Early, Accurate Diagnosis of Alzheimer’s Disease with DISCERN™ Test is Critical for Identifying Appropriate Patients for LEQEMBI™

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SYNAPS Dx (SDx), a privately held company focused on the research, development and commercialization of a diagnostic test for Alzheimer’s disease (AD), emphasizes that FDA approval of LEQEMBI™ (lecanemab) as a new drug for AD signals a turning point for clinicians, payers and all stakeholders in the benefits community. Adding the DISCERN™ test to their armory of diagnostic weapons in primary care helps prepare the health system for the introduction of this new drug. Unlike other diagnostic tests for AD, DISCERN is autopsy-validated to identify AD in people recently diagnosed with dementia, is readily accessible as well as time- and cost-effective in the primary care setting.

Frank Amato, CEO and president, SDx, says, “FDA approval of LEQEMBI is a great first step forward to help patients and families in their fight against this debilitating condition that impacts millions of Americans. Cost-effectively identifying appropriate candidates for treatment with these drugs will be key to setting expectations of patients, providers and budget impact planning for payers. Without access to cost-effective diagnostic tools in the primary care setting, data suggest that currently, 50-70% of symptomatic patients are misdiagnosed with AD.”

LEQEMBI, an amyloid beta-directed antibody indicated for the treatment of AD and its mechanism of action to clear amyloid beta, requires confirmation of the presence of amyloid to accurately diagnose people with AD and understand if the patient may be an appropriate candidate. As noted in the indication for LEQEMBI, the first question to answer is if AD is present.

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Media Contact : Caroline Chambers

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