Close Menu

Catalyzing Implementation of NGS-based Tests: A Webinar Series

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

Roundtable Discussion: Best Practices for Validation, Monitoring, and Controls

View Recording

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

Case Study 1: Development and Validation of a Cancer Hotspot Assay

View Recording

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

Case Study 2: QC Systems to Comply with CAP, CLIA, & State Regulatory Guidelines

View Recording

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

Case Study 3: Development and Validation of Clinical ctDNA Cancer Assays

View Recording

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.

Gene editing could be an issue competitive sports need to address soon, four researchers from Arizona State University write at Slate.

A genetic alteration appears to increase heart failure risk among people of African descent, according to the Washington Post.

In his look back at the past decade, BuzzFeed News' Peter Aldhous writes that direct-to-consumer genetic testing has led to "Facebook for genes."

In Nature this week: genetic "clock" that can predict the lifespans of vertebrates, new assembler called wtdbg2, and more.