GENE AMPLIFICATIONS
REMBRANDT® HER2 amplification detection
| Technology | FISH | ISH |
| Area of interest | Formalin-fixed paraffin-embedded tissue sections or fixed cytological specimen | Formalin-fixed paraffin-embedded tissue sections or fixed cytological specimen |
| Region | 17p11.1-q11.1 | 17p11.1-q11.1 |
| 17q12 | 17q12 | |
| Detection | ♦ (AF488, 2000) and ♦(AF555, 3000) | Biotin (0100) or Digoxigenin (9900) |
| Product No. | C801K.5206 (20T) or C801K.5206.05 or C801K.5206.10 | C801K.0199.05 or C801K.0199.10 |
| Product Type | In vitro diagnostics (IVD) or Research use only (RUO) | Research use only (RUO) |
| Intended Use | The REMBRANDT® HER2 amplification FISH detection assay is intended for the detection of amplifications of the Her2-neu gene (17q12 locus) compared to the chromosome 17 copy number status by means of fluorescence in situ hybridization in breast cancer patients. | The REMBRANDT® LSI17q12/CEP17 ISH detection assay is intended for the detection of copy numbers of the Her2-neu gene (17q12 locus) compared to the chromosome 17 copy number status by means of in situ hybridization. |
| Kit contents | C801P.5206 LSI 17q12/CEP17 FISH probe mix | C801P.0199.05 or C801P.0199.10 LSI 17q12/CEP17 ISH probe mix |
| R018R.0000 Pepsin diluent | R018R.0000 Pepsin diluent | |
| R011R.0000 Pepsin powder | R011R.0000 Pepsin powder | |
| R025R.0000 PanWash 4, 25x SSC | R025R.0000 PanWash 4, 25x SSC | |
| R026R.0000 Pre-treatment buffer | R026R.0000 Pre-treatment buffer | |
| Z000R.0050 Fluorescent mounting medium | ||
All products are also available as stand-alone RUO products