Neurodiagnostics, LLC New Alzheimer’s Assay Granted Breakthrough Device Designation By U.S. Food And Drug Administration

DISCERN™ is the most accurate, least invasive and most cost effective test for identifying Alzheimer’s Disease

(Rockville, MD) October 15, 2018 – NeuroDiagnostics, LLC, a privately held neurological diagnostics company, announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation to NeuroDiagnostics’ DISCERNTM multiple biomarker test for Alzheimer’s Disease. If approved, this test could be the first FDA-approved test utilizing multiple biomarkers for identifying Alzheimer’s Disease and differentiating Alzheimer’s Disease from other dementias.

The Breakthrough Device Program is reserved for breakthrough technologies “that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.” Under the Breakthrough Device Program, the FDA works with device sponsors to reduce the time and cost of the approval decision by assigning an FDA Review Team to the Breakthrough Device and providing interactive and timely communication with the sponsor throughout the review process.

The DISCERNTM Alzheimer’s disease test is the result of more than a decade of research and clinical studies conducted by the Blanchette Rockefeller Neuroscience Institute, now the West Virginia University Rockefeller Neuroscience Institute, utilizing clinically obtained patient samples provided by multiple university hospital centers, including Johns Hopkins University and Marshall University (as originally reported by Khan T, Alkon D, 2010, PNAS, and Chirila F, Khan T, Alkon D. 2013, J. Alzheimer’s disease).

The DISCERNTM test is comprised of three novel proprietary biomarkers, each of which independently identifies and differentiates Alzheimer’s Disease. The test requires only a small skin sample taken at the healthcare provider’s office, much like a routine blood draw.

NeuroDiagnostics’ biomarkers focus on the molecular cascades that are critical in the formation of synaptic networks.

Dr. Daniel Alkon, the Principal Investigator in the clinical trials and co-inventor of DISCERNTM noted that “there has been a critical, unmet need for an accurate and simple test for Alzheimer’s disease. Existing methods to identify Alzheimer’s Disease have limited accuracy, are expensive, and often invasive; those tests that require lumbar spinal tap are frequently avoided by many patients. Until now, a significant number of patients with dementia go undiagnosed, or worse, misdiagnosed. Each of the NeuroDiagnostics biomarkers independently has been found to show high sensitivity and specificity – in both detecting and differentiating AD from other dementias – as confirmed by autopsy validation.”


About Alzheimer’s Disease 

Alzheimer’s disease is a degenerative brain disease and the most common cause of dementia. Dementia is a syndrome – a group of symptoms – that has a number of causes. The characteristic symptoms of dementia are difficulties with memory, language, problem-solving and other cognitive skills that affect a person’s ability to perform everyday activities. These difficulties are eventually followed by impairment of abilities to carry out basic bodily functions such as walking and swallowing. Such symptoms occur because nerve cells (neurons) and the connections between neurons – called synapses – are destroyed in the brains of Alzheimer’s patients. People in the final stages of the disease are bed-bound and require around-the-clock care. Alzheimer’s disease is ultimately fatal.

An estimated 5.7 million Americans of all ages are living with Alzheimer’s disease in 2018. By 2025, the number of people age 65 and older with Alzheimer’s dementia is projected to reach 7.1 million — almost a 29 percent increase from the 5.5 million age 65 and older affected in 2018.

The costs of health care and long-term care for individuals with Alzheimer’s or other dementias are substantial, and dementia is one of the costliest conditions to society. Total payments in 2018 (in 2018 dollars) for all individuals with Alzheimer’s or other dementias are estimated at $277 billion. The Association noted the enormous cost savings, both financial and emotional, that can be achieved with an accurate diagnosis even in the absence of a therapeutic. See the SPECIAL REPORT starting on page 58 of The Alzheimer’s Association in its 2018 Alzheimer’s Disease Facts and Figures Report, a statistical resource for U.S. data related to Alzheimer’s disease.

Because Alzheimer’s disease is underdiagnosed and underreported, a large portion of Americans with Alzheimer’s may not know they have it.

Alzheimer’s disease is officially listed as the sixth-leading cause of death in the United States. It is the fifth leading cause of death for those age 65 and older. However, it may cause even more deaths than official sources recognize. Alzheimer’s disease is also a leading cause of disability and poor health (morbidity). Before a person with Alzheimer’s disease dies, he or she lives through years of morbidity as the disease progresses.

About NeuroDiagnostics, LLC

NeuroDiagnostics, LLC is privately held company focused on the research, development and commercialization of diagnostics for neurological disorders and conditions. NeuroDiagnostics’ laboratory in Rockville, MD is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing.