MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
XL EGFR amp
Amplification Probe
- Order Number
- D-6005-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 077
- Regulatory Status
- IVDD
IVDR Certification
MetaSystems Probes has already certified a large part of its portfolio, according to IVDR. For organizational reasons, we currently provide only the IVDD product.
Discover all IVDR-certified productsXL EGFR amp consists of an orange-labeled probe hybridizing to the EGFR gene region at 7p11.2 and a green-labeled probe hybridizing to the centromere of chromosome 7.
Probe maps are created in accordance with the intended purpose of the product. Solid colored bars do not necessarily indicate that the probe fully covers the indicated genomic region. Therefore, caution is advised when interpreting results generated through off-label use. Probe map details based on UCSC Genome Browser GRCh37/hg19. Map components not to scale. Further information is available on request.
EGFR (epidermal growth factor receptor) gene amplification generally results in increased protein expression in breast carcinomas. About 6% of breast carcinomas show moderate to low-level EGFR amplification associated with genuine EGFR protein overexpression. Studies in non-small cell lung cancer (NSCLC) have shown that EGFR expression is associated with reduced survival, frequent lymph node metastasis, and poor chemosensitivity.
EGFR is a member of the ErbB family of receptors, a subfamily of four closely related receptor tyrosine kinases which all play an important role in controlling normal cell growth, apoptosis, and other cellular functions. Mutations of EGFRs can lead to NSCLC, pancreatic cancer, breast cancer, colon cancer, and some other cancers.
New drugs such as gefitinib and erlotinib directly target the EGFR. EGFR-positive patients have shown a 60% response rate, which exceeds the response rate for conventional chemotherapy.
Clinical Applications
- Solid Tumors (Solid Tumors)
Normal Cell:
Two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
Two green (2G) and one separate orange (1O) signal, and orange signal clusters indicating amplification of EGFR (homogeneously staining region =HSR).
Aberrant Cell (typical results):
Two green (2G) and multiple copies of orange signals indicating amplification of EGFR (double minute=dm).
- Okada et al (2003) Cancer Res 63:413-416
- Bhargava et al (2006) Mod Patho 18:1027-1033
- Sholl et al (2009) Cancer Res 69:8341-8348
Certificate of Analysis (CoA)
or go to CoA DatabaseIVDR Certification
MetaSystems Probes has received IVDR certification for our initial 26 fluorescence in situ hybridization (FISH) probes from the notified body, BSI. Achieving this milestone was not without its challenges, and we are delighted to have accomplished IVDR certification for this probe set at an early stage.