DATE: January 23, 2018
TIME: 12:00 PM PST, 3:00 PM EST

The translation of basic scientific research to clinical application in the hospital or clinic setting is vital for advancing the quality of patient care. This is particularly true in the clinical laboratory when hospital labs evaluate new biomarkers for potential clinical use as a laboratory developed test (LDT).

The numerous steps taken to evaluate the analytical and clinical performance of each novel biomarker are critical to this process before the test can be ordered. These steps ensure the test results are accurate and reproducible when performed by laboratory technologists and confirm that results can be used to improve disease diagnostics or prognostics.

Here we will describe the process a major academic medical center takes to critically evaluate novel biomarkers for various clinical applications and provide examples of such novel biomarkers that are either under evaluation or have been recently completed.

Learning Objectives:

• Understand what factors are important to consider when deciding which novel biomarker to evaluate for clinical use
• Understand the importance and challenges of analytical validations of assays for novel biomarkers
• Understand the importance and challenges of clinical validations of assays for novel biomarkers