New platform for an accurate diagnosis and staging of Drug-Induce Liver Injury (DILI) with 'liquid biopsy'
We want to bring to market Combo LiverAce, a novel single-step Research Use Only (RUO) assay for detection of protein and microRNA (miRNA) DILI biomarkers in human serum. Combo LiverAce combines Luminex analytical platform with direct miRNA detection ChemiRNA™ Tech (DESTINA) protein multiplexing (AIT) and clinical data analysis (Datamedrix). Luminex, DESTINA, AIT and Datamedrix competencies will be combined with recognised European leaders in DILI research, to create the first multiplexed miRNA/protein Luminex Combo assay in the world.
DILI is a potentially fatal adverse event to prescription drug intake and a leading cause for pre and post-market drug withdrawal. Several multinational DILI initiatives have now suggested a panel of miRNA and protein biomarkers as the optimal combination for an assay to early detect liver injury, inform about mechanisms of liver injury and help in assigning causality. Key opinion leaders back the need for a rapid, cost-effective, easy to use and reliable assay.
Combo LiverAce will be sold by DESTINA to research centres, pharmaceutical companies and hospitals through selected distributors and licensees as an RUO assay, that can be used on current Luminex appliances. Successful commercialization of Combo LiverAce will enable its expansion to an IVD assay and the creation of similar combo assays.
DILI is second largest responsible for drug failures in clinical trials, for withdrawal from the market and warnings from regulatory authorities like Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Over 1000 drugs, either commercially available or in development, are suspected to cause DILI. Currently, DILI is a diagnosis of exclusion when an unexplained increase of liver enzymes happens (the main diagnostic tool so far). However, increased liver enzymes and symptoms of affected patients can mimic other liver diseases such as viral hepatitis, ischemic liver injury, autoimmune hepatitis and other acute and chronic liver diseases. There is a pressing need for a new assay to accurately detect and measure early expression liver injury biomarkers. Ideally, an innovative combination of biomarkers such as miRNAs and proteins would be able to clearly identify DILI, predict the course of the liver injury, and help in assigning causality, especially in the case of patients using more than one potentially hepatotoxic drugs. Many attempts have been made to develop new biomarker assays for DILI management. However, the jump from experimental bench to approved assay for use at bedsides has been unsuccessful . Also, linking miRNA and protein biomarkers of clinical relevance into a single assay has not been attempted yet. With the advances made by the partners with their technical expertise, the deliverable of a multiplexed combo assay is now seen as possible. Called Combo LiverAce, the assay will be able to simultaneously detect from a single clinical sample both miRNAs and proteins in DILI subjects' serum. This has the capacity to transform DILI assessment in this area of drug development. The Combo LiverAce assay will be benchmarked against current miRNA and protein detection gold standard assays using DILI serum samples. We expect several new patents to derive from this project.