This webinar is the third in a four-part series highlighting real-world examples of how some lab directors are bringing validated next-generation sequencing-based tests to the clinic.
If you are a clinical laboratory that is currently running or about to begin offering NGS-based clinical genomics testing and want to know how other labs have addressed specific validation and daily implementation challenges, this webinar series is for you!
Labs looking to implement NGS diagnostics face a number of regulatory challenges. These tests currently fall under the Clinical Laboratory Improvement Amendment guidelines as laboratory developed tests and lack specific validation guidelines and global performance standards. Moreover, these assays feature complex workflows comprised of hardware, wetware, and software from multiple vendors assembled — far different from more standardized approaches that fall under the Food and Drug Administration's guidelines for in vitro diagnostics.
In this webinar, Robert Daber, formerly of BioReference Laboratory, discusses how labs can establish laboratory QC systems to comply with CAP, CLIA, and state regulatory guidelines.