New assay development should be directed toward answering fundamental
clinical questions. Caveats that must be considered before initiating
assay development projects are: New assays should allow the clinician
to interact with and treat a patient more effectively, thereby improvi
ng medical outcome; and new assays should facilitate recapture of syst
em resources, enabling cost savings or reinvestment of resources. Defi
ning the clinical questions and consideration of the caveats permit a
means of prioritizing assay development activities. Laboratorians are
faced with evaluating several types of development activities that lea
d to assay implementation in routine clinical testing. Assays can be p
rioritized for up-grading to newer cost-effective technologies, provid
ed the changes maintain or improve analytical and clinical performance
. Predicting which research assay will have future value is difficult
when clinical performance is not fully validated. However, such assay
development has the greatest potential for changing the delivery of he
althcare by a clinician.