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

DR version contains 20 reactions and RTU version contains 12 reactions

SensiScreen^® FFPE 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: (Variant number)??????????????

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^® FFPE 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)                      5670                                                5681

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EGFR G719 Multiplex (E2)                                               2085                                                2081

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EGFR G719 Simplex (E3)                                                 3027                                                3071

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EGFR Exon 19 Deletions (E4)                                          2075                                                2071

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EGFR S768I (E5)                                                                2095                                               5681

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 EGFR T790M (E6)                                                            2065                                                2061

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EGFR Exon 20 Insertions (E7)                                         3025                                               3021

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EGFR L858R (E8)                                                               3005                                               3001

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EGFR L861Q (E9)                                                              3015                                                3011

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EGFR Exon 19 Deletions; T790M; L858R (E10)            3077                                                5398

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

SensiScreen^® FFPE 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 in addition supplied as a Dispense Ready (DR) version 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^® FFPE 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^® FFPE 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^® FFPE EGFR qPCR Assay contains both standard and INA^® oligonucleotides .

Intended purpose:
SensiScreen^® FFPE EGFR qPCR Assay is a semi-quantitative real-time Polymerase Chain Reaction (PCR) assay intended for the semi-quantitative detection of specific somatic Epidermal Growth Factor Receptor (EGFR) gene mutations in human DNA purified from solid biopsies such as Formalin-Fixed Paraffin-Embedded (FFPE) tissue. The assay is used with real-time PCR systems and samples can be prepared using automated platforms or in manual workflows. SensiScreen^® FFPE EGFR qPCR Assay is an in vitro diagnostic medical device intended to detect, identify, and quantify the EGFR somatic mutational status for stratification . It is not intended as a companion diagnostic device.

Intended user:
SensiScreen^® FFPE EGFR qPCR Assay is intended for use 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 authorisation.

Procedure                                                                 Real-time PCR – Designed to run on open platforms with a
                                                                                    minimum of two-channels (green and yellow)

Validated Real-Time PCR instruments                 BaseTyper™ 48.4 (PentaBase), MyGo Pro (IT-IS Life
                                                                                    Science) and CFX96 (Bio-Rad)

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                                                           Solid biopsies (FFPE)

Sample tumor cell percentage                              At least 20%

Sample DNA extraction methods                         Relevant commercially avaliable solid biospy/FFPE DNA
                                                                                    extraction kits

Sample input                                                            5-50 ng of DNA per reaction (1-10 ng/µL)

PCR run time                                                            Less than 2 hours

The latest version of the Instructions For Use (IFU) can be found at: https://5ba.se/SS003