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

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.

“When clinicians reduce reliance on expensive and invasive tests such as PET scans and CSF punctures to identify AD, DISCERN can be cost saving,” says Amato. “In a published clinical utility study, most PCPs were dissatisfied with the current diagnostic approach, citing the burden and subjectivity of the diagnostic tools.”

Amato affirms that DISCERN has been shown in published economic models to be cost neutral when added to the current diagnostic pathway. Further raising confidence among payers, providers and patients, DISCERN is currently commercialized under a CLIA authorization, has received reimbursement codes, is currently paid for by Medicare Fee-For-Service and reimbursement is underway with commercial and Medicare Advantage payers.

Developed by SDx and designed to inform the presence of AD in people recently diagnosed with dementia, even when they have mixed-dementia, DISCERN 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.

Dr. Daniel Alkon, chief scientific advisor, SDx, explains, “In clinical trials, DISCERN demonstrated >95% sensitivity and specificity for identifying AD versus the NIH Gold Standard definition for AD – dementia in life and the presence of plaque/tau upon autopsy -- with the results of assays compared to the NIH standard. No other diagnostic tests have undergone this rigorous autopsy validation for early dementia and no autopsy-validated tests are available to make an accurate diagnosis throughout the progression from early to late AD.”

Dr. Alkon continues, “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. While amyloid plaques are pathologic hallmarks of the disease, at autopsy they have not been observed to closely correlate with patients’ cognitive decline.”

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/20230110005743/en/