Recently there have been rapid achievements in molecular biology, especially in nucleic acid testing, It has been widely applied to pathology studies. In 2005, the Molecular Medical Lab was established and starting clinical operation the following year. As the cases and the demand for molecular testing increased, the second floor of the laboratory was renovated to accommodate an independent molecular medicine laboratory. With specifications conforming to the strict requirements of a molecular biology lab, it was reconstructed in 2010 and equipped with advanced instruments within separated working areas with adequate airflow to provide high-quality and accurate tests. In the same year, our molecular medicine lab obtained its initial accreditation by TAF (Taiwan Accreditation Foundation, ISO 15189). In 2012 our lab was also certified by the Taiwan Society of Pathology as a molecular pathology laboratory. Since 2017, the field of NGS has been developed. Currently, a variety of Panels are provided for customers to choose from for breast cancer and lung cancer.
Currently, there are three major points of focus for the lab.
1.Hepatitis B and C test applications:
We use vitro diagnostic reagent kits (real-time PCR methods) approved by TFDA for the hepatitis B & C viral load tests and hepatitis B & C genotyping tests. We also provide laboratory developed hepatitis B drug-resistant mutation test for helping physicians in choosing the adequate treatment for infected patients.
2.Human Papillomavirus (HPV) Test:
Use TFDA-approved in vitro diagnostic (IVD) reagents for HPV genotyping, including high-risk, low-risk, and genotypes 16 & 18.
Pharmacogenetic related tests
Currently provides HLA-B1502 and HLA-B5801 (IVD reagents) tests for serious drug reactions induced by carbamazepine and allopurinol. We also use laboratory developed tests for detecting UGT1A1 polymorphism for colorectal cancer chemotherapy, and tests for detecting ADH1B and ALDH2 polymorphism for alcohol metabolism. We have recently completed the MAYZENT drug metabolism gene CYP2C9 test and provided testing services.
cobas® 4800 System 全自動核酸純化儀& 可霸斯即時PCR分析儀
NGS 品質分析 Sequencing Analysis Viewer
Genetics testing for cancer target therapy
By using the fluorescence in situ hybridization (FISH) technique, we can confirm the presence of HER2/neu gene amplification in breast cancer, and c-met gene amplification in lung cancer. Moreover, the FISH method could be used for detection the presence of ROS1 gene rearrangement in non-small cell lung cancer cells. Using the MALDI-TOF technique, the presence of mutation in the KRAS, NRAS and BRAF genes can also be detected for colorectal cancer. We also provide tests detecting mutations in the EGFR gene of Non-small Cell Lung Cancer (NSCLC) cells and/or in patient’s plasma. For melanoma, the BRAF mutation test is also tested by using laboratory developed pyrosequencing test. We also provide MGMT promoter methylation status assay for Glioblastoma and microsatellite instability (MSI) for many cancers.
In addition, we provide various next-generation gene sequencing panels (Archer FusionPlex Lung Panel、Archer VariantPlex CTL Panel、Archer VariantPlex BRCA + PALB2 Panel、Ampliseq for illumina Focus Panel、NGS test for pathogenic genes related to abnormal fatty acid metabolism in neonates) for related cancer treatment, such as breast/ovarian cancer (BRAC1/2+PALB2) and lung cancer, and gene fusion (Fusion gene includes ALK、ROS1、FGFR、NTRK...etc.) panel. All these testing results are important references for current cancer target therapies. We also provides research labs, biotechnology companies and pharmaceutical companies related testing project development and testing services, not only assisting in technique development, but also providing high-quality clinical test results, in order to have better research results published to meet the purpose of our services. Recently, we also launched the PIK3CA gene mutation test for breast cancer and the FGFR gene mutation test for urothelial carcinoma.
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