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NORTHBROOK, Ill. - December 14, 2021 - (Newswire.com)
ADM Diagnostics, Inc. (ADMdx) has received FDA clearance for CorInsights MRI. Using a standard MRI scan, CorInsights MRI provides quantitative information about brain tissue volume for use by radiologists and neurologists, as well as clinical researchers. It has been well established through published studies that brain volumes are often affected by disorders such as Alzheimer's disease and other types of dementia, showing accelerated patterns of tissue volume loss.
ADMdx's proprietary CorInsights MRI software uses a patient's brain MRI scan to accurately measure brain volume in certain brain regions and compares this information to a proprietary and highly curated normative reference database. CorInsights MRI translates these comparisons into a set of images, graphs, and summaries to allow the medical professional to better understand the overall pattern of effect.
To use CorInsights MRI, a standard, reimbursable patient scan is submitted electronically by a medical professional to ADMdx. Proprietary software is used to measure the tissue volume in numerous regions of the brain, and to determine percentiles relative to age- and sex-matched reference values. The analysis is to be completed, and an illustrated patient-specific report returned to the submitter, securely with a same-day turnaround.
Dawn Matthews, CEO, stated, "CorInsights MRI is our first FDA cleared product. It is aimed at providing a significant benefit to patient care. The product focuses on the needs of the radiologist and neurologist, other medical professionals involved in the patient's care, the patient, and their caregiver. ADMdx's development goals* include differentiating dementias, predicting cognitive decline, and measuring treatment effect."
To develop and validate the CorInsights MRI product, ADMdx used scans from its curated database of more than 30,000 well-characterized brain images with associated clinical and biomarker data from public and private sources. An exceptionally high quality, proprietary normative database was developed using 600 scans from persons who were diagnosed to be cognitively normal, negative for amyloid pathology (an abnormal protein in Alzheimer's disease), and negative for a variety of other potential confounding abnormalities, including overt vascular disease as evidenced by white matter lesions, stroke, tumor, normal pressure hydrocephalus, or a history of traumatic brain injury or severe neuropsychiatric illness. In total, more than 1,400 scans from over 1,100 individuals were used in testing of CorInsights MRI.
Validation testing was conducted using patient scans with a broad spectrum of clinical diagnoses, including cognitively normal, Mild Cognitive Impairment, typical and atypical Alzheimer's disease, and non-Alzheimer's dementias. Alzheimer's disease (AD) cases (confirmed for amyloid positivity) included late onset AD, Early Onset AD, Posterior Cortical Atrophy, Logopenic Progressive Aphasia, and Corticobasal Syndrome. Non-Alzheimer's cases included behavioral variant Frontotemporal Dementia (FTD), semantic variant FTD, Nonfluent Primary Progressive Aphasia, Primary Progressive Aphasia (other), amyloid negative Corticobasal Syndrome, vascular disease, moderate to severe white matter disease, and ventricular enlargement. Mild Cognitive Impairment (MCI) cases included early MCI, late MCI, and persons who converted to a clinical diagnosis of dementia at 12 months post-scan.
ADMdx will hold web-based introductions to CorInsights MRI for medical professionals beginning on Jan. 13, 2022, and plans to begin accepting scans by Jan. 25, 2022. For more information please visit the ADMdx website at www.admdx.com.
About ADM Diagnostics, Inc.
ADM Diagnostics, Inc. provides advanced, proprietary brain image analysis products and services that are used in clinical trials of new drugs to treat Alzheimer's disease and other brain disorders. ADMdx has applied its expertise in collaborations with researchers from the Cleveland Clinic, Rockefeller University, Mt. Sinai Icahn School of Medicine, Weill Cornell College of Medicine, The University of Arizona, and other institutions to gain new insights into Alzheimer's disease, Traumatic Brain Injury, and other brain conditions. ADMdx's first FDA cleared product, CorInsights MRI, uses MRI brain scans to provide information for medical professional use in evaluating patients.
*These are future goals and not products. They are not FDA cleared, not commercially available, and not for sale. They are simply future goals of ADMdx.
For information, contact: Gemini Janas, email gjanas@admdx.com
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Original Source: ADM Diagnostics, Inc. Announces Launch of CorInsights® MRI
