Glioblastoma Chemotherapy Prognosis Predictive Diagnosis Product Approved by Ministry of Food and Drug Safety
SEASUN BIOMATERIALS, Glioblastoma Chemotherapy Prognosis Predictive Diagnosis Product Approved by Ministry of Food and Drug Safety
SEASUN BIOMATERIALS, a molecular diagnostics company, has developed 'Epi-TOP mMGMT Detection Kit' (Epi-TOP MGMT), an MGMT methylation diagnostic product for predicting the prognosis of a treatment for glioblastoma, a malignant brain tumor. ) announced on the 17th that it had obtained domestic approval.
This product can check the presence or absence of methylation of the MGMT gene, which reduces the drug effect of AstraZeneca's 'Temodal Capsule' (ingredient name: Temozolomide, TMZ), a standard chemotherapy drug prescribed for glioblastoma patients.
Glioblastoma is a type of brain tumor with a 5-year survival rate of only 7%, and patients with methylation of the MGMT gene are given other prescriptions due to the low anticancer effect of temozolomide.
Gene methylation is an epigenetic genetic mutation that causes various diseases, including cancer, due to environmental factors such as aging, obesity, smoking, environmental pollution, and eating. It is a phenomenon. Recently, gene methylation has been widely discovered in the process of cancer development and is emerging as a new molecular diagnostic biomarker for cancer diagnosis.
The existing gene methylation analysis method selectively detects methylated genes by treating bisulfate chemicals, and the experimental process is complicated and takes a long time to test.
Above all, high technology and diagnostic know-how were required to optimize molecular diagnostics due to the low reproducibility of the most important results in molecular diagnostics. It was accepted.
On the other hand, SEASUN BIOMATERIALS' 'Epi-TOP MGMT' has no bisulfate treatment process, so the test method is simple, and it uses a new concept real-time PCR to analyze methylation within 3 hours using a single device. And it is possible to check the reading result.
Park Hee-kyung, CEO of SEASUN BIOMATERIALS, said, “Through epigenetic genetic mutation analysis, we are establishing biomarkers in various carcinomas such as lung and pancreatic cancer, including glioblastoma, and developing related diagnostic products. We hope to contribute to the prediction of prognosis and the realization of precision medicine.”
Since its establishment in 2012, SEASUN BIOMATERIALS has been using its proprietary molecular diagnostic technology to conduct congenital hearing loss, prenatal non-invasive fetal chromosomal aberration testing (NIPT), microsatellite instability (MSI) genotyping screening to determine whether to prescribe immunotherapy, etc. COVID19 We developed a diagnostic kit.
In July, it received diagnostic biomarker advanced technology certification from the Ministry of Trade, Industry and Energy, and in September, it was designated as a 'high-tech company' by the Ministry of Science and ICT.
https://mdtoday.co.kr/news/view/1065589138575628
http://www.economytalk.kr/news/articleView.html?idxno=218187
https://www.kpanews.co.kr/article/show.asp?idx=228337&category=D
