Proof of concept SAGAsafe® 24-plex ultrasensitive compatibility demonstrated on naica® Prism 6 dPCR instrument

SAGA Diagnostics AB, “SAGA”, a leading cancer liquid biopsy and genomic testing company, adapted a SAGAsafe^® PIK3CA 24-plex mutation detection assay to work on Stilla Technologies’ new naica^® Prism 6 system which was presented at this year’s Annual Meeting of the American Society of Human Genetics (ASHG) on October 14.  Chief Operating Officer Dr. Lao Saal, MD PhD, gave a presentation which was recently covered by GenomeWeb*.

The 24-plex PIK3CA mutation detection assay developed by SAGA Diagnostics is based on SAGA’s patented SAGAsafe^® digital PCR technology. Twenty-four of the most common oncogenic PIK3CA mutations are detected, including the hotspot variants such as E542K, E545K, and H1047R.  The 24-plex SAGAsafe^® assay  was tested on a range of breast cancer patient samples for which next-generation sequencing data was also available and showed excellent concordance (R²=0.992).  Serial dilution experiments also showed excellent and accurate linear quantification to below 0.01% mutant allele frequency (MAF) (R²=0.987 to 0.994).  In analyses of pure wild-type (non-mutant) control DNA, the SAGAsafe^® PIK3CA assay was shown to have a limit of blank (LoB) between 0.001% to 0.003% MAF and a limit of detection (LoD) between 0.002% to 0.009 MAF, depending on the mutation and fluorescence channel.

The SAGAsafe^® digital PCR technology has in the past also been shown to be compatible with the Bio-Rad, Qiagen, and Combinati/ThermoFisher instruments.  The SAGAsafe^® 24-plex PIK3CA was adapted by SAGA Diagnostics as part of this collaboration to show the compatibility of the SAGAsafe^® technology with the naica^® Prism 6 instrument.