DiamiR Receives Patent Allowance for Rett MicroRNA Biomarker

The United States Patent and Trademark Office (USPTO) has issued an allowance for a patent submitted by DiamiR for methods the company developed that use microRNA (miRNA) as biomarkers of Rett syndrome and other neurodevelopmental diseases. 

Notices of Allowance are issued by the USPTO when it believes that an invention qualifies for a patent.

DamiR’s approaches are based on targeted analysis of miRNAs that have been found to be highly produced in the brain and detectable by non-invasive blood tests. miRNAs are short RNAs that regulate gene expression, or activity, by binding to target RNA sequences.

“Allowance of this key new patent by the USPTO further strengthens DiamiR’s global IP [intellectual property] portfolio focused on early detection, differential diagnosis, prediction of progression, and monitoring of brain health and other conditions,” Samuil Umansky, MD, PhD, president and chief scientific officer of DiamiR, said in a press release. 

The identification of Rett syndrome biomarkers could help facilitate the tracking of disease severity over time, as well as aid in monitoring the effectiveness of treatments in clinical trials, researchers said.

“In DiamiR’s ongoing clinical biomarker program for Rett syndrome, our main objective is to provide researchers and clinicians with minimally invasive, accurate molecular solutions for evaluating and monitoring disease severity and progression as well as response to treatment during drug development,” Umansky said.

Defects in the MECP2 gene, the chief cause of Rett, have previously been associated with altered levels of miRNAs in the brains of mice.

Last year, the National Institute for Neurological Disorders and Stroke, a division of the National Institutes of Health, awarded a one-and-a-half-year grant of almost $500,000 to DiamiR for its research investigating potential Rett biomarkers. 

That grant was awarded following positive results from a previous study that used a mouse model of Rett syndrome and blood samples from Rett patients. That study found altered levels of specific miRNAs that are highly expressed in the brain and detectable in the blood, making them promising new biomarkers of the disease. 

The miRNAs identified by the DiamiR Rett syndrome biomarker program were able to distinguish Rett patients from healthy individuals (controls) with 85% to 100% sensitivity. When expressed in certain combinations, the miRNAs were associated with specific Rett symptoms and signs such as seizures, walking problems, or abnormal cholesterol levels.