ZytoPure® FISH Probes

news September 29 2020

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 [3]. 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 [4].

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 [5]. 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 [6], and as a consequence the median survival of an ALK positive NSCLC patient treated with two ALK inhibitors is now more than 5 years [7]! Amplification of the MET gene is the second most common resistance mechanism of lung adenocarcinomas against EGFR TKIs [8]. In addition, primary MET amplification is also found in a small percentage of treatment-naïve lung adenocarcinomas [9].

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 [12], and also in nodular fasciitis [13]. SS18 rearrangement is highly specific for synovial sarcomas [14], and the majority of Ewing sarcomas is characterized by EWSR1 rearrangements [10]. Amplification of the MDM2 gene typically occurs in liposarcomas (but not lipomas)
[15], 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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[14] Tanas MR et al. Arch Pathol Lab Med 134:1797-1803, 2010
[15] Ware PL et al. Am J Clin Pathol 141:334-341, 2014