Noul has acquired European In Vitro Diagnostic Medical Device (CE-IVD) certification for two types of miLab cartridge solutions.
CE-IVD certified products are miLab Cartridge CER, a cartridge solution for cervical cytology, and miLab Cartridge BCM, a cartridge solution for blood cell morphology.
Based on CE certification, Noul plans to enter global in vitro diagnostic markets, including Europe.
The Company’s miLab CER cartridge is an in vitro diagnostic medical device that stains cervical cell samples using the Papanicolaou staining method. It is a cartridge solution that automatically stains and analyzes cervical cells.
When used with Noul’s miLab platform, it provides cellular analysis results to facilitate sample staining, imaging and reading by healthcare professionals.
Noul aims to improve diagnostic efficiency for cervical cancer, the fourth most common cancer in women worldwide, by using miLab Cartridge CER for cervical cancer diagnostic testing.
MiLab Cartridge BCM is a cartridge solution that performs automated microscopy of primary blood cells, including white blood cell differentiation counting, in blood samples.
The company plans to reduce analyst analysis time by demonstrating consistent sample quality and AI results with BCM’s automated sample preparation capabilities.
“The CE certification for both miLab cartridge solutions is significant in that it has expanded the commercialization of diagnostic test areas from existing malaria diagnostics to peripheral blood and cancer areas,” said the co-CEO. of Noul, Lim Chan-yang. “As it has met the regulatory requirements of the European market, we plan to accelerate entry into major global markets such as Europe and Africa where CE certification is accepted.”