assembly Inhibitor
compounds, Monogram’s Gag phenotype and
genotype can measure susceptibility/resistance to
this class of inhibitors.
Pre-clinical/Post Marketing
• Querying Monogram's database of genotypic and
phenotypic results
• PhenoScreen® – antiretroviral compound screening
• Novel drug studies for characterizing a specific
compound’s resistance profile
• Clonal Analysis – measuring the resistance profile
of individual viral clones
Integrase Inhibitors
•
•
Phenosense Integrase
– Monogram Biosciences' PhenoSense RH/IN
assay is a novel phenotypic assay that measures
the susceptibility of viruses to inhibitors of HIV-1
Integrase and RNaseH, as well as the replication
capacity of viruses with reduced susceptibility to
such inhibitors.
GeneSeq Integrase
– A genotypic measurement of susceptibility to the
Integrase inhibitors.
www.monogrambio.com
In Virology Drug Development,
Monogram Is a Proven Partner
HCV
Monogram has developed a suite of tests addressing each of the key HCV antiviral drug development
targets. Additionally, Monogram is offering other needed assays, making Monogram a one-stop shop for
a client’s HCV testing needs for drug development.
Antiviral Drug Resistance
• Genotype (Gene Sequencing) and Phenotype testing for:
–NS5B
Monogram has dedicated data management,
–NS3/4a
clinical research, R&D and clinical project
–NS5A
management teams to help you interpret data
–Clone isolation and analyses
–Resistance characterization against virus panels
and respond to regulatory requirements.
IL28B
• Single Nucleotide Polymorphism (SNP) rs12979860
• Please inquire on availability of other SNPs
HCV Viral Load Testing
• Quantitative real-time PCR
HCV Genotyping
• Subtype determination
For more information on Monogram assays and capabilities, please visit
www.monogrambio.com or contact us at [email protected].
345 Oyster Point Blvd. South San Francisco, CA 94080 1-800-777-0177 www.monogrambio.com
© 2011, Monogram Biosciences, Inc.