SensiScreen® 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% – 1.0% 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 (upto 5 nG gDNA input)
- 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.
Liquid or FFPE?
The FFPE assays are designed to take larger amounts of gDNA input and can cope with some impurities in the sample. FFPE assays can also be used for FRESH or FRESH FROZEN biopsies. Our Liquid assays can handle up to 5 nG (1,600 copies) DNA input and can normally detect between 1-3 copies of mutated DNA in a background of wildtype cell-free DNA, cfDNA. This makes the assays extremely sensitive and useful for monitoring changes in mutant DNA levels from plasma samples. The input material is normally Plasma that has been prepared no later than 2 hours after the blood sample is drawn (the faster the better), unless drawn in special tubes that stabilizes cell free DNA without destroying the white blood cells in the sample. Needle biopsies and other small biopsies can also be used with the liquid assays.
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
|SensiScreen® Quick Guides:|
|FFPE Ready-to-use||Liquid Ready-to-use|
|FFPE Dispense Ready||Liquid Dispense Ready|
|SensiScreen® Instructional Manual:|
|Instructions and manual for FFPE||Instructions and manual for Liquid|