MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
XL MYC amp
Amplification Probe
- Order Number
- D-6008-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 088
- 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 MYC amp consists of an orange-labeled probe hybridizing to the MYC gene region at 8q24.21 and a green-labeled probe hybridizing to the centromere of chromosome 8.
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.
Amplification of MYC has been described in many types of tumor, including breast, cervical and colon cancers, as well as in squamous cell carcinomas of the head and neck, myeloma, non-Hodgkin lymphoma, gastric adenocarcinomas and ovarian cancer. MYC is the most frequently amplified oncogene and the elevated expression of its gene product correlates with tumor aggression and poor clinical outcome.
The proto-oncogene MYC, located at 8q24.1, encodes a nuclear phosphoprotein transcription factor which has an integral role in a variety of cellular processes, such as cell cycle progression, proliferation, metabolism, adhesion, differentiation, and apoptosis.
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 MYC (homogeneously staining region = HSR).
Aberrant Cell (typical results):
Two green (2G) and multiple copies of orange signals indicating amplification of MYC (double minute=dm).
- Rummukainen et al (2001) Mod Pathol 14:1030-1035
- Blancato et al (2004) Br J Cancer 90:1612-1619
- Singhi et al (2012) Mod Pathol 25:378-387
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.