EKF Molecular Diagnostics and GILUPI announce CTC DNA enrichment success

EKF Molecular Diagnostics and GILUPI, an innovator in medical devices for in vivo isolation of rare cells directly from a patient’s bloodstream, announces results from collaborative work using GILUPI CellCollectorTM and EKF Molecular’s PointMan™ DNA Enrichment technology.

The first results of a collaboration between EKF Molecular Diagnostics and GILUPI have successfully demonstrated the detection of gene mutations from as few as three cells isolated in a model in vitro system and from the blood of lung cancer patients.

PointMan™ DNA Enrichment was used to detect and analyse cells with known mutation status 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 with known mutations and patients were confirmed by Sanger sequencing and showed conformance with known mutation status.

Andy Webb, CEO of EKF Molecular Diagnostics, commented: “These results clearly indicate 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 vital work with GILUPI to validate our findings further. This achievement aligns with the Company’s vision to change DNA extraction and detection practices and address the fast-growing companion diagnostics market. Indeed, these new results complement 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 significant step forward for both companies and also for the future testing and monitoring of cancer patients. The isolation and subsequent characterisation of low numbers of circulating tumour cells from the blood of cancer patients will become increasingly important as a liquid biopsy method to monitor disease progression and response to therapy.

We hope 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 will be available for discussion at the EKF Booth at ASCO (May 30th – June 3rd, 2014, Booth 4109, McCormick Place, Chicago, IL).