QTRACE® Analysis System Attains CE Mark

JETA Molecular is pleased to announce that earlier this year, we filed a Declaration of Conformity to CE IVD-D standards for our flagship chimerism product, the QTRACE® Analysis System.

The QTRACE® Analysis System utilizes qPCR-based detection of insertion/deletion polymorphisms in the human genome for the in vitro, quantitative measurement of recipient-derived genomic DNA levels, as an aid in monitoring donor engraftment and disease relapse after allogeneic stem cell transplantation.

The content within QTRACE®’s core 46 member assay panel has become the standard against which other tests are now judged. With the recent introduction of our Chimerism Extended Panel of an additional 34 novel variants, JETA now offers 80 unique bi-allelic loci for monitoring. The resolution of this entire system approaches that afforded by traditional Short Tandem Repeat testing. There is no other commercial qPCR offering which is closely comparable to QTRACE®’s probability of identifying unique genetic loci between HLA-matched siblings involved in stem cell transplants.

Our recent Declaration of Conformity for the QTRACE® Analysis System comes as a result of the exceptional quality and regulatory support of QARAD BV, Geel, Belgium. JETA was founded just over four years ago, and in that time, QARAD worked to establish JETA’s QMS and led the way to our first CE Mark.

This recent CE Declaration further demonstrates JETA's commitment to continuous quality improvements in our products and services.