SYNAPS Dx (SDx), a privately held company focused on the research, development and commercialization of a diagnostic test for Alzheimer’s disease (AD), is pleased to announce the release of its white paper, “Resolving a Diagnostic Dilemma.” This paper is a timely, authoritative document articulating a simplified diagnostic pathway to identify AD in the community primary care and neurology settings. Addressing some of the most pressing issues to elevate the current diagnostic approach, this potential diagnostic pathway leverages existing guidance to identify the right candidates for prescribing drugs to treat AD and for those without AD, it informs care plans to address modifiable risk factors of dementia.
“With the introduction of newly approved drugs to treat AD such as lecanemab, there is growing need to accurately identify the appropriate patients for prescribing these drugs, given their cost and risk/benefit profiles,” says Frederick Huie, M.D., medical director, CVS/Aetna and SYNAPS Dx advisory council member. “With studies showing that 40% of dementia cases may be preventable by addressing modifiable risk factors, a more accurate diagnosis of AD in the community setting can inform care plans to address comorbid conditions behind the dementia symptoms.”
Misdiagnosis is a significant challenge in the medical community with 50% to 70% of symptomatic AD patients not correctly diagnosed in primary care due to lack of routine cognitive screenings and accurate testing. The problem is exacerbated in the early stages of the disease in patients without dementia who experience cognitive decline or mild cognitive impairment (MCI). It is common for the symptoms of AD to be confused with a number of other medical conditions, some of which may be reversible, such as Lyme disease, vitamin deficiencies, thyroid issues, depression, drug interactions and other forms of dementia. These challenges combined with the safety considerations of available AD drugs makes an accurate AD diagnosis even more important.
“AD is complex, but an accurate diagnosis confirmed by DISCERN™ – the only autopsy-validated skin test – makes a more definitive diagnosis in the primary care setting more readily accessible and time- and cost-effective,” says Frank Amato, CEO and president, SDx. “In clinical studies, DISCERN has demonstrated >95% sensitivity and specificity for identifying AD versus other forms of dementia, even in people recently diagnosed with dementia.”
DISCERN significantly improves the accuracy of community-based AD diagnostics, enhancing the quality of specialist referrals and avoiding costly imaging, invasive cerebrospinal fluid puncture and expensive interventions. For providers, patients and payers, this diagnostic test may reduce costs, improve outcomes and increase patient satisfaction. Amato cites a study with 402 primary care physicians in which clinicians indicated they were five times more likely to diagnose and three times as likely to prescribe disease modifying drugs for AD with a positive DISCERN test.