Diagnostic device start-up Noul has secured the CE-IVD mark for two of its next-generation miLab cartridge diagnostic testing products.
Noul has now CE-IVD marking for its miLab cartridge CER, a cervical cell staining and analysis solution and miLab Cartridge BCM, a morphology-based blood analysis solution.
Based on the CE approval, the biotech start-up aims to enter the global in-vitro diagnostic markets including Europe.
miLab cartridge CER is an in-vitro diagnostic medical tool that uses the Papanicolaou stain procedure to colour cervical cytology samples.
It automatically stains and evaluates cervical cells when used with Noul’s miLab Platform to facilitate the slide evaluation by medical professionals.
Using the miLab Cartridge BCM, automated microscopic analysis can be done for blood cells such as white blood cell differential count.
According to the firm, cervical cancer is the fourth most frequent malignancy in women, and the miLab cartridge CER increases the effectiveness of tests for it.
The miLab cartridge BCM boosts the accuracy of testing for peripheral blood smears and the calibre of sample preparation.
Noul CEO David Lim 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.”
The CE mark certification is necessary for the sale of medical and in-vitro diagnostic devices in EU member states since it ensures the security of goods supplied on the European market.
In February last year, Noul’s miLab Platform and miLab cartridge MAL received the CE-IVD mark.
