The AuraSeq test family is compatible with formalin-fixed, paraffin embedded (FFPE) tissue samples, which is the most common pathology specimen type, as well as cytology smears2-4. These NGS-based clinical tests require minimal nucleic acid input (1 to 10 ng total of DNA or RNA), which is advantageous when testing very small, diagnostic samples.
When implementing NGS-based testing in clinical laboratories, the analytical and clinical validation of both the wet bench assay and dry bioinformatics pipelines are crucial. Such validation of the detection of somatic variants must assess limit of detection, analytical sensitivity and specificity, repeatability and reproducibility and set appropriate thresholds and quality control parameters5 for reliable analysis of clinical specimens. Validation must also include the handling of large amounts of data produced by multi-gene panels, and be able to produce easy to interpret clinical reports for the treating physician.
The intended use of the AuraSeq tests is to detect somatic variants in multiple cancer driver genes using NGS technology in advanced carcinoma samples from patients who have failed to respond to conventional chemotherapy or are about to start a TKI regime.
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