Keeping Pace with Evolving Diagnostic Approaches for Alzheimer’s Disease

An early diagnosis of Alzheimer’s Disease (AD) can help determine if the symptoms a patient is experiencing are truly due to AD or some other conditions that may be treatable. Unfortunately, when it comes to diagnostic tests for AD, considerable confusion has prevailed in the marketplace, often without clarity of the clinical importance of what is being measured. 

Although AD is the most common type of dementia, there are many other kinds, including Lewy body dementia, Huntington’s disease, and Creutzfeldt-Jakob disease. Furthermore, memory loss can be brought on by a myriad of medical issues, including Lyme disease, vitamin deficiencies, thyroid issues, drug interactions and the various forms of dementia. Some of the conditions that are often mistaken for AD can easily be addressed with inexpensive interventions. Without a definitive diagnosis, however, it’s frustrating, expensive and overwhelming for patients and families, providers and payers to know how to proceed in the care journey.

But that is about to change with DISCERN™ by SYNAPS Dx (SDx), the first accurate, minimally invasive test for the definitive diagnosis of Alzheimer’s disease (AD) versus other forms of dementia. Competitive barriers to entry include the SDx strong global IP portfolio and autopsy-validated clinical data, which takes many years to collect and confirms that the test is highly accurate with 95% sensitivity/specificity for diagnosing AD.

Current AD Diagnostics

Diagnosing patients with AD or mild cognitive impairment begins with the patient’s medical history, along with mental status tests and physical and neurological exams. Physicians may utilize additional diagnostic testing modalities to identify patients with AD, including amyloid PET, MRI and CSF-based biomarker testing. In line with the current coverage environment, however, payers note several limitations of these modalities. These limitations are due to the low accuracy or high cost of neuropsychological tests and neuroimaging. 

While the progression and increased severity of symptoms support diagnosis, only autopsy findings provide a definitive method to diagnose AD. What’s more, AD often co-develops with other age-related neurological disorders, such as Parkinson’s disease and strokes.

Promising Diagnostic Breakthrough

Making a clear and early diagnoses of AD is critical and, given the extent that cognitive measures are documented, essential for quality care and addressing the needs of AD patients in a timely manner. To help achieve earlier diagnosis, important first steps are to detect and track cognitive decline by measuring and documenting cognitive function during medical visits. This is also important for inclusion and exclusion criteria in statistical analysis.

DISCERN™ assesses losses of activity of nerve cells in the brain and their ability to form networks and communicate, addressing several of the limitations that payers and healthcare providers identify in existing AD diagnostic tools. 

This test also gives patients and families the answers they need, enables providers to make a conclusive diagnosis, allows payers to establish protocols and prior authorizations for prescribing and reimbursing treatment and helps pharmaceutical companies identify appropriate clinical trial participants. 

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Author: Frank Amato, CEO and President, SYNAPS Dx