ZytoPure® FISH Probes
Zytomed Systems is proud to offer the new product line ZytoPure® FISH, a reliable and accurate tool for the detection of genetic aberrations in FFPE tissue sections, cell samples and metaphase spreads by fluorescence in situ hybridization. ZytoPure® FISH Probes display brilliant signals, low background, and an excellent signal to noise ratio. They are intended to be used in combination with the ZytoPure® FISH Accessory Kit comprising all reagents necessary for performing a FISH procedure on FFPE sections. The kit contains just 4 reagents and includes a robust and easy to follow protocol. All ZytoPure® FISH Probes as well as the ZytoPure® FISH Accessory Kit are CE/IVD-labelled.
ERBB2/CEP17 ZytoPure® FISH Probe
The ERBB2/CEP17 ZytoPure® FISH Probe simultaneously determines the status of the ERBB2 gene and the centromeric alpha satellite sequences of chromosome 17. Amplification of ERBB2 is quite common in breast cancer (appr. 15% – 20%) and in gastric cancer [1, 2], and has been known for many years as a driver mutation . Therefore, determination of the ERBB2 status is obligatory in these tumor entities. ERBB2 codes for a growth factor receptor which can be blocked efficiently by monoclonal antibodies or small molecules. Application of these drugs in breast cancer patients is one of the earliest examples for a targeted tumor therapy based on the patient’s mutational status .
ZytoPure® FISH Probes for lung cancer
Rearrangements of receptor tyrosine kinases (RTK) ALK, ROS1, and RET determine clinically important molecular subgroups of non-small cell lung cancer (NSCLC). About 3% – 5% of all NSCLCs show an ALK rearrangement, and 1% – 2% show ROS1 or RET rearrangements . In all fusion variants, the 3´ TK domain is fused to the promotor regions and 5´ coding regions of the fusion partner. Hence, rearranged RTKs are permanently active, sending proliferation signals into the cell, and thereby promoting non-controlled cell growth. Several very efficient TK inhibitors (TKIs) were launched in recent years , and as a consequence the median survival of an ALK positive NSCLC patient treated with two ALK inhibitors is now more than 5 years ! Amplification of the MET gene is the second most common resistance mechanism of lung adenocarcinomas against EGFR TKIs . In addition, primary MET amplification is also found in a small percentage of treatment-naïve lung adenocarcinomas .
ZytoPure® FISH Probes for sarcomas
Numerous recurrent genomic rearrangements have been described in a number of bone and soft tissue tumors in the last 15 years [10, 11]. To give just a few examples, rearrangement of the USP6 gene occurs in the majority of primary aneurysmal bone cysts , and also in nodular fasciitis . SS18 rearrangement is highly specific for synovial sarcomas , and the majority of Ewing sarcomas is characterized by EWSR1 rearrangements . Amplification of the MDM2 gene typically occurs in liposarcomas (but not lipomas)
, and in certain osteosarcomas. In combination with histological and radiological findings, FISHbased detection of these rearrangements is a very important tool for the often complex differential diagnosis of these entities.
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