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EKF MDx, Gilupi Partnership Yields Data on CTC DNA Enrichment, Mutation Detection

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NEW YORK (GenomeWeb) —EKF Molecular Diagnostics said today that its collaboration with circulating tumor cell firm Gilupi in the area of CTC DNA enrichment has yielded positive results.

EKF said that by using its PointMan DNA enrichment technology with Gilupi's CellCollector platform, scientists from the company were able to detect gene mutations from three or fewer cells isolated in a model in vitro system and from the blood of lung cancer patients.

More specifically, the collaborators used PointMan DNA enrichment to detect and analyze cells with known mutation status that have been collected using the CellCollector platform under laboratory conditions, EKF said. The known mutations, confirmed with Sanger sequencing, were those typically seen in lung and colorectal cancers, including codon 12/13 of KRAS and the T790M and L858R EGFR mutations.

EKF plans to present preliminary data from the collaboration at the American Society of Clinical Oncology meeting next week in Chicago.

EKF Molecular Diagnostics CEO Andy Webb said in a statement that the 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."

Webb also noted that the results complement previous work on circulating free DNA using PointMan detection performed by the Institute of Life Sciences in 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 [and] diagnosis, and during disease progression," Webb said.

EKF's PointMan technology determines the presence or absence of DNA mutations with a high degree of sensitivity through PCR amplifying mutant sequences and suppressing amplification of wild-type sequences. According to the company, the technology can detect one mutant gene in 10,000 normal gene copies.

EKF Molecular Diagnostics is a Cardiff, UK-based subsidiary of EKF Diagnostics that was created in March 2013 to support the company's foray into molecular and companion diagnostics. At the same time it acquired cancer diagnostics firm 360 Genomics for up to £9.6 million ($14.5 million at the time).

Gilupi, based in Potsdam, Germany, is a medical device company that develops products for in vivo isolation of rare cells from circulation. The company's CellCollector technology uses biocompatible surface polymers that prevent undesirable interactions with blood components and can bind antibodies, thus enabling the enrichment of specific target cells from blood.

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