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Clinical ddPCR Diagnostic Test System Gets FDA Clearance

By LabMedica International staff writers
Posted on 07 Mar 2019
A test designed for monitoring treatment response in chronic myeloid leukemia and is also the first-ever digital polymerase chain reaction (PCR) product to receive US official government approval.

The test uses a clinical instrument, called the QXDx AutoDG Droplet Digital ddPCR System. More...
It is designed to give users the flexibility to run US Food and Drug Administration (FDA, Silver Springs, MD, USA) -cleared in vitro diagnostic medical device (IVD) tests, as well as laboratory developed tests, and uses a simple, user-friendly workflow that is also scalable.

The QXDx BCR-ABL %IS Kit was CE marked in late 2017. The test uses Bio-Rad's clinical instrument, called the QXDx AutoDG ddPCR System. It quantifies BCR-ABL fusions, specifically p210 transcripts, and can detect the residual levels seen in patients on tyrosine kinase inhibitor therapy. Measuring residual levels of BCR-ABL in chronic myeloid leukemia (CML) patients treated with the first-line tyrosine kinase inhibitor (TKI) imatinib, for example, can help physicians decide whether it might be necessary to start a second-line TKI, such as dasatinib, nilotinib, or bosutinib.

Digital PCR-based methods can offer lower levels of resolution than standard quantitative reverse transcription PCR (RT-qPCR). Bio-Rad's new test can detect molecular response down to MR 4.7 (LOD), or 0.002% on an International Scale, according to the firm's website, with levels of BCR-ABL between 0.01% and 0.001% defining a so-called deep molecular response that predicts better long-term outcomes.

Bio-Rad introduced ddPCR as a research tool in 2012, and it was quickly adopted for liquid biopsy and rare mutation detection in cancer research, the firm noted in a statement. To date, there are more than 3,400 publications citing the ddPCR technology, including more than 900 publications focused on liquid biopsy.

Related Links:
US Food and Drug Administration


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