Molecular Studies Services
Genotypic characterization of resistance mechanisms is critically important for bacterial and fungal isolates tested during the pre-clinical and clinical phases of development of antimicrobial agents. This information is becoming part of the relevant dialogue surrounding the clinical application of an antimicrobial and it is highly anticipated by scientific, regulatory and health providers to identify the strengths of a drug and possible limitations in the therapeutic setting. Our team of experts has charted the epidemiology of resistance mechanisms to several antimicrobial agents and can fully describe the resistance and virulence genes, as well as molecular typing for referred isolates through our clinical trial services or through our surveillance programs.
How are the studies organized?
Our team can develop and apply screening algorithms to identify isolates that should be selected for further molecular workups for clinical trials or incorporate those into our surveillance programs. Once algorithms are developed, we will research and develop the appropriate assays to find the answers needed to what is causing these resistant patterns, to determine the genetic relatedness of isolates from the same species or to understand the virulence factors in certain pathogens.
What are the design and support services available?
Many different testing methodologies can be employed, including rapid molecular assays that are commercially available or developed in-house, PCR amplification of particular genetic targets and Sanger sequencing-based methods. Additionally, gene and protein expression assays to describe intrinsic resistance mechanisms against all antimicrobial classes can be performed.
The introduction of next-generation sequencing (NGS) methods has become a very powerful tool to completely define the genome. Further, JMI Laboratories has the NGS equipment and information technology capabilities to query these genomes against curated libraries of resistance genes at a fraction of the time it would take utilizing conventional methods.
What is the end goal?
Clinical Regulatory Data – The regulatory authorities are placing significant importance on the inclusion of molecular information to support the microbiology identification and susceptibility data in clinical trials. Isolates that may be phenotypically described as resistant or that come from a patient with a treatment failure will need to be characterized as to the potential reasons for resistance, clinical failure or to determine the genetic relatedness of multiple isolates from the same patient. With the significant financial investment in clinical trials, it is vital that the chosen molecular microbiology vendor has demonstrated significant expertise in this field.
Antimicrobial Development – As your drug progresses in the various stages of development and especially after receiving approval, you will need to be able to fully understand the specific strengths of your drug and also be able to communicate any potential limitations in therapy. Only through a fully complete molecular profile will you be able to introduce an effective communication and marketing plan to health care providers on the clinical utility of your agent.
Organism Library – One of the outcomes of the investment in molecular support services for our surveillance programs is that our isolate collection library now contains thousands of highly characterized isolates. These strains with described mechanisms of resistance can be used to challenge newer agents to define the spectrum for In Vitro Activity drug development studies.
The JMI Laboratories Difference
Our molecular team has significant expertise in the characterization of resistance mechanisms for antibacterial and antifungal agents, in the epidemiological evaluation of resistance patterns and search for virulence genes. We have supported numerous clinical trials, and performed the characterization and construction of isolates for downstream testing during the different phases of drug development for new compounds. Our investment in new technologies, including NGS, and large numbers of publications in this field, demonstrates our commitment to high scientific standards and experience that can be applied across many services lines.