Parafin Blok
Katı biyopsilerde kanser mutasyonu tespiti
SensiScreen®️ FFPE testleri katı biyopsilerde (taze, donmuş veya FFPE doku) veya yüksek miktarda DNA (50 ng’ye kadar) içeren örneklerde genomik DNA’dan somatik mutasyonların saptanması için tasarlanmıştır. Çoğu SensiScreen®️ FFPE testi, 50 ng yabani tip DNA arka planında mutasyona uğramış DNA’nınn% 0.25-1’ini sağlam bir şekilde tespit edebilir.
BRAF V600
SensiScreen® BRAF V600 FFPE testleri, BRAF kodon 600 için 4 mutasyon belirler. BRAF mutasyonlarının tespiti aşağıdaki testleri içerir:
| Assay | Status |
| BRAF V600D/E/K/R Multiplex | CE-IVD |
| BRAF V600D/E/K/R Simplex | CE-IVD |
| BRAF V600E Simplex | CE-IVD |
KRAS Exon 2, 3 and 4
SensiScreen® KRAS FFPE assays identify 23 mutations in KRAS exon 2, 3 and 4.Detection of KRAS mutations by SensiScreen® include the following assays:
| Assay | Status |
| KRAS Exon 2+3+4 Multiplex | CE-IVD |
| KRAS Exon 2 Multiplex G12A/C/D/R/S/V G13D |
CE-IVD |
| KRAS Exon 3 Multiplex Q61H1/H2/E/K/L/R A59G/T |
CE-IVD |
| KRAS Exon 4 Multiplex K117N1/N2 A146P/T/V |
CE-IVD |
| KRAS Exon 2 Simplex G12A/C/D/R/S/V G13D |
CE-IVD |
| KRAS Exon 3 Simplex Q61H1/H2/E/K/L/R A59G/T |
CE-IVD |
| KRAS Exon 4 Simplex K117N1/N2 A146P/T/V |
CE-IVD |
EGFR Exon 18, 19, 20, 21
SensiScreen® EGFR FFPE assays identify 63 mutations in EGFR exon 18, 19, 20 and 21. Detection of EGFR mutations by SensiScreen® include the following assays:
| Assay | Status |
| EGFR Exon 18+19+20+21 | CE-IVD |
| EGFR G719A/C/S | CE-IVD |
| EGFR Exon 19 Deletions (35 deletions) | CE-IVD |
| EGFR S768I | CE-IVD |
| EGFR T790M | CE-IVD |
| EGFR Exon 20 Insertions (22 insertions) | CE-IVD |
| EGFR L858R | CE-IVD |
| EGFR L861Q | CE-IVD |
| EGFR Exon 19 Deletions+T790M+L858R | CE-IVD |
KIT D816V
The SensiScreen® KIT FFPE assay kit identifies the aspartic acid (D) to valine mutation in codon 816 of the KIT gene. Detection of KIT mutations by SensiScreen® FFPE includes the following assay:
| Assay | Status |
| KIT D816V | RUO |
NRAS EXON 2, 3 and 4
SensiScreen® NRAS FFPE assays identify 24 mutations in NRAS exon 2, 3 and 4. Detection of NRAS mutations by SensiScreen® include the following assays:
| Assay | Status |
| NRAS Exon 2+3+4 Multiplex | CE-IVD |
| NRAS Exon 2 Multiplex G12A/C/D/R/S/V G13A/C/D/R/S/V |
CE-IVD |
| NRAS Exon 3 Multiplex Q61H1/H2/K/L/R A59D/T |
CE-IVD |
| NRAS Exon 4 Multiplex K117N1/N2 A146P/T/V |
CE-IVD |
| NRAS Exon 2 Simplex G12A/C/D/R/S/V G13A/C/D/R/S/V |
CE-IVD |
| NRAS Exon 3 Simplex Q61H1/H2/K/L/R A59D/T |
CE-IVD |
| NRAS Exon 4 Simplex K117N1/N2 A146P/T/V |
CE-IVD |
PIK3CA H1047
SensiScreen® PIK3CA H1047 FFPE assay identify three mutations in codon 1047. Detection of PIK3CA mutations by SensiScreen® include the following assays:
| Assay | Status |
| PIK3CA H1047L/R/Y Multiplex | RUO |
| PIK3CA H1047L/R/Y Simplex | RUO |