About the Series
GenomeWeb has partnered with SeraCare to produce a series of online seminars highlighting best practices for validating clinical genomics tests.
The emergence of next generation sequencing-based genomic testing in the clinic has rapidly changed the diagnosis and management of cancer, prenatal care, and inherited diseases. However, labs looking to implement these novel diagnostics face a number of regulatory challenges. NGS tests currently fall under the Clinical Laboratory Improvement Amendment guidelines as laboratory developed tests and lack specific validation guidelines and global performance standards.
This four-part webinar series highlights the need for improved performance and global standardization in the implementation of these assays and will offer real-world examples of how some lab directors are bringing validated tests to the clinic.
The webinar series kicked off with a roundtable of expert panelists who provided an overview of the current regulatory landscape for clinical genomics tests.
Next in the webinar series are three case studies that focus on the development and validation of specific clinical genomic tests.
March 30, 2017 | 11:00 AM ET
The series kicked off with this roundtable of expert panelists that provide an overview of the current regulatory landscape for laboratory-developed tests, particularly in light of the FDA's recent decision to delay finalizing its proposed guidance on the issue. Our panelists discuss how clinical genomics labs can and should ensure the analytical and clinical validity of their tests amid an uncertain regulatory climate.
April 13, 2017 | 11:00 AM ET
In this webinar, Gregory J. Tsongalis of Dartmouth Hitchcock Medical Center discusses how his lab developed and validated a cancer hotspot assay.
April 27, 2017 | 11:00 AM ET
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.
May 9, 2017 | 11:00 AM ET
In this webinar, Tony Godfrey of the Boston University School of Medicine discusses how his lab is developing and validating clinical circulating tumor DNA assays.