Leukemia Fusion Genes Screening Kit Gets CE IVD Status

The Leukemia Fusion Genes screening kit has been released as a Conformité Européenne In Vitro Diagnostic (CE-IVD) product under the European Directive for In Vitro Diagnostic Medical Devices.

The screening kit provides a sensitive, specific, reliable and cost-effective tool that is easy to perform for the routine screening of leukemia fusion transcripts. The ability to detect cancer specific fusion genes is important in clinical settings to ensure that correct diagnosis is made and the optimal treatment is chosen.

Leukemia Fusion Genes (Q30) Screening Kit (QuanDx Inc.; San Francisco, CA, USA) is a qualitative in vitro diagnostic device for use in a clinical laboratory for the simultaneous detection of 30 fusion genes utilizing a novel multiplex reverse transcription real-time polymerase chain reaction (PCR) system. Fusion and control gene transcripts are co-amplified in each reaction and identified by specific fluorescent probes. Leukemia Fusion Genes (Q30) will transform current testing to provide a more efficient and economical system for optimizing patient testing as current methodologies to detect such fusion genes all have distinct shortcomings. The results of the test are ready in two to three hours.

Matthew Lei, PhD, Chief Executive Officer of QuanDx Inc., said, “This marks another significant step for our company and compliments our ISO 13485: 2003 certification in March. We have implemented the internal quality and regulatory processes necessary to move from selling a research use only product to an in vitro diagnostic product. CE marking demonstrates our commitment to provide quality diagnostic products to the European market. This is our first in vitro diagnostic product. 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.”

Graeme Duncan, Vice President of Sales and Marketing at QuanDx, commented: “The CE marked Leukemia Fusion Genes product will be available in the European market beginning June 2015. The CE mark assures laboratories and clinicians that they can rely on Leukemia Fusion Genes Screening Kits to provide accurate results in their assessment and classification of hematological malignancies. The CE-IVD status of this Leukemia Fusion Genes (Q30) Screening Kit allows us to continue to expedite our plans to enter the clinical market in Europe in what is a key area of growth outside the USA.”

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