New Product News
Wuhan YZY Med independently developed “HER2 gene test kit (fluorescence in situ hybridization method)” formally passed the approval of NMPA, and obtained the Class III certificate (CNIS20233402062).
Companion Diagnosis｜Precise Detection of HER2 Amplification Status in Breast Cancer
YZY Med’s “HER2 Gene Detection Kit (Fluorescence In Situ Hybridization)” employs dual fluorescent probe technology to detect HER2 gene amplification in formalin-fixed, paraffin-embedded human breast cancer tissue samples. The kit adopts a unique oligonucleotide probe platform to prepare hybridization probes, whose length and molecular weight make it easier to enter the cell nucleus, and the coverage rate of target sequences is more than 99%, which is able to realize “2h” rapid FISH hybridization experiments with high quality.
The clinical significance of HER2 testing includes evaluating the prognosis of patients, guiding targeted medication, and rationally selecting adjuvant chemotherapy regimens. Accurate HER2 test results can better help clinics identify breast cancer patients who are suitable for HER2-targeted therapies, thus maximizing patient benefits. Ziyou Medical’s “HER2 Gene Test Kit (Fluorescence In Situ Hybridization)” can be used to assist in evaluating whether a breast cancer patient is suitable for Herceptin (trastuzumab)-related drug therapy.
Engine Driven｜RAPID FISH Oligonucleotide Probe Technology
YZY Med’s FISH platform utilizes oligonucleotide probe technology (Oligo-FISH) to interrupt genomic sequences with the help of bio informatics, establish database filtering design, eliminate potential repetitive sequences and non-specific sequences, and ultimately screen and design fluorescently labeled, highly specific probes. This platform is free from the technical limitations of traditional BAC cloning, and not only realizes “1- 2h” rapid FISH hybridization experiments with high quality, but also supports the customization service of high-resolution specific probes in small intervals.
The rapid approval of the popular HER2 product shows that YZY Med has successfully transformed the RAPID FISH rapid hybridization technology into a mature product recognized by national authorities, which has facilitated the company to take a step forward in the direction of molecular pathology diagnosis. In order to continue to help the rapid development of precision medicine, YZY Med’s FISH product line provides a total solution of “pre-treatment kit + automated equipment + fast kit combination” for clinical experiments, with the keywords of “faster” and “automation” , the entire product line has obtained nearly 200 NMPA registrations and EU CE mark, with excellent performance and legal compliance.
