Role of the Opportunity To Test Index in integrating diagnostics with therapeutics

Abstract

In theory, the introduction of a novel test to accompany a therapy should be simple and automatic. However, In reality, the marriage of a test with therapy will not be a simple one, since each industry operates with its own distinct business model. Of concern to the pharmaceutical industry is the potential commercial dependency of a drug on the performance and implementation of a diagnostic. These concerns are justified since the history of diagnostic tests is frequently one of under use. One of the factors cited by Rogers is the issue of how complex an innovation is to administer. Rogers demonstrates that an innovation that is difficult to administer will be implemented more slowly or be discontinued by the user group it was intended for. It is the author’s view that understanding this micro interaction, experience and barriers of testing with the individual provider, in short the complexity of the test, will, in turn, provide those in the pharmaceutical industry with a methodology to consider their risk or exposure to a test upon which their therapy may become dependent in the US market. Since personalized medicine significantly marries the test and treatment decision, it is the perspective of the provider that will be paramount in determining which, if any, test is ordered and the subsequent clinical decision he or she is enabled to take upon the test response. Therefore, a focus of this perspective is to consider the issues of test implementation from the perspective of the US provider who will order and use the information they provide. The Opportunity To Test Index methodology is introduced, which the authors speculate may help quantify the level of risk a pharmaceutical company has to the complexity of a test upon which its therapy will be dependent. The methodology scores five key elements impacting test implementation: reimbursement, turnaround time, test administration, test interpretation and patient engagement.