Dispense Ready (DR) and Ready-to-Use (RTU)

DR version contains 20 reactions and RTU version contains 12 reactions

SensiScreen^® Liquid EGFR qPCR Assay targets one or more mutations in exon 18, 19, 20 and 21 of the human Epidermal Growth Factor Receptor (EGFR) gene.

Genomic targets:

EGFR Exon 18+19+20+21 Multiplex (E1 )
EGFR G719 Multiplex (E2)
EGFR G719 Simplex (E3)
EGFR Exon 19 Deletions (E4)
EGFR S768I (E5)
EGFR T790M (E6)
EGFR Exon 20 Insertions (E7)
EGFR L858R (E8)
EGFR L861Q (E9)
EGFR Exon 19 Deletions; T790M; L858R (E10)

SensiScreen^® Liquid EGFR qPCR Assay                        Reference number                        Reference number
                                                                                            Dispense Ready (DR)                    Ready-To-Use (RTU)
                                                                                            20 reactions                                   12 reactions

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EGFR Exon 18+19+20+21 Multiplex (E1)                      5675                                                5686

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EGFR G719 Multiplex (E2)                                               5550                                                5366

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EGFR G719 Simplex (E3)                                                 5575                                                5391

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EGFR Exon 19 Deletions (E4)                                          5545                                                5361

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EGFR S768I (E5)                                                                5555                                               5371

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 EGFR T790M (E6)                                                            5540                                                5351

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EGFR Exon 20 Insertions (E7)                                         5570                                               5386

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EGFR L858R (E8)                                                               5560                                               5376

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EGFR L861Q (E9)                                                              5565                                                5381

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EGFR Exon 19 Deletions; T790M; L858R (E10)            3075                                                5408

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SensiScreen^® Liquid EGFR qPCR Assay is an In vitro Diagnostic Assay for Sensitive Detection, Identification and Quantification of the EGFR Mutational Status.

SensiScreen^® Liquid EGFR Assay product variants include the complete range of targeted EGFR mutations (product variant E1) or target specific EGFR gene mutations including G719X simplex and multiplex (product variants E2+E3), exon 19 deletions (product variant E4), S768I (product variant E5), T790M (product variant E6), exon 20 insertions (product variant E7), L858R (product variant E8), L861Q (product variant E9) and exon 19 deletions+T790M+L858R (product variant E10).

Each product variant is supplied as both a Dispense Ready (DR) and a Ready-to-Use (RTU) version. DR assays include oligonucleotide mixtures and Master Mix in separate tubes which need to be dispensed into suitable plasticware before addition of template. RTU assays are pre-dispensed in PCR strip tubes and only need the addition of template before real-time qPCR amplification.

SensiScreen^® Liquid EGFR qPCR Assay combines allele-specific PCR with PentaBase’s novel and selective technologies comprising both HydrolEasy^® probes, SuPrimers™ and BaseBlockers™ for specific and sensitive target amplification. The SensiScreen^® Liquid EGFR qPCR Assay is based on PentaBase’s unique intercalating nucleic acid (INA^®) technology and the inclusion of intercalating pseudonucleotides (IPNs), which are synthetic DNA analogues comprising a flat heteroaromatic, hydrophobic molecule and a linker. IPN molecules are inserted into the oligonucleotides at fixed positions during oligonucleotide synthesis. The SensiScreen^® Liquid EGFR qPCR Assay contains both standard and INA^® oligonucleotides.

Intended purpose:
SensiScreen^® Liquid EGFR qPCR Assay is a semi-quantitative real-time Polymerase Chain Reaction (PCR) assay intended for the relative quantification of specific somatic mutations in the human Epidermal Growth Factor Receptor (EGFR) gene in cell-free DNA (cfDNA) purified from liquid biopsies including plasma and serum. The assay is used with semi-automated real-time PCR systems and samples can be prepared using automated platforms or in manual workflows. The assay is an in vitro diagnostic medical device intended for patients already diagnosed with EGFR mutation to aid in disease monitoring based on EGFR mutation status. The test result correlates with the amount of EGFR mutant cfDNA. Results can be used to determine changes in EGFR mutation quantity levels in patients over time such as during cancer interventions or during follow-up. It is not intended as a companion diagnostic device.

Intended user:
SensiScreen^® Liquid EGFR qPCR Assay is intended to be used by healthcare professionals or qualified laboratory personnel instructed and trained in the techniques of real-time PCR as well as proficient in handling biological samples. Medical interventions based on results from this product require medical authorization.

Procedure                                                                 Designed to run on open platforms with at least
                                                                                    two-channels (green and yellow).

Validated Real-Time PCR instruments                 MyGo Pro (IT-IS Life Science) and ABI 7500 real-time PCR
                                                                                    instruments

PentaBase technologies                                        Based on our INA^® technology. The mutation-specific
                                                                                    assay contains a HydrolEasy^® probe, a BaseBlocker™, a
                                                                                    mutation-specific primer set and an internal control
                                                                                    assay

Genomic target                                                        Exons 18, 19, 20 and 21 of the human EGFR gene

Sample types                                                            Liquid

Sample DNA extraction methods                         cfDNA extraction kits and/or procedures specially
                                                                                    designed for handling of liquid biopsy samples
                                                                                    according to the manufacturer´s instructions

Sample input                                                            5 ng DNA or less per reaction

PCR run time                                                            Less than 2 hours

The latest version of the Instructions For Use (IFU) can be found at: https://5ba.se/SS004

Jensen et al. – PLoS One – 2021 – Click here for article