SeraCare Life Sciences, in partnership with GenomeWeb, recently offered this exciting on-demand webinar: A Practical Guide to Clinical Genomics Assay Validation. Watch this webinar to learn specific ways you can save time and money while thoroughly validating an NGS-based clinical genomics assay, validation best practices, and how to navigate the many guidelines and requirements of the various authoritative bodies for clinical genomics testing.
During the Q&A portion of the webinar, the following question was posed:
Can you comment on the extent to which iQ NGS features and capabilities are part of commercially available LIMS and other software solutions?Lorn Davis, Sr. Director Data Operations answers:
iQ NGS is a full-process QC management software allowing labs to track the QC metrics of reference materials from sample and library prep through sequencing, and through the bioinformatics pipeline to the final variant calls. Similar to a LIMS, metrics can be created for runs and samples with defined pass/warn/fail thresholds for automatic assessment as well as offering the ability to track critical run metadata such as instruments, analyses, operators, and lots to ensure traceability of data. This data along with the digital review functionality is used to generate and run QC reports that can be used to demonstrate compliance in inspections and audits.
Also, like LIMS and other software products, iQ NGS offers multiple options to enter data into the system including manual entry, automated run creation from files using a client application, and full integration using the REST API. The latter two options make it practical for iQ NGS to interact with LIMS and the bioinformatics pipeline and avoid duplicative manual entry of data.
iQ NGS differs from LIMS by exclusively focusing on QC metrics from reference materials (no other specimens or patient samples) and extending to tracking variant calls for the known variants in the reference material along with other bioinformatics QC metrics. Using this data, the software will offer analysis of those metrics to help answer key questions of imprecision and degradation trend identification, operator and instrument equivalency, and opt-in inter-site performance benchmarking. This level of analysis is currently unmet by other software in the marketplace and is founded upon the understanding and integration with our Seraseq reference materials and our iQ NGS Confidence Score that offers a single quantitative assessment of the performance of all the variants in a run. The combination of the iQ NGS software with our Seraseq reference materials offers a clear path for labs to standardize their performance intra-lab and inter-lab.
Are you looking for clarity on validation guidance?
Our new eBook offers insights for more effective and less costly assay management and will walk you through key considerations and guidelines that will ensure a smooth and successful validation.
"Nothing is more frustrating than finding a sample that is positive for a relevant variant but cannot be tested multiple times due to sample depletion."