Over the past decade, there has been strong growth in precision clinical trials with 46% of approved drugs having a genetic biomarker on the label. These drugs rely on a genetic variant that codes for an amino acid mutation that either inactivates or activates a gene. However, this mutation is only present in a percentage of tumors and there are likely many other mutations that have a similar impact on gene function and disease. The problem is that it is very labor-intensive and takes a long time to identify all of these other genetic variants of concern, so these variants are not considered in clinical decisions. This is where Heligenics empowers a superior design of clinical trials with its Gene Mutation Libraries (GMLs) measuring the impact of each genetic variant in a GigaAssay experiment. Comparisons to GMLs from cells treated with drugs can identify resistance mutations.
Now, all these GML variants can be used to segregate patients in a clinical trial. We call this new data-driven approach to clinical trial design Super-precision clinical trials since they are expanding on the precision clinical trials that have become routine practice.