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 publication of “Morphometric imaging biomarker identifies Alzheimer's disease even among mixed dementia patients” in Scientific Reports.
“Up until now, there have been no autopsy-validated tests shown to accurately identify AD in the presence of mixed dementia, or dementia from one or more co-existing causes, affecting over half of patients diagnosed with AD,” says Dr. Daniel Alkon, chief scientific advisor, SDx and corresponding author of the paper. “We are pleased to share this groundbreaking data showing that the MI biomarker demonstrated specificity and sensitivity of 100% (p<.001) when compared to the NIH Gold Standard criteria for AD in distinguishing AD from non-AD patients, even in the presence of other co-morbid pathologies.”
Dr. Alkon further explains that DISCERN™ is a CLIA-certified diagnostic skin test comprised of three assays that assess several factors related to synaptic and neuronal loss that impact cognitive loss, as well as regulators of amyloid plaque and neurofibrillary tangles in the brain. The test is autopsy-validated to inform a definitive diagnosis of AD, even in people recently diagnosed with dementia. The DISCERN AD biomarkers also depend on factors that regulate amyloid plaque and tau formation, hallmarks of AD at autopsy.
“DISCERN is an important breakthrough for the AD community because there are currently no other autopsy-validated tests that are highly sensitive and highly specific for identifying AD in people recently diagnosed with dementia or mixed-dementia,” says Frank Amato, CEO and president, SDx. “With expected FDA-approved treatments for AD on the horizon, in addition to determining the presence of amyloid plaques consistent with AD, patients will likely need an accurate AD diagnosis to determine if amyloid targeted drugs are appropriate for them.”
Amato explains that currently, most patients with dementia are managed in primary care where due to the lack of availability of diagnostic tools, more than half are misdiagnosed.
“While blood biomarkers have the potential to help clinicians screen for the presence of amyloid plaque or tau, hallmarks of AD, they do not diagnose mild cognitive impairment (MCI) or early AD dementia with high accuracy,” Dr. Alkon continues. “Well-defined cohorts such as the oldest old individuals can be entirely cognitively normal – i.e. not at all demented – but have abundant amyloid plaques and tau tangles at autopsy.”
“With use of the DISCERN test, which relates to loss of synaptic networks as well as amyloid and tau, primary care clinicians have indicated a greater confidence in the diagnosis of AD, potentially avoiding unnecessary, invasive and expensive diagnostic procedures and identifying patients with AD dementia who are appropriate candidates for treatment,” says Dr. Alkon.
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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