The European Patent Office has issued a decision to grant a patent for an invention entitled “microRNA biomarkers in blood for diagnosis of Alzheimer's Disease” (EP3449009). The document claims a panel of microRNA biomarkers which allows early, minimally invasive diagnosis of Alzheimer’s Disease (AD). The invention was created as a result of research carried out at the Nencki Institute Laboratory of Preclinical Testing of Higher Standard, and International Institute of Molecular and Cell Biology in Warsaw, Laboratory of Neurodegeneration, under the direction of Prof. Urszula Wojda, PhD, DSc and Prof. Jacek Kuźnicki, PhD, DSc respectively.

Individual microRNAs utilised in the panel may be used to monitor signaling pathways associated with AD pathomechanisms, thus making the panel a diagnostic tool for personalized AD therapy. This is a particularly innovative and unique element of the invention. A detailed description of  research results that led to the invention has been published in Oncotarget (Nagaraj et al. 2017) and Ageing Research Reviews (Nagaraj et al. 2019). The inventors have also published some of the results indicating that selected microRNAs can be used to select personalized therapy (e.g. Nagaraj et al. 2021).

The diagnostic tool claimed in the patent may be used as i.a.:

1. a screening test for early detection of AD,
2. a test for monitoring of the treatment response and AD progression,
3. patient stratification tool in clinical trials for new AD therapies,
4. a tool for personalized AD therapy selection.

All 15 microRNAs identified in blood plasma (or a selected subgroup thereof) which are claimed in the patent may be used to diagnose the prodromal stage of AD, before clinical symptoms occur. The uncomplicated, minimally invasive, and relatively inexpensive procedure of microRNA detection utilized in the patented method provides a significant advantage over other existing AD diagnostic tools. Currently, the lack of minimally invasive tests for early diagnosis of AD limits options for disease treatment with existing therapies as well as the development of new drugs. The patented microRNA panel provides a solid basis for overcoming these barriers.

While the patented analysis of microRNA levels is conducted based on real-time PCR results, Prof. Wojda's team is also working on a different approaches to address some of the real-time PCR method limitations. In the process of research and development, the team has also established protocols for a stable and reproducible normalization and control of microRNA assays, which could be a critical milestone in the context of using microRNAs as biomarkers not only for Alzheimer's disease, but for many other conditions.

The research that led to the invention was financed by:

• EU FP6/2012-2015 Programme, 2/BIOMARKAPD/JPND/2012 "Biomarkers for Alzheimer’s disease and Parkinson’s disease”,
• EU HORIZON2020 Marie Skłodowska-Curie grant agreement no 665735 (Bio4Med-PhD),
• EU HORIZON2020 FETOPEN Research & Innovation Action, grant agreement no 737390 „The screening, diagnostic and therapy of Alzheimer’s disease (ARRESTAD)”,
• Polish NCN OPUS grant 2018/29/B/NZ7/02757 "MicroRNAs in blood as biomarkers for Alzheimer's disease: a molecular signature for personalized therapy".

The Institute is seeking a partner in the process of commercialization of the invention.

For more information please contact dr. Dorota Gierej-Czerkies
Tel. +48 22 5892 263
d.gierej-czerkies@nencki.edu.pl