The Longest Day of the year, or summer solstice, happens on June 21, 2023. For this reason, the Alzheimer’s Association chose this day to raise awareness across the world about fighting the darkness of Alzheimer’s disease.
This is an opportunity to halt the increased rate of Alzheimer’s misdiagnosis and to shine a light on the physician burden of managing the Alzheimer’s journey for patients. With over half of symptomatic patients misdiagnosed with Alzheimer’s in the generalist setting and 25%-30% misdiagnosed in specialty memory clinics, physicians require objective, less invasive diagnostic tests to inform a definitive diagnosis of Alzheimer’s. Many recognize that the ability to differentiate earlier between Alzheimer’s and another form of dementia is essential – particularly to support prescribing decisions for newly approved, expensive drugs that have associated adverse events for patients.
Important Role of DISCERN™
Anticipating these challenges, SDx developed DISCERN™ to provide an early and accurate Alzheimer’s disease diagnosis. With >95% accuracy in clinical trials, DISCERN answers a critically important unmet medical need for an accurate diagnosis in the primary care setting.
DISCERN™ is the first autopsy-validated, highly accurate, minimally invasive skin test informing the diagnosis of Alzheimer’s versus other forms of non-Alzheimer’s disease dementias and those with the disease and other degenerative pathologies. The DISCERN test assesses the factors directly related to the formation of synaptic connections in the brain impacting loss of memory and cognition in people living with AD as well as regulators of amyloid plaque and tau formation, hallmarks of AD at autopsy.
The test is the first of its kind to earn Proprietary Laboratory Analyses (PLA) Codes 206U and 207U. Medicare-Fee-for-Service has reimbursed the cost of the DISCERN exam. Getting an accurate diagnosis is important because treatment options for Alzheimer’s patients are specific and distinct compared to treatments for patients with other forms of non-Alzheimer’s disease dementia.
Physicians Opt for DISCERN
A study of 402 physicians indicates DISCERN is well-positioned to reduce or replace costly and often invasive diagnostic tests, including positron emission tomography (PET) scans, brain MRI, CT scans and cerebrospinal fluid punctures. The following study found a significant level of need:
- 8 out of 11 physicians underscore the utility of an objective, less invasive diagnostic test
- 7 out of 12 cited the need for a test that can differentiate Alzheimer’s disease from other forms of dementia
- 8 out of 12 physicians were likely to order the DISCERN test to diagnose patients with suspected Alzheimer’s
DISCERN meets the unmet need for a diagnostic tool that supports early detection and a simple test that is widely accessible and affordable.
DISCERN gives patients and families the answers they need and supports establishment of authorization protocols by payers for prescribing and reimbursing treatment. It also helps pharmaceutical companies identify appropriate clinical trial participants and may provide additional metrics to evaluate treatment response.
Learn more about Alzheimer’s diagnostics and the DISCERN test.
* 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.