Diamir granted EU patent for use of microRNAs toward ALS diagnosis

Company now owns 52 patents worldwide that cover miRNA analysis

Esteban Dominguez Cerezo, MS avatar

by Esteban Dominguez Cerezo, MS |

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Diamir Biosciences has received a patent in the European Union that covers the use of microRNAs (miRNAs), that is, small noncoding RNA molecules that modulate gene activity, as biomarkers for diagnosing amyotrophic lateral sclerosis (ALS).

The patent, “Methods of using miRNAs from bodily fluids for detection and differentiation of neurodegenerative diseases,” was registered by the European Patent Office under the number 3433381. It’s set to expire in March 2037. With it, Diamir now owns 52 patents worldwide that cover the use of miRNA analyses in bodily fluids for early disease detection, differential diagnosis, and monitoring disease and aging across a range of conditions.

“Allowance of this new patent by the European Patent Office further strengthens DiamiR’s global [intellectual property] portfolio focused on early detection, prediction of progression, and monitoring of brain health and other conditions,” Samuil Umansky, PhD, chief scientific officer at Diamir, said in a company press release.

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miRNAs aid in reaching ‘disease signature’

Because there’s no specific test for ALS and the disease shares symptoms with other neurological diseases, confirming an ALS diagnosis can be a long process, and is generally based on monitoring symptom progression along with tests to exclude other diseases.

To address this, Diamir has been working on technology that examines levels of certain miRNAs in blood samples or other bodily fluids to better diagnose and monitor a given condition.

MicroRNAs are small RNA molecules that regulate gene activity by binding to messenger RNA, the intermediate molecules produced when genes are read to make a protein and preventing them from being translated into a protein. This can influence the synthesis of certain proteins and modify some cellular functions.

Depending on the disease, levels of diverse miRNAs can be significantly different in patients, creating a specific disease signature. These “signature” biomarkers are useful to differentiate people with a given condition from healthy people, discriminate one disease from similar conditions, or even monitor patients for disease severity levels and their response to treatment. Such a biomarker signature is especially beneficial if the molecules can be detected in a minimally invasive manner, like a simple blood or urine test.

Diamir has been trying to identify combinations of different disease-associated miRNAs that might 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 worked 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 main objective is to provide researchers and clinicians with minimally invasive, accurate molecular solutions for better characterization of patients and monitoring disease severity and progression as well as response to treatment during drug development,” Umansky said.