Challenges for Theranostics
Despite these promising benefits, the use of companion diagnostic for personalized medicine applications will not have an easy route to and through the market.
First, the molecular diagnostic tests associated with companion diagnostics face the challenge of a healthcare finance system that has become dependent on visible disease symptoms and gross clinical classifications.
Simultaneously, the ability to classify diseases into distinct molecular subcategories challenges traditional pharmaceutical business models that focus on one-size-fits-all drugs. As a result, the economic rationale for personalized medicine in healthcare decisions needs to be based on the cost-savings that result from proactive and preventive interventions.
Second, physicians have an uneasy relationship with clinical diagnostics as it is. Despite the fact that they need this information to properly diagnose their patients, it is an aspect of their practices that is beyond their control. Physicians, by their very nature, must feel in control of the patient’s care. What companion diagnostics and personalized medicine are asking them to do is to accept direction in prescribing for their patients. If that direction is contrary to their experience, it raises conflict.
The third key issue is that of privacy. Currently, the legal picture regarding medical privacy issues that may affect personalized medicine and companion diagnostics is a patchwork of federal, state, and local laws. HIPPA not withstanding, these offer various levels of protection against the misuse of genetic information.
Biomarker discovery is another issue. Companion diagnostics have largely been the product of biomarker discovery. The identification of biomarkers, however, has mostly been a one-at-a-time approach. Many of the well-known biomarker assays have been identified based on clear biological insight from genetics, physiology, or biochemistry. As a result, only a few markers at a time have been considered for development. While genomics and proteomics are providing strong bases for biomarker discovery, the process is still a laborious one that experiences significant technical difficulties.
Finally, at a time when the healthcare system is seeking cost containment, companion diagnostics introduce new complexity into successful diagnosis. Complex genetic relationships (i.e., multiple affected genes) and rapid mutational states present key problems for companion diagnostics.