NIA Small Business Showcase: DiamiR
More than 5.5 million people in the United States have Alzheimer’s disease (AD), with annual medical and long-term care costs estimated at hundreds of billions and no disease-modifying treatments currently available. AD begins with a prolonged asymptomatic stage, followed by gradually developing mild cognitive impairment (MCI), so minimally invasive solutions for early detection and differential diagnosis are needed to facilitate enrollment of participants into clinical trials, enable monitoring of disease progression and treatment, and better plan clinical care.
DiamiR is a privately held molecular diagnostics company developing blood-based tests for early detection and monitoring of brain and synaptic health, including MCI and AD. Its proprietary technology is based on targeted selection and quantitative analysis of brain-enriched and inflammation-associated microRNA biomarkers in plasma. The first test in late stages of development is CogniMIR™, for early detection and prediction of progression of preclinical AD and MCI. CogniMIR™ combines quantitative measurement of microRNA levels in blood plasma and a classifier algorithm, with positive results indicating pathology and the need for additional testing and/or treatment.
The global neurological biomarkers market for AD generated $2.6 billion in revenue in 2017 and is expected to reach $6.1 billion by 2025. The aging population is a major factor in the drive for AD diagnostic tests, as is the rapid adoption of neurological biomarkers in drug development. The Foresight report on DiamiR technology estimated the U.S. market for CogniMIR™ at $850 million and the global market at $2.6 billion annually.
In recent years, significant progress has been made with neuroimaging and cerebrospinal fluid biomarkers. However, their high cost and invasiveness, as well as their limited availability in the community medical centers where blood-based tests might provide a viable solution for initial diagnostic assessment, make these techniques impractical for primary testing. With multiple companies worldwide developing blood-based molecular assays for the early detection of AD, a DiamiR’s proprietary technology is unique in that it is based on targeted analysis of microRNAs enriched in specific brain regions, present in synapses, and detectable in plasma. MicroRNAs are dynamic analytes that inform about real-time expression status. They are easy to multiplex, allowing combinations of several microRNAs reflective of underlying pathophysiological processes in the same classifier.
- Platform technology for early detection of pathology based on analysis of organ-enriched microRNAs in plasma
- Lead program focused on detection, differential diagnosis, and prognosis of MCI and AD
- 24-microRNA classifier
- Achieving differentiation between pathology and control of over 90% accuracy
- Analysis of more than 1,000 plasma samples
- Multiple peer-reviewed publications and oral/poster presentations at the AD/PD™ conference, Alzheimer’s Association International Conference, Clinical Trials on Alzheimer’s Disease Congress, and BIO events
- Accumulating a knowledge base on CogniMIR™ testing in large heterogeneous cohorts
- Establishing microRNA signatures for other neurodegenerative diseases and brain health conditions
- More than 30 patents, comprising three patent families, issued in the United States, the European Union, Asia, and elsewhere
- Research partnerships with key opinion leaders, pharmaceutical companies, and disease foundations
- $7 million in highly competitive grants from the NIH/NIA, the Michael J. Fox Foundation, and the Alzheimer’s Drug Discovery Foundation (ADDF)
- Building a strong team and advisory board
- First half of 2022: completing the validation of CogniMIR™
- Second half of 2022: supporting the launch of CogniMIR™
- Building additional biopharmaceutical partnerships
DiamiR’s work has been supported by private capital, biopharmaceutical revenue, and approximately $7 million in highly competitive grants. In November 2019, DiamiR announced $492,000 in funding from the ADDF Diagnostics Accelerator, a fund set up in collaboration with Bill Gates and other philanthropic partners. DiamiR’s business model is based on a dual-revenue model: biopharmaceutical services and diagnostics.
DiamiR anticipates $2 million to $4 million toward CogniMIR™ rollout and advancement of other brain health and aging-related programs in the pipeline.
DiamiR owns worldwide rights to its technology and product candidates in development, including over 30 patents, comprising three patent families, issued since 2014. With four new patent families covering DiamiR’s inventions and further applications of the technology in prosecution, the DiamiR team continues to work on building a solid intellectual property portfolio.
Product Development and Regulatory Strategy
Short-term business objectives include the development of CogniMIR™ as a laboratory developed test (LDT) to be run in a Clinical Laboratory Improvement Amendments (CLIA) laboratory. CogniMIR™ will initially be introduced to assist biopharmaceutical companies with active drug development programs in screening patients for enrollment into MCI/AD clinical studies. After development of a large database of heterogeneous samples and comprehensive clinical evaluation of CogniMIR™, DiamiR will start marketing the test to neurologists and gerontologists for use in the broader population.
The initial commercial application is in screening and monitoring of early-stage patients for AD-focused registries and clinical trials evaluating therapeutic interventions aiming to slow down, halt, or potentially reverse AD progression. Following use as a CLIA test, the assay will be submitted as in vitro diagnostics (IVD) for approval by the U.S. Food and Drug Administration.
11 Deer Park Drive, Suite 102G
Monmouth Junction, NJ 08852
- Chief Executive Officer: Kira Sheinerman, Ph.D., M.B.A.
- Chief Scientific Officer: Samuil Umansky, M.D., Ph.D., Dr.Sci.
- Director of Assay Development: Michael Kiefer, Ph.D.
- Head of Informatics: Vladimir Tsivinsky, Ph.D.
- Strategic Development: Jennifer Seibert, M.Sc., M.B.A.
Point of Contact:
Kira Sheinerman, Ph.D., M.B.A.
Email Kira Sheinerman
Conference Selected for Showcase: Digital RESI (June 2020)