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As If Biomarker Discovery Isn't Hard Enough: The Consequences of Poorly Characterized Reagents

Year: 2013
Type: editorial
Abstract: The advent of high-throughput “-omic” technologies over the past 2 decades has driven a vast expansion in the search for clinical biomarkers, as manifested by the plethora of publications on biomarker discovery (over 8600) listed on PubMed since 2000. Unfortunately, the same time period has seen a relative dearth of clinically validated biomarkers that have received Food and Drug Administration clearance; only 10 new cancer biomarkers have been cleared by the Food and Drug Administration in the same time period (1). Although it is technically fairly straightforward to identify differentially expressed genes and gene products that are statistically associated with various clinical conditions, it is much more difficult to convert statistical associations into clinically useful biomarkers that meet the required performance characteristics of specificity, sensitivity, and reliability that are required for most clinical applications. This problem is particularly acute in the case of biomarkers for early detection of cancer, given the relatively low prevalence of many cancers and the substantial consequences of both false-negative and false-positive results. Early detection of ovarian cancer is a particularly illustrative example. The discrepancy in clinical outcome between stage I/II ovarian cancer and stage III/IV is compelling, with >85% survival for stage I ovarian cancer, but <20% survival at 5 years for stage III/IV. However, almost 85% of all ovarian cancer patients are diagnosed at stage III/IV (2, 3). With the prevalence of ovarian cancer being only about 1 in 10 000, biomarkers for its early detection must demonstrate specificity >99% at sensitivities >80% (4).
DOI: 10.1373/clinchem.2013.216382
Language: English
Open Access status: green
OpenAlex ID: W2134657394
Cites: 14
Cited by: 6
Related to: 10