An estimated 6.7 million Americans are living with Alzheimer’s disease, a highly complex disease that is impacting individuals and families and presenting diagnostic challenges to physicians. An accurate diagnosis is critical for ensuring that people get the right treatment as soon as possible.
The Importance of Early Diagnosis
Being able to distinguish between Alzheimer’s and other forms of dementia is extremely important in slowing down cognitive decline as well as saving money on the necessary tests and treatments. Amato discusses how accurate early diagnosis of Alzheimer’s is critical to determining the right path of care which can lead to the slowing down of cognitive impairment and leading to improved quality of life.
With an accurate and early diagnosis, the appropriate drugs will be prescribed or lifestyle changes will be recommended to help patients support their brain health. Amato goes on to explain that without an accurate diagnosis, an individual may be prescribed drugs that not only carry significant safety concerns and burdensome treatment and monitoring requirements, but are also expensive and may not even help to improve cognition.
Amato points out that with Alzheimer’s, people don’t have the luxury to go through a trial and error of drugs that may not work: over a three-year period a person could lose major cognitive function. An accurate Alzheimer’s diagnosis opens the door for other treatment options that are patient-specific and distinct compared to treatments for patients with other forms of non-Alzheimer’s dementia.
A Closer Look at DISCERN™
In this podcast, Amato highlights a diagnostic pathway forward for the Alzheimer’s community, including an easily accessible and accurate DISCERN™ test for Alzheimer’s disease. DISCERN is the first Alzheimer’s Disease test of its kind to earn Proprietary Laboratory Analyses (PLA) Codes 206U and 207U from the Centers for Medicare and Medicaid Services (CMS).
DISCERN™ is comprised of three different assays that assess several critical factors directly related to Alzheimer’s disease that regulate memory, the formation of synaptic connections among neurons, the levels of amyloid plaques and levels of neurofibrillary tangles in the brain. The DISCERN™ test is autopsy-validated versus the NIH Gold Standard definition of Alzheimer’s Disease.
The established relationship between Alzheimer’s Disease and the skin provides unique positioning for DISCERN which requires a minimally invasive, 3mm skin punch biopsy. Physicians in the primary care community and neurology settings place high value on this simplified, cost-effective diagnostic pathway to identify Alzheimer’s Disease. Given the high cost and risk/benefit drug profiles, accurate prescribing is more important than ever.
The Morphometric Imaging (MI) assay is based on measuring an ensemble of multiple factors such as inflammation, synaptic growth and neuronal death that can be detected in skin fibroblasts. Complementary to the MI assay, the protein kinase C (PKCε) assay includes fibroblasts from the skin biopsy that are cultured and analyzed using enzyme-linked immunosorbent assays (ELISAs) to measure PKCε levels in relation to Aβ exposure in the brain. The AD-biomarker index also composes one of the three assays and tests skin fibroblasts from biopsies to culture to confluency.
* The DISCERN™ test was developed and its performance characteristics determined by NeuroDiagnostics Inc, dba Synaps Dx. It has not been cleared or approved by the U.S. Food and Drug Administration. NeuroDiagnostics, Inc. is regulated under the Clinical Laboratory Improvement Amendments (CLIA) as an accredited laboratory to perform high complexity clinical testing. The test is intended for patients with dementia. Test results should be interpreted in conjunction with other laboratory and clinical data available to the clinician. All rights reserved.