SYNAPS Dx Releases Autopsy-Confirmed Results for DISCERN Alzheimer’s Test MI Biomarker, Accurately Diagnoses Alzheimer’s in Presence of Other Co-Morbid Pathologies

ROCKVILLE, Md.--(BUSINESS WIRE)-- SYNAPS Dx (SDx), a privately held company focused on the research, development and commercialization of a diagnostic test for Alzheimer’s disease (AD), has released data on the performance of the Morphometric Imaging (MI) assay of the DISCERN test at the Alzheimer’s Association International Conference (AAIC), July 31 – Aug. 4, 2022, San Diego. Results from this 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.

Dr. Daniel Alkon, chief scientific advisor, SDx, explains, “Results presented in our study, ‘Autopsy-Confirmed Minimally Invasive Biomarker Identifies Alzheimer’s Disease Even in the Presence of Co-Morbid Pathologies,’ show that when compared to the NIH Gold Standard criteria for AD, the MI biomarker demonstrated specificity and sensitivity of 100% (p<.001) in distinguishing AD from non-AD patients. The MI biomarker correctly diagnosed AD even in the presence of other co-morbid pathologies.”

He says 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™, a 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.

The MI assay correlates 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.

Frank Amato, CEO and president, SDx, adds, “We are bringing an innovative, accurate test to market, one that has the potential to impact patient care planning today and improve outcomes with therapeutic interventions in development.”

He points to the study results as further confirmation of the test’s value as the most promising breakthrough for early diagnosis of AD, saying, “DISCERN is also an important breakthrough for the AD community because while there are approved tests for identifying the presence of amyloid in circulation, there are currently no tests that are as highly sensitive or specific for identifying AD itself, especially in early dementia or in the case of mixed-dementia.”

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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