SYNAPS Dx (SDx), a privately held company focused on the research, development and commercialization of a diagnostic test for Alzheimer’s disease (AD), is pleased to announce the release of its two-part white paper, “Accurately Diagnosing Alzheimer’s Disease: Shortcomings of Blood Biomarkers and Need for Definitive, Non-invasive Diagnostic Testing.” This paper analyzes the efficacy of blood-based markers (BBMs), pathways forward for accurate diagnoses, new disease modifying therapies (DMTs) and supports all stakeholders in the healthcare ecosystem.

“Blood biomarkers show promise by indicating biological changes that can indicate presence or absence of a disease, or the likelihood of later developing a disease based on surrogate markers of the underlying disease,” says Dr. Daniel Alkon, chief scientific advisor, SDx. “While BBMs for AD show promise and have a role to play with the advent of amyloid targeted drugs, the Alzheimer’s Association states in detail that further research is needed before widespread use of BBMs for AD can be recommended and advise BBMs should not yet be used as primary endpoints in pivotal trials. While BBMs are sensitive, they do not have high specificity as validated with brain pathology at autopsy.”

The need for an accurate and readily accessible diagnostic is high, with 50% to 70% of symptomatic AD patients not correctly diagnosed in primary care. This is due to lack of routine cognitive screenings and accurate, accessible and time- and cost-effective diagnostic tools. The problem is exacerbated in early stages of the disease in patients without dementia who experience cognitive decline or mild cognitive impairment (MCI).

Misdiagnosis leads to unnecessary care-seeking and costly investigations due to diagnostic uncertainty. It is common for the symptoms of AD to be confused with a number of other medical conditions, some of which may be reversible, such as Lyme disease, vitamin deficiencies, thyroid issues, depression, drug interactions and other forms of dementia.

“SDx has demonstrated that clinicians require an accurate, readily accessible and less invasive diagnostic test to inform a definitive diagnosis of AD itself,” says Frank Amato, CEO and president, SDx. “While BBMs have the potential to help clinicians screen for the presence of amyloid plaque or tau, hallmarks of AD, they do not diagnose MCI or early AD dementia with high accuracy. The DISCERN test is autopsy-validated to identify AD in people recently diagnosed with dementia and demonstrated >95% sensitivity and specificity for identifying AD versus the NIH Gold Standard definition for AD – dementia in life and the presence of plaque/tau upon autopsy.”

About SYNAPS Dx

SYNAPS Dx is a privately held company focused on the research, development and commercialization of a diagnostic test for Alzheimer’s disease (AD). The Company offers DISCERN™, the first highly accurate, minimally invasive test supporting a clinician’s definitive diagnosis of AD versus other forms of dementia, even in people recently diagnosed with dementia. SYNAPS Dx’s laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing. Physicians and patients seeking more information can visit https://discerntest.com/. For more information on the Company, visit https://www.synapsdx.com/. Contact: info@synapsdx.com.

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