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- Title
Predictive Markers Require Thorough Analytic Validation.
- Authors
Troxell, Megan L.; Fulton, Regan S.; Swanson, Paul E.; Bellizzi, Andrew M.; Fitzgibbons, Patrick L.; Ambaye, Abiy B.; Haas, Thomas S.; Goldsmith, Jeffrey D.; Loykasek, Patti A.; Miller, Dylan V.; O'Malley, Dennis; Jingxin Qiu; Salama, Mohamed E.; Schaberg, Kurt B.; Schwartz, Robert A.; Jinru Shia; Summers Jr., Thomas A.; Yaping Wu; Thunnissen, Erik
- Abstract
The author conveys his response to a feedback about his editorial on the difference between analytical/technical validation of a diagnostic test and clinical validation of a predictive test in pathology. Topics mentioned include how to perform analytical validation in a diagnostic context, placenta as intended positive control in at least one assay approved by the U.S. Food and Drug Administration, and threshold setting in predictive testing needed for clinical validation.
- Subjects
LUNG cancer diagnosis; THERAPEUTIC use of monoclonal antibodies; ANTIGENS; GENE expression; IMMUNOHISTOCHEMISTRY; LUNG cancer; STAINS &; staining (Microscopy); TUMOR markers; UNITED States. Food &; Drug Administration; DRUG approval; PREDICTIVE tests
- Publication
Archives of Pathology & Laboratory Medicine, 2019, Vol 143, Issue 8, p907
- ISSN
0003-9985
- Publication type
Article
- DOI
10.5858/arpa.2019-0112-LE