SYNAPS Dx’s DISCERN™ Diagnostic Test Supports Payer Coverage and Prescribing Decisions for Lecanemab, Expected Breakthrough Treatment of Alzheimer’s Disease

SYNAPS Dx (SDx), a privately held company focused on the research, development and commercialization of a diagnostic test for Alzheimer’s disease (AD), announces support for the nations’ payers in their coverage and prescribing determinations for the AD drug, lecanemab when it is approved as expected by the FDA. Evidence of the drug’s efficacy with safety observations are left to the FDA, but payers, healthcare providers and patients need a definitive diagnosis to ensure appropriate prescribing.

“SDx is encouraged by this much needed, breakthrough treatment but payers will likely require an accurate diagnosis to finalize prescribing guidelines to ensure access for the most appropriate patients and address issues associated with prior authorizations and copays,” says Frank Amato, CEO and president, SDx. “Payers can look to the DISCERN^TM test to support these determinations and confirm an accurate diagnosis of AD for patients in early dementia."

DISCERN is a CLIA certified, minimally invasive 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. SDx developed DISCERN to provide healthcare professionals a test to identify and distinguish AD in people recently diagnosed with dementia, even in the presence of co-morbid pathologies. DISCERN has been autopsy validated to identify AD against the NIH gold standard of dementia in life and plaque and tau at death.

“With the anticipated approval of this new drug, education is necessary to provide payers and healthcare providers with the most accurate diagnosis and to ensure treatment is optimized for appropriate patients,” Amato continues. “By utilizing the DISCERN test, all stakeholders can avoid unnecessary, invasive and expensive diagnostic procedures conventionally used to diagnose AD in people with dementia.”

DISCERN, which has demonstrated 95% sensitivity and 95% specificity in the diagnosis and management of AD, improves access to care and patient satisfaction. The test is the first of its kind to earn Proprietary Laboratory Analyses (PLA) Codes 206U and 207U.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221005005505/en/