Research & Development Strategy

In the search for SNPs predictive of improved outcome for activated protein C-treated patients, the Sirius team has built a powerful methodology. The rigorous three-phase research and development strategy mirrors the process for drug development including discovery, replication and validation.

Discovery: Sirius uses a variety of genomic techniques to hone its hypothesis SNPs, including Candidate Gene Analysis, Genome Wide Association Studies and Bioinformatics. We derive initial SNP correlations (hypotheses) using proprietary databases and patient cohorts using candidate gene analysis and Genome Wide Association Studies (GWAS). New hypothesis SNPs are then selected to be tested in a replication study.

Replication: Replication studies provide additional data to confirm our genetic association hypotheses and further increase certainty by testing for associations present in completely independent patient cohorts. In addition to determining a statistical association, Sirius’ researchers look at SNPs using bioinformatics to understand from a biological point of view if they could logically be involved with the disease and with response to the therapeutic drug. This work allows the team to select the best possible hypothesis to test in a much larger validation study.

Validation: Findings from the replication studies are verified using clinical data from large cohorts gathered from multiple participating institutions across the world, to correlate genotype with a differential drug treatment effect.

Sirius then develops in-vitro diagnostic (IVD) kits based on responsive genotypes to aid in drug administration decisions.