• Including miLab™ CER, Automating cervical cytology and analysis

(Yongin, Korea) August 31st, 2022 – Noul Co., Ltd., (376930.KR), a KOSDAQ-listed biotech startup, has obtained CE-IVD marks for two of its products. Based on this mark, Noul plans to enter major global in-vitro diagnostic markets including Europe.

Noul’s next-generation diagnostic testing products that obtained CE-IVD are miLab Cartridge CER, a cervical cell staining and analysis solution, and miLab Cartridge BCM, a morphology-based blood analysis solution.

The miLab™ Cartridge CER is an in-vitro diagnostic medical device that stains cervical cytology specimens using the Papanicolaou stain method. When used with Noul’s miLab™ Platform, the miLab™ Cartridge CER automatically stains and analyzes the cervical cells to aid the medical professionals’ slide review. The miLab™ Cartridge BCM performs automated microscopic examination for blood cells such as white blood cell differential count. 

The miLab™ Cartridge CER, improves the efficiency of tests for cervical cancer, the fourth most common cancer in women. The miLab™ Cartridge BCM improves the quality of the sample preparation and the efficiency of tests for peripheral blood smears.

David Lim, a CEO of Noul, said “The acquisition of CE mark for two miLab™ cartridge solutions is significant in that it has expanded the marketability of diagnostic testing areas from the existing malaria diagnosis to peripheral blood and cancer areas. As miLab™ has met regulatory requirements in the European market, we will accelerate our product’s entry into major global markets including Europe and Africa where it references CE certification.”

Medical devices and in-vitro diagnostic devices sold in EU member states are required to obtain certification for CE mark, which guarantees the safety of products distributed in the European market. Noul’s miLab™ Platform and miLab™ Cartridge MAL already obtained CE-IVD mark in February 2021.

Website www.noul.com