US collaboration to develop blood tests for cancer

EKF Diagnostics Holdings plc (AIM: EKF), the AIM-listed point-of-care, central laboratory, and molecular diagnostics business, announces that it has entered into a two-year research collaboration with Massachusetts General Hospital (MGH), a global leader in successfully bridging innovative science with state-of-the-art clinical medicine, to develop PointMan™ assays that can effectively detect treatable cancer mutations in blood samples.

The collaboration agreement has been signed following a detailed evaluation of PointMan™ DNA enrichment technology by MGH. It will cover a two-year-long project focusing on lung, breast, and skin cancer.

MGH will use PointMan™ DNA enrichment technology to detect genetic variation in circulating tumor cells (CTCs) isolated from a patient’s blood using MGH’s CTC-Chip instrument. CTCs are shed by primary tumors, allowing the cancer to metastasize.

CTCs are extremely rare in whole blood, and their isolation and characterisation could offer clinicians a routine method for diagnosing, treating, and monitoring the progress of various cancers.

The main difficulty in successfully analysing CTCs has been the ability to detect low-level mutations sufficiently and to create assays that are sensitive enough to provide meaningful data, difficulties which PointMan™ may be able to overcome effectively.

EKF Molecular will design and develop high-sensitivity assays that will be utilised by MGH to clinically validate PointMan™ in detecting existing and novel mutations, a significant step towards improving patient outcomes in the hospital.

Andrew Webb, CEO of EKF Molecular Diagnostics Ltd, commented: “The results of an initial assessment, and now this two-year collaboration, move us even closer to the routine use of blood-based tests for cancer rather than a tissue biopsy. The combination of MGH’s CTC-Chip instrument and the easy-to-use and quick-to-perform PointMan™ technology should ultimately make this approach to cancer detection and monitoring available to most molecular testing laboratories.”

Dr Daniel A. Haber, Director at Massachusetts General Hospital Cancer Center and Kurt J. Isselbacher, Peter D. Schwartz Professor of Oncology, Harvard Medical School, commented: “We have been studying the sensitivity of DNA enrichment technology as a way to detect and monitor specific mutations in cancers from patients utilising circulating tumour cells isolated from a simple blood sample. I am hopeful that the combination of such technology with our CTC-Chip technology will potentially improve our patients’ clinical management.”

Dr Shyamala Maheswaran, of the Massachusetts General Hospital Cancer Center and Associate Professor of Oncology at Harvard Medical School, who was principal investigator for the collaboration, commented: “This study demonstrated incredible sensitivity for mutations relevant to lung cancer, breast cancer, and melanoma. During the two-year research collaboration, we will look for other potential target genes associated with these and other cancer types.”