Super-precision Clinical Trials
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 mutation effect on gene activity (MEGA-Map™) measuring the impact of each genetic variant in a GigaAssay™ experiment. Comparisons to MEGA-Map™ from cells treated with drugs can identify resistance mutations. Now, all these MEGA-Map™ variants can be used to segregate patients in a clinical trial. We call this new data-driven approach to clinical trial design a Super-precision clinical trial, since it expands on the precision clinical trials that have become routine practice.
46 % of recent drug approvals have a genotype on the label
Many genetic variants have similar effects on gene function
Precision clinical trials can be scaled to use a whole gene
Experiments are better than artificial intelligence
Decrease project risk and clinical trial costs
Trials based upon whole gene genotyping are more comprehensive than a single genetic marker
Since most clinical trials fail, the world needs a better design
Heligenics is helping drug manufacturers scale the use of a genetic biomarker to a whole gene biomarker. Recent examples show that although only a few variants may be in clinical practice, there are at least 100s of variants in a gene with a similar effect that are not yet being used. The successful precision drug trial concept can be scaled to use all mutations in a target gene with a Heligenics MEGA-Map™.
Unlike AI, this revolutionary technology is based on experimentally derived, not theoretical data – allowing you to identify which subjects are unlikely to respond, therefore significantly increasing power and improving the odds of meeting outcome goals.