Diamir Biosciences has received a patent in the European Union covering the use of microRNAs (miRNAs) – small non-coding RNA molecules that modulate gene activity – as biomarkers for the diagnosis of amyotrophic lateral sclerosis (ALS).
The patent “Methods for using miRNAs from body fluids for the detection and differentiation of neurodegenerative diseases” was registered by the European Patent Office under number 3433381. It expires in March 2037. Diamir now owns 52 patents worldwide covering the use of miRNA analysis in body fluids for early detection of diseases, differential diagnosis and disease and aging monitoring in a range of diseases.
“The approval of this new patent by the European Patent Office further strengthens DiamiR’s global (intellectual property) portfolio focused on early detection, prediction of disease progression and monitoring of brain health and other diseases,” said Dr. Samuil Umansky, Chief Scientific Officer at Diamir, in a company press release.
miRNAs help develop a “disease signature”
Because there is no specific test for ALS and the disease shares symptoms with other neurological disorders, confirming an ALS diagnosis can be a long process and is generally based on monitoring symptom progression and tests to rule out other conditions.
To solve this problem, Diamir is working on a technology to examine the concentration of certain miRNAs in blood samples or other body fluids in order to better diagnose and monitor a specific disease.
MicroRNAs are small RNA molecules that regulate gene activity by binding to messenger RNA, the intermediate molecules created when genes are read to make a protein, and preventing them from being translated into a protein. This can affect the synthesis of certain proteins and alter some cellular functions.
Depending on the disease, the levels of different miRNAs can vary significantly among patients, creating a specific disease signature. These “signature” biomarkers are useful for distinguishing people with a particular disease from healthy people, distinguishing a disease from similar diseases, or even monitoring patients for the severity of their disease and their response to treatment. Such a biomarker signature is particularly useful when the molecules can be detected in a minimally invasive way, such as through a simple blood or urine test.
Diamir has been trying to identify combinations of different disease-associated miRNAs that could distinguish one neurodegenerative disease from another, or a person with a neurodegenerative disease from a healthy person. Previous results have shown that combinations of two or three different blood miRNAs work well as a diagnostic tool for people with diseases such as ALS and frontotemporal dementia, a related disorder.
“In Diamir’s ongoing biomarker programs, our primary goal is to provide researchers and clinicians with minimally invasive, precise molecular solutions to better characterize patients and monitor disease severity and progression, as well as response to treatment, during drug development,” said Umansky.
