The U.S. Food and Drug Administration has granted Breakthrough Device designation to DISCERN, a biomarker test for Alzheimer’s. The test was developed using blood and tissue samples that were monitored and evaluated by WVU’s Rockefeller Neurosciences Institute.
If the test gains full approval, it will be the first FDA-approved test using multiple biomarkers to identify Alzheimer’s Disease – helping differentiate the disease from other dementias.
DISCERN is comprised of three novel proprietary biomarkers, each of which independently identifies and differentiates Alzheimer’s Disease. In 2016, WVU licensed out to Neurodiagnostics, a Delaware-based biotech company the exclusive rights to develop and commercialize the three neurological biomarkers. The test requires only a small skin sample taken at the healthcare provider’s office, much like a routine blood draw.
The FDA’s Breakthrough Device Program is reserved for technologies that offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program reduces the time and cost of the FDA’s approval decision.
DISCERN is the result of more than a decade of research and clinical studies conducted by the WVU Rockefeller Neuroscience Institute (formerly the Blanchette Rockefeller Neuroscience Institute), utilizing clinically obtained patient samples provided by multiple university hospital centers, including Johns Hopkins and Marshall.
For more information on RNI, visit wvumedicine.org/rni.