【New Product News】
Yzy Med’s FISH product line has gained another new member of Class III certificate! The “ALK Rearrangement Detection Kit (Fluorescence In Situ Hybridisation)” independently developed and manufactured by Wuhan Yzy Med has officially passed the approval of the National Drug Administration (NMPA), and has obtained the Class III Medical Device Registration Certificate (CNIS20243401108).
Recently, the National Cancer Center (NCC) recently released the latest burden of malignant neoplastic diseases in China on JNCC. In 2022, there will be 2,574,200 cancer deaths in China, and the number of lung cancer deaths will be as high as 733,000, which will account for 28.5% of the total number of cancer deaths. According to the WHO classification, lung cancer is mainly divided into small cell carcinoma and non-small cell lung cancer (NSCLC), of which NSCLC accounts for about 85%.
Studies have shown that the occurrence of ALK gene rearrangement mediates the formation of ligand-independent ALK dimers and the continuous activation of the kinase structural domains, which leads to carcinogenesis, and the mainstream detection methods include second-generation sequencing, fluorescence in situ hybridization, and immunohistochemistry. For known types of ALK fusion, fluorescence in situ hybridization (FISH) is the gold standard for detecting ALK gene fusion with reliable and accurate results. FISH has the characteristics of high sensitivity and specificity, and can be detected in situ on tissues to visualize ALK gene alterations.
Yzy Med’s “ALK gene rearrangement detection kit (fluorescence in situ hybridization)” adopts a unique oligonucleotide probe technology, whose molecular weight is smaller and easier to enter the cell nucleus, and is able to realize “2h” rapid FISH hybridization experiments with high quality, which is suitable for qualitative detection of whether ALK gene rearrangement exists in formalin-fixed paraffin-embedded NSCLC samples to help determine whether patients are suitable for receiving Crizotinib capsules treatment. It is suitable for qualitatively detecting the presence of ALK gene rearrangement in formalin-fixed paraffin-embedded non-small cell lung cancer tissue samples to help determine whether patients are suitable for treatment with Crizotinib Capsules (Xalkori).
ALK Rearrangement Test Kit (Fluorescence In Situ Hybridization)” is the second accompanying diagnostic NMPA Class III registration certificate for Yzy Med’s FISH platform, following the HER2 amplification test, which once again promotes the company’s “seeing is believing” step in the direction of molecular diagnostics. The company has once again taken a big step in the direction of molecular diagnostics, “seeing is believing”. Since the approval of the first-generation targeted drug crizotinib, three generations of ALK-TKI drugs have been used in the clinic, bringing significant clinical benefits to ALK-positive advanced NSCLC patients.
Engine Driven｜Fast Heterogeneous FISH Oligonucleotide Probe Technology
Using Oligo-FISH (oligonucleotide probe) technology, Yzy Med’s FISH platform not only realizes “1- 2h” fast FISH hybridization experiments with high quality, but also supports the customization of high-resolution specific probes for small intervals by getting rid of the technical limitations of the traditional BAC cloning.
Total Solution｜FISH Total Lifecycle Management
From the perspective of clinical needs, Yzy provides a total solution of “pre-treatment kits + automated equipment + fast hybrid probe combinations” for clinical experiments with the keywords of “faster” and “automation”. Our product line has obtained nearly 200 NMPA registration certificates and CE certification, with excellent performance and legal compliance.
