VEDBAEK, Denmark — In a multicenter study, Exiqon, in collaboration with LEO Pharma, Bispebjerg Hospital, Gentofte Hospital, Copenhagen University Hospital and University of Copenhagen, has identified promising diagnostic biomarkers of cutaneous T cell lymphoma (CTCL) to distinguish between malignant and benign inflammation – i.e. between CTCL and chronic diseases such as psoriasis, atopic dermatitis and eczema. The results have been published in the well-esteemed journal “Blood, Journal of the American Society of Hematology”, which is available at: https://bloodjournal.hematologylibrary.org/content/early/2011/08/23/blood-2011-06-358382

The initial screening was conducted by use of Exiqon’s proprietary microarray platform. Subsequently the biomarker profile was transferred to Exiqon’s proprietary microRNA qPCR platform for validation. In a blinded test set specificity and sensitivity of 97% and 93% respectively were obtained. Currently, no test is available for unambiguous discrimination between early malignancy and benign inflammation. Accurate diagnosis and early treatment are crucial for successful treatment.

Senior Research Scientist Mads Roepke, LEO Pharma, estimates that the study result could lead to more efficient diagnostic methods: “The discovery of this microRNA classifier can form the basis of a potentially very important test that will hugely simplify the diagnosis of dermatological diseases and separate inflammatory conditions from early malignancy. Such a test can be of value for both patients and clinicians”.

Also commenting on the study, VP Diagnostics, Adam Baker from Exiqon says: “This program is very exciting and is a great demonstration of how Exiqon’s arrays can be applied to screen for promising biomarkers, which subsequently can be transferred to our qPCR platform for sensitive identification of biomarkers in skin biopsies”.

Exiqon and LEO Pharma intend to jointly examine the possibilities of developing this biomarker profile into a companion diagnostic product for the accurate diagnosis and differentiation between malignant and non-malignant skin diseases. Such a companion diagnostic product could impact the diagnostic capabilities in dermatological practice world-wide. The misclassification and subsequent wrong treatment of cutaneous malignancies such as CTCL can have life-threatening implications for patients.

The study is supported by The Danish National Advanced Technology Foundation.