SafeSEQ technology overview

Ultra-sensitive next-generation sequencing for the reliable detection of rare mutant molecules through optimized technology and panel design

The right solution for the right question

Next-generation sequencing is a balancing act between sensitivity, genomic coverage, and cost.  

“Pan-cancer” and “universal” NGS tests sacrifice sensitivity and cost in favor of broad coverage and are not able to meet the needs of a wide range of applications.

Therefore, Sysmex Inostics has developed SafeSEQ, a highly sensitive, customizable NGS solution for precision oncology:

  • SafeSEQ achieves high sensitivity and quantitative mutation calling by focusing on the most clinically relevant regions for different cancer types.
  • This also ensures minimal cost since excess data are not produced and wasted with every run as for large panels.
  • Rapid custom panels allow true optimization of the diagnostic test to fit the clinical need.

Additional benefits

  • Proven Safe-SEQ technology combined with proprietary bioinformatic analysis to maximize analytic performance.
  • Compatible with both tissue specimens and plasma ctDNA → decreased variability when analyzing matched specimens.
  • Built on Sysmex’s vast experience with plasma ctDNA analysis using our gold-standard OncoBEAM™ technology.

The importance of dynamic NGS tests

For NGS-based testing, real-world limitations mean there is little flexibility around sample input DNA amount and cost. As a result, a trade-off exists between sensitivity and genomic coverage.

Coverage across a large area is possible at relatively low sensitivity, or high sensitivity can be achieved for focused coverage of a few targets.  If both high sensitivity and comprehensive coverage are required, sample input and cost are increased.

Tumor monitoring

A novel application with unique needs

The emerging utility of tracking tumor-specific genetic alterations for molecular monitoring of disease status in real time highlights the need for flexible tests.

Discovery of cancer-relevant mutations via tissue sequencing requires an assay that interrogates the most relevant set of targets for a particular type of cancer.  After somatic mutations have been characterized in the tissue, tracking via ctDNA analysis of serial blood draws requires extremely high sensitivity, and high resolution detection of the selected markers.

An NGS test used for disease monitoring must be able to modulate the balance between sensitivity and genomic coverage to ensure robustness for both discovery as well as tracking of mutations.  Through unique design and customization, SafeSEQ is able to fulfill these requirements.

SafeSEQ is a low error rate ("safe") sequencing technology

  • Assignment of a unique identifier (UID) to each DNA molecule to be analyzed
  • Amplification and deep sequencing of universally tagged DNA molecules (UID families)

This allows for differentiation between real mutations and errors introduced during the amplification and sequencing process.