Datametrex AI Ltd V.DM

Translated from Korean

[mytriade]

https://m.wowtv.co.kr/NewsCenter/News/Read?articleId=A202004220327

SML Genitree's Corona 19 diagnostic kit acquired the European Integrated Standard Certification (CE)

 

 

SML Genitree of Samkwang Biotree Group, a domestic diagnostic test bio group, has obtained European CE-IVD (European In vitro Diagnostic Reagent Certification) for the Corona 19 diagnostic kit 'Ezplex® 2019-nCoV Real-time PCR Kit'.  It was announced on the 21st.

 

 CE certification is an integrated standard certification that is granted only to products that meet all the requirements of the European Union (EU) Council Directives related to safety, health, and the environment.  

 

 

SML Genetree's Corona19 diagnostic kit, Ezplex® 2019-nCoV Real-time PCR Kit, utilizes the world's best multiplex technology to detect all three target genes related to COVID-19, RdRp, E, and N.  It has characteristics that can be.  In addition, it is also a key feature to increase user convenience by easily analyzing a large amount of inspection results through an automated analysis program.

 

 The clinical evaluation conducted by professional examination institutes in Korea and Japan recently showed high accuracy with 100% of sensitivity and 100% of specificity, thereby highlighting the discrimination from the domestic and foreign corona19 diagnostic kits where quality problems have recently emerged.  Ordered.  Sensitivity is the probability of actually determining an infected person as positive, and specificity means the probability of negatively determining an unaffected person. The sensitivity and specificity of 100% level is overwhelmingly high in performance compared to other diagnostic kits.  .

 

 SML Jenny Tree CEO Ji-Hoon Ahn said, "We have already signed a number of export contracts in the US, Japan, Europe, and Southeast Asia, and are producing 200,000 to 300,000 tests per week."  We expect to be able to further increase the international status of the company. "  Also, he added that the application for the US FDA Emergency Use Authorization (EUA) has also been completed.