SYNAPS Dx (SDx), a privately held company focused on the research, development and commercialization of a diagnostic test for Alzheimer’s disease (AD), recently participated at BRAINWeek 2023 with the release of compelling data on the performance of the Morphometric Imaging (MI) assay of the DISCERN test and the results of a clinical utility study demonstrating the role of DISCERN in informed physician decision-making. DISCERN is an autopsy-validated, minimally invasive diagnostic skin test that 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.
Frank Amato, CEO and president, SDx, says, “Results from our autopsy-validated clinical study demonstrate that the MI assay accurately identified AD in people diagnosed with dementia, even in the presence of other co-morbid pathologies at autopsy.”
Amato further explains the results support the conclusion that the MI assay accurately identifies AD, even in the presence of mixed dementia, adding, “Over 50% of people with AD also have other pathologies of dementia, the presence of which can complicate diagnosis with the current diagnostic pathway and may adversely impact treatment outcomes.”
MI is the primary assay in DISCERN, correlating skin cell abnormalities with dementia and the presence of AD pathology in the brain. AD fibroblast cells form larger aggregates in contrast to non-AD dementia (non-ADD) or non-dementia control (NDC) samples, which formed smaller and more numerous aggregates. These findings were collected using a double-blind protocol for demented patients over the age of 55 and eventually confirmed through an autopsy study.
The clinical utility study from a sample of 402 primary care physicians (PCPs) including 250 PCPs, 102 neurologists and 50 geriatricians demonstrated that 90% physicians would routinely use the results of DISCERN. Clinicians indicated that a DISCERN result was the most important attribute in the decision-making process for medication prescribing or other treatment, indicating that with a positive DISCERN test, they were six times more likely to diagnose and four times as likely to prescribe the new anti-amyloid drugs indicated for AD.
Amato points to the studies as further confirmation of the test’s value as the most promising breakthrough for early diagnosis of AD, saying, “DISCERN is an important breakthrough for the AD community. While there are tests for identifying the presence of amyloid, only DISCERN has demonstrated >95% sensitivity and specificity to identify AD itself in people living with dementia or mixed dementia. Administered as a single skin biopsy by a clinician, DISCERN is readily accessible in the community setting, informing care plans that can improve outcomes, reduce costs, and improve patient satisfaction.”
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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