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DiamiR Wins $3.9M in NIH Funding for Neurological Disease Diagnostic Development

NEW YORK — DiamiR said on Thursday that it has been awarded nearly $3.9 million in grant funding from the National Institutes of Health to support the development of the company's microRNA diagnostics for mild cognitive impairment (MCI), Alzheimer's disease, and the rare neurological disorder Rett syndrome.

The first grant, a Commercialization Readiness Pilot award worth about $3.4 million over the next two and a half years, supports DiamiR's development of its CogniMir lab-developed test, which analyzes 24 brain-enriched and inflammation-associated miRNAs in blood plasma for the detection of Alzheimer's disease and MCI.

In the grant's abstract, DiamiR said that it has shown that miRNAs can diagnose MCI with 95 percent accuracy, differentiate Alzheimer's disease from other neurodegenerative diseases with around 80 percent accuracy, and identify cognitively normal individuals who will later progress to MCI with 75 percent accuracy.

With the funding, the company will work with Interpace Diagnostics to finalize CogniMir's protocol for the clinical setting and implement the test in a CLIA-compliant lab. Following analytical validation, DiamiR intends to conduct a clinical study to assess the test's performance among 15,000 to 20,000 geographically diverse elderly subjects, with a potential market launch thereafter, according to the grant's abstract.

The second grant is worth $498,572 over a year and a half and will be used to assess the feasibility of differentiating Rett syndrome from age-matched controls by analyzing plasma levels of 38 miRNAs that are enriched in organs and tissues affected by the condition including the brain, liver, lung, and muscle. DiamiR will also determine whether circulating miRNAs can be used to predict disease severity and monitor disease progression, according to the grant's abstract.

The Monmouth Junction, New Jersey-based company said that it will initially develop a Rett syndrome assay for clinical trial use and, later, as an in vitro diagnostic.

"We expect the CLIA-compliant lab-developed tests we are developing will be used initially to better define target patient groups in clinical trials, and later in broader clinical practice," DiamiR CEO Kira Sheinerman said in a statement.

About a year ago, DiamiR received a $492,000 grant from the Alzheimer's Drug Discovery Foundation to investigate the use of miRNAs as biomarkers of neurodegeneration. The firm has also received a number of other NIH grants in recent years including a $345,000 award last September for CogniMir development.