CE IVD Cancer Companion Diagnostics
SensiScreen® CE IVD are real-time PCR based assays for somatic mutation detection in cancer patients. SensiScreen® assays combine ultra high sensitivity with multiplexing capabilities, speed, ease-of-use and little hands-on-time. Important features of SensiScreen® assays are the implementation of PentaBase’s proprietary DNA analogue platform technology and the inclusion of baseblockers that make SensiScreen® assays superior to most current somatic mutation tests with regard to sensitivity and specificity.
Limit of detection, LOD, of FFPE assays 0.25% – 1.5% of mutant DNA in a wild type background (5 to 50 nG gDNA input)
LOD of liquid assays down to one copy of mutated DNA (up to 5 nG gDNA input)
Hands-on-time 1-4 minutes per sample
Time to answer < 1½ hours