NEW YORK (GenomeWeb) – QuanDx yesterday announced that its Leukemia Fusion Genes (Q30) Screening Kit has received the CE-IVD mark.
The qualitative molecular diagnostic test detects 30 fusion genes using multiplexed RT-PCR.
"This marks another significant step for our company and compliments our ISO 13485:2003 certification in March," QuanDx CEO Matthew Lei said in a statement. "The release of our CE marked product line is expected to expand the use of our assays for the identification of fusion genes in hematologic malignancies. We will continue to work towards CE marking of our other key signature products during the remainder of 2015."
The product will be available in the European market this month, QuanDx VP of Sales and Marketing Graeme Duncan added.