June 7, 2023

June as Alzheimer’s & Brain Awareness Month Raises Importance of Early Diagnosis

SYNAPS Dx (SDx) is pleased to join the Alzheimer’s Association along with many other health organizations in recognizing June as Alzheimer’s & Brain Awareness Month. This annual awareness month shines a light on brain disorders, including Alzheimer’s disease and mixed dementias, as a major public health issue to further the study of Alzheimer’s and raise awareness of the value of an accurate, early diagnosis of the disease.

SDx continues to share the importance of an early and accurate Alzheimer’s diagnosis with the availability and reimbursement for DISCERN™, the first autopsy-validated, highly accurate, minimally invasive skin test to identify the disease in people recently diagnosed with dementia, even when they have mixed dementia. The DISCERN diagnostic test assesses factors closely related to the formation of synaptic connections in the brain as well as the formation of amyloid plaque and abnormal tau. In clinical studies, DISCERN has demonstrated over 95% sensitivity and specificity and is the only autopsy-validated skin test for AD.

DISCERN Addresses High Cost of Alzheimer’s in the United States

The economic burden of Alzheimer’s in the US is projected to increase to $1 trillion by 2050.

This cost is partly made up of current diagnostic pathways such as expensive MRI, cerebrospinal fluid punctures and positron emission tomography (PET) tests used to help determine in patients may have AD. These tests are often invasive and expensive with pricing between $1,300 – $3,000. Costs could be even higher considering repeat testing for patients who have received a misdiagnosis, a common problem in the current diagnostic pathway.

Now that the Alzheimer’s community is seeing treatments with FDA approval, the high costs of drugs like Leqembi, which is priced at $26,500, will also have to be examined.

In addition to these considerable costs, the United States has also estimated the price of unpaid care provided by friends and family to people with Alzheimer’s disease and other dementias. Over 11 million people provided more than 16 billion hours of unpaid care in 2021, valued at $272 billion.

DISCERN notably can save nearly $5 million in just three years for a Medicare Advantage plan with one million beneficiaries. It is estimated that the addition of anti-amyloid therapies will add $10B by 2030 in direct drug costs and $.5B for monitoring with advanced imaging. When considering these additional costs, the savings from improved diagnostic accuracy from access to DISCERN among the community treaters will likely be even greater.

Given the complexity of this disease, getting an accurate diagnosis is critical for ensuring that people get the right treatment as soon as possible, to mitigate the rising costs of Alzheimer’s.

Understanding the Value of Early Diagnosis

Timing is everything with patients recently diagnosed with dementia. An early diagnosis of Alzheimer’s disease provides those with a greater impact on slowing cognitive decline, as well as more time spent with their loved ones. With recent developments in drugs designed to slow the progression of the disease, the earlier an Alzheimer’s diagnosis is received, the greater the chance of benefiting from the treatment.

A Closer Look at DISCERN

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 the first autopsy-validated test to demonstrate the Morphometric Imaging (MI) biomarker specificity and sensitivity of 100% (p<.001) when compared to the NIH Gold Standard criteria for distinguishing the disease from non-Alzheimer’s disease patients and demonstrating the burden an Alzheimer’s diagnosis has on physicians. Getting an accurate Alzheimer’s diagnosis is important because treatment options for patients are specific and distinct compared to treatments for patients with other forms of non-Alzheimer’s dementia.

The 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. Complimentary to the MI assay, the protein kinase C (PKCε) assay includes fibroblasts from the skin biopsy that are cultured and analyzed using the ELISA 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.  

Contact SYNAPS Dx to learn more about Alzheimer’s diagnoses and the science behind DISCERN.

* 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.