Standardization is essential in the clinical lab. But for many labs looking to move to next-generation sequencing (NGS), achieving standardization is elusive. Dr. Harriet Feilotter, Associate Professor of Pathology and Molecular Medicine at Queen’s University in Ontario, Canada, is working to change that.
“Many people assume that once a biomarker is discovered and clinical utility established, that’s the end of the road. That’s not how it works. We need to discuss how to implement these discoveries in the clinical lab,” she says.
She and her colleagues at six other clinical labs in Ontario are executing a ring study to evaluate the reliability and performance of the Ion Torrent™ Oncomine™ Focus Assay* in an effort to establish common protocols and measurements for future clinical use.
“It makes sense to evaluate a NGS assay because there’s a real recognition that doing biomarkers one at a time, in the old standard way, is not the way to go in the future,” Dr. Feilotter says. She wants to know if labs are able to get the same results across multiple sites and multiple operators from a fixed assay.
That’s where the Oncomine products are really useful, she says.
“[Oncomine products] are standardized so that we can develop protocols to share across labs and collectively define a real call. And this is an excellent platform for small samples, from lung biopsies for example. There are many samples we can run that we might not have been able to previously using platforms with larger sample input requirements.”
Making use of the significant platform and analysis pipeline variability across the clinical labs in the study, the team is working to assess the impact of different methodologies (for example, DNA extraction), while at the same time, working to establish standard operating procedures.
Dr. Feilotter hopes the data from the ring study will also be useful for her colleagues working to stratify samples for clinical trial research.
“We can do quite a bit of work that demonstrates the utility of NGS in the lab, but we need this in-between step to better understand how to apply what we are learning,” says Dr. Feilotter.
Dr. Feilotter is passionate about standardization because, she says, she and her clinical lab colleagues are accountable for getting results right. There’s a science to quality control and quality assurance that is often disregarded because it’s not exciting.
“We’ve poured so much money and effort into biomarker discovery and clinical utility. We take that discovery all the way to the clinical lab and then drop it. We do all the work and then we stop one yard short of the goal line. I want to do that last yard.”
In addition to the ring study, Dr. Feilotter is working to build a collaborative network of cancer researchers, pathologists, and oncologists to discuss standardization and NGS using a data-centric approach.
“Any time we can work together, that’s a really good thing. It’s a standardized approach. People want to be in this together,” she says.
Results from the ring study are expected in the next month from the >20 samples including DNA and RNA from a variety of tumor types.
* For Research Use Only. Not for use in diagnostic procedures.