Technology evaluation: A critical step in the clinical utilization of novel diagnostic tests for liver fibrosis.

摘要

Novel technologies are appearing throughout medicine and this is equally true for Hepatology. In particular there has been an explosion of new serological and radiological tests for the non-invasive diagnosis of liver fibrosis related to HCV [1-10]. The need for non-invasive tests and the performance characteristics of such tests have been extensively described and putative ideal biomarkers have been delineated . However, the clinical reality is markedly different from many of the research studies reported and the clinician needs more validation of these biomarkers and their performance characteristics before they can be accepted into routine clinical practice [11,12]. Additionally, there has also been a significant regional difference in the routine uptake of biomarkers for fibrosis, with the European countries much more accepting of their clinical utilization than in the United States. Much of this discrepancy is related to the lack of validation of these tests in the US, the lack of FDA approval andthe reluctance of 3rd party payers to reimburse for these tests. Current utilization of serological tests in the US is low but anticipated to increase with the commercial availability of three tests; HepaScore, FibroSpect and FibroTest. The cost of these tests is certainly acceptable at approximately dollar300 and more reimbursement is becoming available. FibroScan is neither FDA approved nor widely available outside of research in the US. The first critical step in increasing utilization is large scale, vigorous scientific validation of the performance characteristics of novel tests and procedures.