How have developments in molecular diagnostics and pharmacogenomics affected assay development?
In my opinion, diagnostics developments using the polymerase chain reaction (PCR) and related methods will have an impact primarily in the field of infectious diseases. Immunoassays for detecting HIV or a specific antigen can easily be created by using classical methods. More and more molecular diagnostic reagents have come onto the market in recent years. Instead of detecting an antibody or antigen, these types of tests bind the nucleic acids from the cells and amplify them through PCR or a similar method. The infectious disease is then detected and computed using the content of nucleic acid. But for cardiac markers, endocrinology, drugs of abuse, or fertility tests, molec-ular diagnostics is not having much of an effect on assay development. These are sophisticated methods. Of course, they are already being used by many hospitals. But I cannot think of any IVD manufacturers that are poised to offer a large menu of assays that use this kind of technical approach. In March of last year
