• Letter of Statement

    Date of issue:2021-08-15

  • New Gene Test Got Mutual Recognition in EU

    Date of issue:2021-07-15

    New Gene COVID-19 Antigen Detection Kit got approved and recognized by European Union to be listed into the EU common list with mutual recognition by European member states. EU common list is published and agreed by the Health Sec...

  • Good News in Succession!NEWGENE Got Self-test Approval in France

    Date of issue:2021-05-15

    On May 14, NEWGENE COVID-19 Antigen Detection Kit is approved for self-test use in France by ANSM. This is following the self-test approval after Germany, Belgium, Denmark, Sweden, Czech Republic. France and Germany are the key countries...

  • NEWGENE Gets BfArM Self-test Approval in Germany

    Date of issue:2021-05-15

    NEWGENE COVID-19 Antigen Detection Kit obtained the emergency authorization from German Federal Agency for Medicines and Medical Devices (BfArM) for home use, and is listed as self-test(GZ 5640-S-296/21). The validity is until 11th Augus...

  • Letter of Declaration

    Date of issue:2021-05-12

  • Double happiness is coming! NEWGENE products while obtaining Belgium , Sweden self-test license

    Date of issue:2021-04-22

    4 Yue 2 0 , 2 1 Ri, NEWGENE new crown antigen detection reagents were obtained Belgian Ministry of Health ( FAMHP ) approval and the Swedish Medical Products Agency ( S wedish Medical Products's Ag ency ) approval , can be used as a self...

  • Registration of NEWGENE COVID-19 Product in the Swiss FOPH

    Date of issue:2021-03-16

    Recently, NEWGENE COVID-19 Antigen Detection Kit is registered in the Swiss Federal Office of Public Health (FOPH), which will assist Switzerland and neighboring countries in large-scale screening. The Swiss Federal Office of Public Heal...

  • NEWGENE Assists the Fight Against Epidemic

    Date of issue:2021-03-06

    At present, NEWGENE novel coronavirus antigen and antibody detection products have been registered in many countries, including Germany, Italy, Czech Republic, Belgium, Hungary, Portugal, Greece, Moldova, Peru, Argentina, Ecuador, Kenya,...

  • NEWGENE Products Show Superior Performance worldwide

    Date of issue:2021-03-06

    Recently, NEWGENE novel coronavirus antigen detection products have passed the clinical validation in national labs in Switzerland, Kenya, Zimbabwe, Ecuador etc. NEWGENE products show good performance in sensitivity and specificity compa...