Recently, Thermo Fisher Scientific sat down with Carolina Felix, Senior Biomedical Scientist at the Liverpool Clinical Laboratories (LCL) Molecular Pathology Service, to learn about her lab’s experience working with Thermo Fisher’s Service and Support team for a research assay validation consultation.
Carolina Felix
Senior Biomedical Scientist
Liverpool Clinical Laboratories
Established in 2013, LCL is the largest, multidisciplinary pathology service provider in the Liverpool area of the United Kingdom, with more than 500 trained consultants, scientists, and medical laboratory assistants. The Molecular Pathology Service provides immunocytochemistry and genomic testing services to hospitals in the area.
Q. Can you tell us about your previous workflow prior to implementing the Oncomine Precision Assay (OPA) on the Genexus System?
A. The Molecular Pathology Service at LCL has been providing a regional service in Cheshire & Merseyside for over 10 years. Originally, our lab was performing single gene molecular profiling of EGFR variants, ALK and ROS1 gene fusions and PD-L1 protein expression. This required the use of a combination of multiple techniques, including RT-PCR, IHC and FISH. We currently examine approximately 1200 NSCLC samples per year and, with the increase in molecular biomarkers, we decided to explore the possibility of implementing local NGS.
Q. What challenges do you usually face with a new assay analytical validation?
A. LCL is based in a large teaching hospital and referral centre for other laboratories. With this comes a fair amount of projects and we have been involved in a number of these, including for IHC, FISH, RT-PCR, etc. The time it takes to complete a validation can be dependent on several factors. The availability of staff to undertake testing activities whilst delivering other commitments, and access to a dynamic range of material to include in testing are factors. Validation costs vary but include the cost of reagents, scientific/consultant staff time, and the cost of commercial control material.
Q. How did Thermo Fisher’s AV consulting service help you to address these challenges?
A. Working with the AV team helped with project planning, run planning, and the analysis of results. This reduced the burden on the scientific staff involved in the project and allowed us to perform project work alongside our daily activities. The AV consultation package is also cost-effective as it includes all reagents, commercial control material, and the consulting services of the AV team.
Q. How was the support you received from Thermo Fisher?
A. The support we received from the Thermo Fisher AV team was excellent. The run plans provided were clear and simple to follow. The weekly project meetings were very friendly, and the results/progress were all clearly explained. The Customer Concierge team were also very helpful with documentation and the delivery of reagents and controls.
Q. What were your experiences with analyzing and understanding the NGS data generated as part of the project?
A. As we had used Genexus and OPA before, it was not the first time we had seen results from the assay. However, the number of runs and samples included in the project generated a considerable amount of data. The AV consultation service assisted significantly in the analysis of the run data, comparing against expected results and provided detailed updates.
Q. What were the key takeaways and learnings for your next validation?
A. We would advise to take some time to select the samples you wish to include in your project. We were fortunate that we had a large number of samples previously tested by NGS and so had access to a wide range to choose from, which included some rare variants, rare fusions, and CNVs.
Q. Would you recommend this consulting service to new NGS users looking to implement and analytically validate a new assay?
A. We would certainly recommend the AV consulting service to labs looking to introduce NGS. It can save you time completing your validation and it is cost effective with regards to the reagents, commercial controls and the service included.
Thermo Fisher Scientific’s analytical validation consulting service helps research labs achieve validation up to 62% faster than the average in-house AV (based on internal data). With solutions to fit any need and budget across the globe, our AV consultants assist with RUO assay validation. Our aim is to help our customers shorten validation time and control cost.
Our AV services are just one piece of the puzzle, however. Thermo Fisher’s comprehensive Service and Support offerings help ensure that there is a solution for every lab’s need – whether you are a new customer just getting started or an established NGS user looking to troubleshoot or add a new assay to your workflow.
Learn more about service and support options for Oncomine Solutions users at oncomine.com/support
*Analytical validation services from Thermo Fisher Scientific are offered in support of research efforts only.
Recently, Thermo Fisher Scientific sat down with Carolina Felix, Senior Biomedical Scientist at the Liverpool Clinical Laboratories (LCL) Molecular Pathology Service, to learn about her lab’s experience working with Thermo Fisher’s Service and...
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