December 2019 – Published in the peer-reviewed journal, Obstetrics & Gynecology, the authors explain the importance of following best practices for development of omics tests, as formatted into guidelines by the National Academy of Medicine’s Committee on the Review of Omics-based tests in 2012. Noting that when assessing any predictive test’s performance, all patients for whom the test will be applicable clinically (also known as the intended-use population), must be evaluated in order to determine valid predictions that providers can use to improve care delivery.
The paper identifies published examples of biomarker research that reports falsely elevated performance through selective omission of subsets of patients from the data analysis. Such predictions are actually mis-calibrated—over- or under-calling the actual risks of premature delivery. Mis-calibration could result in suboptimal treatment decisions for the patients tested, and have potentially serious regulatory consequences.
Gapped analyses may be appropriate as proof of concept or for preliminary evidence to support further research, but such reports cannot imply clinical test performance nor be described as “clinical validation.”