Breaking News: Hymon Receives 3 CE Certifications for 3 Products


Breaking News: Hymon Receives 3 CE Certifications for 3 Products

Using innovative technologies, HymonBio has, time and time again, overcome difficulties created by the COVID-19 epidemic. And now, for another piece of good news: HymonBio has received CE certifications for their HAEMOCERT™ Blood DNA Colorectal Cancer Screening Test, the Hymon® MULTONE™ Urogenital Panel Test Kit, and the Hymon® MULTONE™ Respiratory Panel Test Kit. This is a new achievement to add to many after obtaining FDA EUA and successful registration in Indonesia, Myanmar, and many other countries.

The noninvasive detection method of HAEMOCERT™ Blood DNA Colorectal Cancer Screening Test utilizes gene methylation and gene mutation. Simultaneously, it combines the unique nano-magnetic bead extraction and molecular lock technologies; extraction efficiency of low concentrations of small fragment cell-free nucleic acid, sensitivity, and specificity are greatly improved. Clinical studies for early detection show sensitivity at 96% and specificity at 94%. A noninvasive blood test is adopted for this test, making sampling more convenient with better compliance rates.

The Hymon® MULTONE™ Respiratory Panel Test Kit can simultaneously detect 12 respiratory pathogens, including: SARS-CoV-2, influenza A (FluA), influenza B (FluB), respiratory syncytial virus (RSV), coronavirus, human metapneumovirus (MPV), human rhinovirus/enterovirus (HEV), parainfluenza virus (PIV), adenovirus (ADV), mycobacterium tuberculosis complex (MTC), mycoplasma pneumoniae (MP), Bordetella pertussis (BP).


Finally, the Hymon® MULTONE™ Urogenital Panel Test Kit silmultaneously covers 18 STDs, including: herpes simplex virus 1/2 (HSV-1/2), human papillomavirus 6/11 (HPV 6/11), treponema pallidum (TP), Neisseria gonorrhea (NG), Rickettsia trachomatis (TC), trichomonas vaginalis (TV), mycoplasma genitalium (MG), ureaplasma spp. (UP), mycoplasma hominis (MH), atopobium vaginae (AV), Gardnerella vaginalis (GV), Prevotella spp. (PT), megasphaera spp. (MS), Mobiluncus spp. (ML, including M. curtisii and M. mulieris), Candida spp. (CD), bacterial vaginosis associated bacteria 2 (BVAB2), Sneathia spp./Leptotrichia spp. (LT), Dialister spp. (DL).


Product Advantages:

•Multiple tests in one kit: More than 10 pathogens at once.

•Rapid detection: RNA/DNA is processed in a single step, and results can be obtained in as fast as 35 minutes.

•Multiple monitoring: Uses unique DIDC quality control, with positive, negative, and human internal standards for quality assurance.


The kits have been developed independently by HymonBio and have obtained EU certifications, indicating our products meet the requirements of EU directives and conditions of the EU marker. It allows us to lay a solid foundation for development in the European market.

Post time: Apr-29-2022