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Increasing Clinical Trial Success

Super-precision genetic-based design increasing efficacy

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.

Five Facts

  1. 46 % of recent drug approvals have a genotype on the label

  2. Many genetic variants have similar effects on gene function

  3. Precision clinical trials can be scaled to use a whole gene

  4. Experiments are better than artificial intelligence

  5. Decrease project risk and clinical trial costs

Since most clinical trials fail, the world needs a better design

Trials based on whole gene genotyping are more comprehensive than a single genetic marker

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.

Join the functional genome revolution!
Reach out today for more information.
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