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

LUND, Sweden — /October 20, 2021/ — 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.


We’ve experimentally verified that the SAGAsafe® assay technology is compatible with dPCR instruments from all the major manufacturers including Bio-Rad, Qiagen, and Combinati/ThermoFisher, and now have shown this is also true on the naica® Prism 6-color platform. For liquid biopsy diagnostics to become routine in the clinics, they need to be fit for purpose and cost-effective.  Digital PCR-based clinical assays, now that we can achieve excellent sensitivities even in a complex multiplex format using SAGAsafe®, hit the sweet spot for breadth, turn-around-time, and cost.  By showing that our multiplex assays work on yet another dPCR system, we have come a step further to our goal of making our technology available for as many cancer patients as possible.
Lao Saal, COO and co-founder of SAGA Diagnostics


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.

* Read the coverage on GenomeWeb.




CEO Peter Collins  [email protected]  Phone: +46 (0) 733 01 7242


Richard Hayhurst/Ola Björkman  [email protected]  Phone: +44 (0) 7711 821527


About SAGA Diagnostics AB
SAGA Diagnostics is a personalized cancer genomics and disease monitoring company that offers molecular genetic testing of tissue biopsies and non-invasive “liquid biopsies” such as blood samples. SAGA helps pharmaceutical companies, scientists, and healthcare providers to detect actionable mutations, stratify patient groups, and monitor treatment response more accurately and to an industry-leading lower limit of detection of 0.001%. Analysis of circulating tumor DNA using these proprietary technologies gives SAGA unique ultrasensitivity, and provides the basis for optimal decision-making.

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