LEUKOCARE AG and Trillium Diagnostics, LLC have announced that both partners have formed a strategic alliance regarding the development and marketing of LEUKOCARE’s patented method for the detection of inflammatory activity using the novel biomarker circulating cell-free DNA (cf-DNA).
Trillium will use the technology to develop a commercial assay for the diagnosis of sepsis.
Neutrophil-derived DNA is the major component of cf-DNA, which has recently been recognized as an important predictive biomarker in severely ill patients with acute or chronic inflammatory disorders.
LEUKOCARE has granted to Trillium an exclusive, royalty-bearing license of its patent and know-how for the method of measuring the quantity of cf-DNA to develop a commercial IVD assay kit for the worldwide market.
Trillium intends to establish a cf-DNA test as a simple and cost effective tool for healthcare professionals to obtain clinically informative data on patients with suspected infection/sepsis.
The development process is expected to return an approved and marketable assay in about 2 years’ time.
"A prognostic assay for sepsis will represent a tremendous improvement in intensive care medicine," said Bruce Davis, M.D., CEO and President of Trillium Diagnostics.
Davis continued, "It clearly would fulfil an unmet medical need to help identify sepsis patients at early stage and to initiate rapid treatment actions."
Dr Davis added, “cf-DNA is an important addition to our patented infection/sepsis diagnostic assays of neutrophil CD64 expression (Leuko64 assay) and soluble CD163 (Macro163 assay). We hope these three assays used in parallel will provide unparalleled sensitivity and specificity in diagnosis.”
Michael Scholl, CEO of LEUKOCARE, said: “We have found a strong and competent partner in Trillium. Its pertinent expertise in developing and marketing diagnostic assays will make the best use of the potential of the cf-DNA biomarker. LEUKOCARE will participate in the future success of the product by significant royalties.”