Technology Overview

Population Diagnostics (PDx) has developed a technology for the rapid, systematic and high throughput discovery and validation of causative genetic biomarkers. “Causative” biomarkers are the only biomarkers which can be used to develop predictive tests because they represent certainty that an explicit genetic condition is present or it will eventually develop in a patient. PDx is establishing the industry standard by defining and bringing to market the clinical value of a “causative” biomarker as the key ingredient of a diagnostic test.

PDx’s technology solves the major problem which has hindered the industry’s ability to transform biomarkers into meaningful clinical products. On a weekly basis numerous genetic discoveries are reported. The reality of the post genome era is:  Novel DNA biomarkers that are being revealed today are derived from obsolete and statistically flawed methods and their clinical value is negligible.  This class of biomarker, termed as “predisposition”, “risk factor” or “susceptibility” indicators, cannot be used as a predictive test ingredient primarily because the very same biomarkers are found too frequently in “normal” people – those who do not have the disease nor any chance of ever developing it.  “Predisposition” or “risk factor” indicators at best provide only a hint that a patient has a higher statistical chance that a disease will occur. Without definitive information, predictive tests derived from this class of biomarker will cause physicians and patients to make medical, dietary and quality of life decisions which are baseless. If used by pharmaceutical companies, their resulting drugs will not be effective or safe in the majority of eligible patients.

The dominance of PDx’s core technology is based on the comprehensive understanding of “normal” human variation in very large heterogeneous populations. PDx recognizes that humans are not 99.9% genetically similar as originally thought and this is exclusively incorporated into PDx’s technology. Generally, PDx’s biomarker discovery and validation tools are based on the genome-wide understanding of 10,000 normal individuals across all major ethnicities, creating the genetic definition of the meaning of “normal”. The micro-chip platform, along with proprietary methods, processes and algorithms together account for the precise level of genetic diversity in the population at large. Therefore, given any set of DNA patient samples classified for a either a disease or a drug study,  PDx can rapidly and systematically exclude all the genetic information found frequently in the normal population, revealing the remaining genetic information which is causative and clinically relevant.