SYNAPS Dx (SDx) a privately held company focused on the research, development and commercialization of a diagnostic test for Alzheimer’s disease (AD), recognizes the historic Food and Drug Administration (FDA) approval of Leqembi, the first drug shown to slow the progression of AD.

By adding the DISCERN™ test in community practices, healthcare practitioners will have access to the only autopsy-validated accurate skin test to identify AD, one of the first steps in diagnosing AD among people recently diagnosed with the disease. Pursuant to the Leqembi label, once AD is identified, then an assessment of amyloid positivity can be performed in determining if the drug is appropriate. In clinical utility studies, clinicians were four times more likely to prescribe drugs like Leqembi with a positive DISCERN test than if the test was negative.

Frank Amato, CEO and president, SDx, says, “FDA approval of Leqembi is a step forward to help patients and families in their fight against this debilitating condition that impacts millions of Americans. The DISCERN test helps prescribers and patients to weigh the risks and benefits of taking the drug given the significant safety considerations, including amyloid-related imaging abnormalities (ARIA) and potential brain bleeding. Given these risks, diagnostic certainty is critical to ensure that AD is the cause of symptoms. Without access to cost-effective diagnostic tools, data suggest that currently, 50-70% of symptomatic patients are misdiagnosed with AD in the generalist setting.”

The DISCERN diagnostic test assesses factors closely related to the formation of synaptic connections in the brain as well as the formation of amyloid plaque and abnormal tau. Synaptic connections are lost as cognitive functions decline, even early in AD. Amyloid plaques and abnormal tau are the pathologic hallmarks in the brain at autopsy that, together with dementia, definitively identify those patients with AD.

The established relationship between AD and the skin provides unique positioning for DISCERN which requires a minimally invasive, 3mm skin punch biopsy. Physicians in the primary care community and neurology settings place high value on this simplified, cost-effective diagnostic pathway to identify AD. Given the high cost and risk/benefit drug profiles, accurate prescribing is more important than ever.

“AD is complex but DISCERN resolves the diagnostic dilemma, enabling physicians to make a more definitive diagnosis,” continues Amato. “Early intervention is clearly the key to success, but the question is what is the best intervention? We strongly recommend on first focusing on modifiable risk factors before adding drugs with significant safety and economic burdens to patients, practitioners and the overall healthcare system.”

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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