Combined Technologies Enable Mutation Detection from Single Figures of Circulating Tumor Cells

Results from a preliminary study combining novel technologies for cell isolation and for DNA enrichment have shown successful mutation detection from as few as 1–3 circulating tumor cells.

EKF Molecular Diagnostics (Cardiff, UK) and GILUPI (Potsdam, Germany), an innovator in medical devices for in vivo isolation of rare cells directly from patient blood, have announced results from collaborative work using GILUPI CellCollector and EKF Molecular’s PointMan DNA Enrichment technologies.

The first results have demonstrated the detection of known gene mutations from as few as 3 or less cells isolated in a model in vitro system as well as from the blood of lung cancer patients. PointMan DNA Enrichment was used to detect and analyze cells with known mutation status that had been collected on GILUPI CellCollectors under laboratory conditions. The known mutations were those typically seen in lung (EGFR) and colorectal (KRAS) cancer. Positive results using PointMan assays for KRAS (codon 12/13) and EGFR (T790M and L858R) from cell lines and patients were confirmed by Sanger sequencing and showed conformance with known mutation status.

Andy Webb, CEO of EKF Molecular Diagnostics, commented, “These results are a clear indication of the utility of PointMan DNA enrichment on low cell numbers, in this case those isolated using the GILUPI CellCollector both in vitro and in vivo. We look forward to continuing this important work with GILUPI to further validate our findings. This achievement is in line with the Company’s vision to change current DNA extraction and detection practices and address the fast growing companion diagnostics market. Indeed, these new results compliment previous work on circulating free DNA using PointMan detection, which was performed by the Institute of Life Sciences (Swansea, UK) using samples archived in the Wales Cancer Bank. The GILUPI and Swansea collaborations focus on the unmet requirements for patient monitoring from peripheral samples, negating the requirement for a surgical procedure to obtain a tissue biopsy for early cancer screening, diagnosis, and during disease progression.”

Klaus Luecke, CEO and co-founder of GILUPI, said, “This is a major step forward for both companies and also for the future testing and monitoring of cancer patients. The isolation and subsequent characterization of low numbers of circulating tumor cells from the blood of cancer patients will become increasingly important as a liquid biopsy as a method to monitor disease progression and response to therapy. We hope that less-invasive and more frequent testing will become routine using our combined technologies with significant patient benefits. GILUPI is looking forward to further cooperation with EKF Molecular Diagnostics to continue to build the evidence base for the combined technologies.”

The preliminary results were presented for discussion at the EKF booth at the 50th annual meeting of the American Society of Clinical Oncology (ASCO; Chicago, IL, USA; May 30–June 3, 2014).

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