As the use of genetically targeted cancer therapies becomes mainstream, the demand for reliable NGS assays is skyrocketing. To help doctors personalize treatments to their patients genetic profiles and to stand out from the competition clinical laboratories like yours are constantly looking for ways to create more accurate, more comprehensive assays.
We call this the quest for the elusive bulletproof assay one that exhibits the highest performance and reliability in delivering patient results. Because NGS assays are so complex, involving a dizzying number of genes, mutation types, and options for sequencing and bioinformatics, the bulletproof assay is no easy feat. But it can be done.
As we wrote in our last blog post, there are three key steps:
- Consulting with experts
- Outlining your validation and quality control (QC) strategies together
- Evaluate reference material options
In this article, well discuss step two: strategically outlining the NGS assay validation study and QC plan together.
Doing the validation study and QC plan at the same time will give your lab the highest probability of achieving a functioning assay with high quality: