Step 1: Sample Preparation

DNA SEQ uses full-service Next Generation Sequencing (NGS) service providers that are both CLIA certified and GLP compliant. In addition, our NGS providers use best practices automated sample preparation, eliminating variability from chemistry and manual steps to ensure the highest quality results.

Sequencing reactions are quite precise; minute variations in reagent volumes, flow, and temperature that can lead to base substitution errors or an incomplete sequence extension. Low quality chemistry and sample handling during sample preparation is a major source of error; precision liquid handling with automated sample prep improves the accuracy of passive and active chemistry steps within the sample-prep workflow. In addition to reducing the possibility of human error with manual processes, automated sample preparation also results in additional savings on reagent costs as well as accelerating sample processing turnaround time. Automation enables sample-prep runs to happen overnight. DNA can be ready for sequencing in the morning.

As NGS becomes more routine in clinical medicine, relying on manually documenting manual steps is increasingly impractical. NGS technologies hold tremendous promise for advancing diagnostics and making therapeutic decisions. However clear guidelines are needed for quality control procedures, reporting results to patients, assay validation, proficiency testing, and certifying reagents.

An additional advantage of automated sample prep systems is sample-tracking software that fulfills the requirement to demonstrate secure sample handling. The tracking software documents the chain of custody as patient samples are transported to thelaboratory and through the assay workflow. These audit trails satisfy documentation requirements for quality checks and ensures that patient confidentiality controls are in place.

In the next three years, the number of next-generation sequencing (NGS) samples processed will more than double. DNA-SEQ will continue to stay at the forefront of NGS best practices protocols. Target enrichment, library preparation, and library amplification are the key steps that are particularly susceptible to introducing bias. Therefore automated sample preparation is essential to ensure accurate sequencing results.

However, automated sample preparation does not eliminate the critical role of the pathologist in selection of the sample for automated preparation. The pathologist’s role is critical because tumor samples often contain cells other than the cancer cells. In most cases extraction of pure cancer cells is critical to enrich the sample of the relevant DNA material. At DNA SEQ, we pay particular attention to the central role of the pathologist in both the preparation process and in quality control of our preparatory step.