Synaptogenix Inc (SNPX)

[runncoach]

More than interesting. Synaptic biomarkers anyone?
https://markets.businessinsider.com/news/stocks/neurodiagnostics-llc-new-alzheimer-s-assay-granted-breakthrough-device-designation-by-u-s-food-and-drug-administration-1027618446

NeuroDiagnostics, LLC New Alzheimer's Assay Granted Breakthrough Device Designation by U.S. Food and Drug Administration
PRESS RELEASE PR Newswire
Oct. 15, 2018, 05:45 PM
ROCKVILLE, Md., Oct. 15, 2018 /PRNewswire/ -- 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."