Study Confirms DISCERNtm Alzheimer's Disease Diagnostic Projected to Save Nearly $5 Million Over Three Years for Medicare Advantage Plans, Avoids Inappropriate Prescribing of New, Expensive Medications

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 publication of "The Budget Impact of the DISCERNtm Diagnostic Test for Alzheimer's Disease in the United States" in Journal of Preventative Medicine . Results from the study show the DISCERN test, the only autopsy-validated skin test to detect AD, even in people recently diagnosed with dementia, can save nearly $5 million in just three years for a Medicare Advantage plan with one million beneficiaries.

"The economic burden of AD in the US is projected to increase significantly, reaching $1 trillion by 2050, signaling the clear need for early and accurate diagnosis to not only delay disease progression and improve patient outcomes, but also save money for government and payers," says Frederick Huie, M.D., medical director, CVS/Aetna, SDx advisory council member and one of the study's authors. "Ensuring patients receive accurate diagnoses is of growing urgency as upcoming AD drugs elicit safety concerns and rising costs for the US. It is estimated the US will spend $500 million on advanced imaging to support these drugs and between $7 billion to $37 billion annually if just a quarter of eligible adults take the medication, with drugmakers expected to earn more than $10 billion in combined sales by 2030. With an accurate diagnosis, payers can avoid inappropriate prescribing as well as the costs and risks associated with newly approved medications."

Highlights of the study include:

- The DISCERN test yielded a net savings of $63.11 per test per year for a savings of $4.75M over three years.
- A more accurate True Negative (TN) reduces costs associated with unnecessary care.
- A more accurate True Positive (TP) is linked to medication effectiveness and avoiding a delay in care.
- The cost of the DISCERN test is offset by higher overall costs associated with tests in the current diagnostic pathway, such as positron emission tomography (PET) or cerebrospinal fluid (CSF) testing.
- Further reducing the current use of medical imaging, such as magnetic imaging (MRI) and computed tomography (CT) scans, with DISCERN in a scenario analysis of the study, could generate a projected savings of $14.5M.
- This economic analysis included only symptomatic treatments. Considering the newly available anti-amyloid drugs, improving diagnostic accuracy in the community setting will likely increase the cost savings to the plans.

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. This becomes even more problematic when evaluating treatment options for patients in the early stages of dementia 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.

"Until now, there have been no easily accessible, autopsy-validated tests shown to accurately identify AD in people with dementia either alone or with mixed-dementia," says Frank Amato, CEO and president, SDx. "With the burden of these new anti-amyloid drugs on patients and the healthcare system, the value of the accuracy seen with DISCERN cannot be overstated. This skin test 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."

Amato further emphasizes that DISCERN is the first AD test of its kind to earn Proprietary Laboratory Analyses (PLA) Codes 206U and 207U from the Centers for Medicare and Medicaid Services (CMS). These assets, combined with this positive economic modeling data, position DISCERN as a key solution to reduce the economic burden of AD across the healthcare system.

"With demand for early-stage diagnosis at an all-time high, the introduction of this non-invasive test reinforces focus on supporting the most cost-effective approaches to identifying and managing AD in the community setting," says Amato.

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 DISCERNtm, 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: [email protected].