Opal Clinical Trials


Advances in next generation sequencing technology and significant cost reductions are opening the door to leveraging genomics and personalized medicine in clinical trials. Using Opal™ Clinical Trials, you can apply Omicia’s robust genome analysis tools to the development of new biomarkers for diagnostics and therapeutics. Omicia applications for clinical trials include genomic classification of patients likely to benefit from new drugs, development of validated assays for genomic classification and design of more focused trials to test efficacy of new therapeutics.



Advanced genome analysis tools

Omicia’s genome analysis tools are fast, robust and scalable. Genome annotation is fully automated, and supports both exomes and full genomes. Omicia’s Clinical Trials solution is built on Omicia’s proven proprietary Opal platform and genomic knowledge database which includes interactive analysis tools for identifying SNVs, indels or more complex genomic signatures of interest, support for in silico panels, and allows full data export to facilitate further analysis or integration with other study data. The platform is fully scalable and can handle hundreds to thousands of genomes per month.
Omicia Clinical Trials includes VAAST, Omicia’s award winning, published algorithm for disease-gene and variant identification and ranking. VAAST enables cohort analysis within a Clinical Trial context. Additional features relevant for production genome analysis include standardized quality assurance (Omicia Clinical Grade Score) to evaluate a genome sequence quality. Each variant is classified and annotated by mutation type, frequency and severity of impact on protein function including the Omicia Variant Impact Score, a proprietary metaclassifier that aggregates variant scoring algorithms providing more accuracy across larger numbers of variants. Available literature annotations from OMIM, ClinVar, Locus-Specific Databases, and GWAS are also provided.

 


Genomic classification of patients likely to benefit from new drugs

Clinical trial participants can be segmented based on genomic profiles and observed therapeutic response to discover potential biomarkers, or confirm their clinical validity. Participants can be screened using specific panels of genes and variants as well as entire exomes or genomes, to identify patients with a specific genomic signature. Panels can screen participants based on pharmacogenomic activity, and genes up- or down-regulated by existing drugs can be analyzed. In addition, genomic profiles can be correlated with gene expression data to understand pathways and confirm the genetic basis of gene expression.

 


Development of validated assays for genomic classification

The success of Genentech’s HER2 diagnostics and Trastuzumab has generated interest in co-developing drugs and companion diagnostics. Genomic biomarkers within a trial cohort can be identified, targeted, and screened for as part of the development of diagnostic assays.

 


Design of more focused trials to test efficacy of new therapeutics

Micro-segmentation in clinical trials is growing. When disease subtypes are already known, smaller clinical trials can be designed, and only those with a particular genetic signature recruited. Benefits include lower program costs and higher potential for drug efficacy with fewer adverse events.

 

 

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