GenomeWebinars

Recent GenomeWebinars
Tue
May
9
11:00 am2017
Sponsored by
SeraCare

Case Study: Development and Validation of Clinical ctDNA Cancer Assays

GenomeWebinar

 Associate Chair, Surgical Research and Associate Professor of Surgery, Boston University School of Medicine 

This webinar is the last 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.

During this webinar, Tony Godfrey of the Boston University School of Medicine discusses how his lab is developing and validating clinical circulating tumor DNA assays. 

Sponsored by

CEO, Director & Co-Founder,
Clinical Genomics

Associate Director, New Product Quality Assurance,
Qiagen

This online seminar provides an overview of the use of liquid biopsies for cancer recurrence monitoring with a particular focus on colorectal cancer.

Analysis of circulating tumor DNA (ctDNA) has the potential to improve detection and monitoring of cancers in order to significantly impact patient outcomes. This is especially important for cancers with a high rate of recurrence, such as colorectal cancer, where between 30 percent and 40 percent of cases recur. However, the only currently available monitoring blood test misses 74 percent of resectable recurrences.

In this webinar, Dr. Lawrence LaPointe, CEO of Clinical Genomics, discusses how his team is working with Qiagen to develop a ctDNA test for colorectal cancer recurrence monitoring.

Additionally, Dr. Martin Horlitz briefly shares how Qiagen's ctDNA extraction chemistries are compliant with ISO and IVD quality guidelines.

Sponsored by

Former VP, Genomics R&D and Operations, BioReference Laboratories 

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. 

Sponsored by
Thu
Apr
13
11:00 am2017
Sponsored by
SeraCare

Case Study: Development and Validation of a Cancer Hotspot Assay

GenomeWebinar

Dartmouth Hitchcock Medical Center 

This webinar is the second 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, Gregory J. Tsongalis of Dartmouth Hitchcock Medical Center discusses how his lab developed and validated a cancer hotspot assay. 

Sponsored by

Principal, M.D, JD Consulting

Medical Director, Molecular Genetics and Genomics, ARUP Laboratories

Director of Laboratory Science, Palmetto GBA

Our roundtable of industry experts provide an overview of the current regulatory landscape for clinical genomics tests. The panelists discuss how clinical labs can and should ensure the analytical and clinical validity of their tests amid an uncertain regulatory climate. 

*This webinar is part 1 of 4 - Catalyzing Implementation of NGS-based Tests: A Webinar Series 

Sponsored by