EVERYONE IN THE CLINICAL LAB BUSINESS KNOWS that our business will soon be dominated by genetic and molecular testing technology. However, most lab administrators and pathologists believe that we are several years away from the widespread clinical use of such technology in laboratory testing.
In principle, I would agree with that part of the popular wisdom. Widespread clinical use of genetic and molecular test technology is probably five years away. But I predict that there exists today a “killer application” technology in someone’s research lab that will find its way into diagnostics and transform at least one important area of laboratory medicine. My premise is simple: whatever this “killer application” technology is, its potential to outrageously improve the current medical standard of care will cause it to “fast track” through clinical trials and regulatory approval. Laboratories will find themselves with a new clinical tool which doctors want.
Ask me what this technology is and I cannot answer. My business intuition sifts through the cascade of announcements concerning genetic-based discoveries and tells me that something big is lurking beneath the public eye. When this scientific breakthrough surfaces, its impact will be swift and pervasive.
But let me offer just one example of how new discoveries in genetics are leading us to a diagnostic testing revolution. Last week, researchers at Gemini Genomics PLC and Sequenom Inc. reported that they had identified a pair of previously unknown genes which seem to play an important role in heart disease. Using genetic data gathered from thousands of pairs of twins, the two companies found one gene which appears to be associated with high cholesterol levels, and another gene which appears to be related to high density lipoprotein (HDL). The companies are preparing to license this knowledge to pharmaceutical and diagnostic companies for the purpose of developing drugs and lab tests to identify and treat various forms of heart disease.
This announcement is just one of a steady stream. We are in the early stages of the exponential curve for genetics-based medical procedures and diagnostic tests. It demonstrates why I predict that the tidal wave of genetic and molecular diagnostics is much closer than any of us understand.