SYNAPS Dx Introduces DISCERN™ Test for Accurate Alzheimer's Disease Diagnosis and Informed Coverage Decisions for Leqembi™, Minimizing Patient Risks

Wednesday, July 12, 2023

SDx, a privately held company specializing in the research, development, and commercialization of a diagnostic test for Alzheimer's disease (AD), recognizes the historic approval of Leqembi by the FDA. Leqembi is the first drug proven to slow the progression of AD. The incorporation of the DISCERN™ test in community practices provides healthcare practitioners with an accurate skin test for identifying AD, serving as an essential step in diagnosing recently diagnosed individuals with the disease. Once AD is identified, an assessment of amyloid positivity can be performed to determine the suitability of the drug. Clinical utility studies have demonstrated that clinicians are four times more likely to prescribe drugs like Leqembi if the DISCERN test yields a positive result compared to a negative result.

Frank Amato, CEO and president of SDx, expresses appreciation for the FDA's approval of Leqembi, recognizing its significance in supporting patients and families fighting against this debilitating condition that impacts millions of Americans. The DISCERN test assists prescribers and patients in assessing the risks and benefits of taking the drug, considering important safety considerations such as amyloid-related imaging abnormalities (ARIA) and potential brain bleeding. Given these risks, diagnostic certainty is crucial to ensure that AD is accurately diagnosed and linked to symptoms. Without access to cost-effective diagnostic tools, it is estimated that 50-70% of symptomatic patients are misdiagnosed with AD in generalist settings.

The DISCERN diagnostic test evaluates factors related to the formation of synaptic connections in the brain, as well as the presence of amyloid plaque and abnormal tau. Synaptic connections are progressively lost as cognitive functions decline, even in early stages of AD. Amyloid plaques and abnormal tau are key pathological indicators found during autopsies that definitively identify patients with AD.

The unique positioning of DISCERN, which requires a minimally invasive, 3mm skin punch biopsy, leverages the established relationship between AD and the skin. Primary care physicians and neurologists highly value this simplified and cost-effective diagnostic pathway for identifying AD. Given the high cost and risk/benefit profiles of drugs, accurate prescribing is more important than ever.

Amato emphasizes that DISCERN helps resolve the diagnostic challenges associated with AD, enabling physicians to make a more definitive diagnosis. Early intervention is crucial for success, and it is essential to consider the most effective intervention. Amato strongly recommends focusing on modifiable risk factors before considering drugs with significant safety and economic implications for patients, practitioners, and the healthcare system as a whole.


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