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, typically between 0.1% – 0.5% of mutant DNA in a wild type background
- Hands-on-time 1-4 minutes per sample
- Time to answer < 1½ hours
The reason that SensiScreen® assays are more sensitive and robust than other real-time PCR based assay, is due to the fact that the assays comprise our proprietary SuPrimer™ and BaseBlocker™ technologies (follow links to read more about these technologies). The SuPrimer™ and BaseBlocker™ technologies reduce the false negative and false positive signals significantly and ensure the highest sensitivity, robustness and user friendliness of the SensiScreen® assays.
As all our SensiScreen® CE IVD assays are running under the same conditions and settings, they can be mixed and matched in a variety of combinations to accomodate for an efficient and flexible workflow in the clinical laboratories. There are numerous ways the assays can be combined so please inquire if you are interested in other combinations than the ones listed in the shop.
Multiplex or Simplex?
All our assays are developed in two versions: A multiplex version for detecting the presence of a group of somatic mutations, requiring very little sample DNA. Secondly, a Simplex version genotyping the mutation and having highest possible sensitivity for monitoring purposes is also available. Both types of assay run under the same conditions and settings.
Click on thumb nail below, to see one example of a suggested workflow for colorectal cancer (CRC) samples, minimizing the amount of assays needed to be done, in order to stratify the CRC patients.
Ready-to-use or Dispense ready?
SensiScreen® assays comes in two different layouts please see figure below:
SensiScreen® CE IVD assays have been clinically validated in Denmark and Switzerland. Furthermore, SensiScreen® KRAS EXON2 and BRAF CE IVD assays have been compared to several common methods for somatic mutation testing. In all cases, SensiScreen® assays were found to find more true positive patients than the competition.
All SensiScreen® assays have been CE IVD certified in compliance with the requirements of DIRECTIVE 98/79/EC, on in vitro diagnostics. Free sales certificate