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SensiScreen®

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

Differentiating Technologies

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.

Workflow

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.

workflow_generelt Both manual and automated DNA extraction protocols can be used for the input DNA. PentaBase recommend using Maxwell® RSC Instrument in combination with SensiScreen®. Promegas Maxwell® RSC Instrument is designed to be extremely reliable and consistently produce high-quality nucleic acids.

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.

Suggested Workflow

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.

Workflow Sensiscreen2

Ready-to-use or Dispense ready?

SensiScreen® assays comes in two different layouts please see figure below:

Product Picture

SensiScreen® Ready-to-use CE IVD. All reagents are pre-dispensed into PCR strips.  Simply add 5.0 µL extracted patient DNA to each vial in the supplied strip and analyse in one of the supported real-time PCR systems of your choice. The picture to the left illustrates how a Ready-to-use strip could look like. One strip is used per reaction.

DSC_3049 (2) 324x324

SensiScreen® Dispense Ready CE IVD. All reagents are included in separate vials. This allow the assay to be shipped on blue ice. Simply add 7.5 µL primer-probe mix, 12.5 µL mastermix and 5.0 µL extracted patient DNA to individual wells in your plasticware and analyse in one of the supported real-time PCR systems of your choice. The picture to the left illustrates how a dispense Ready assay is shipped. The individual vials comprise reagents for several reactions of a given test.

Clinically validated

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.

Documentations

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

Downloads:

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
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