The body of evidence

DISERN™ is an autopsy-validated skin test that assesses several critical factors directly related to AD that regulate memory, the formation of synaptic connections among neurons, the levels of amyloid plaques, and levels of neurofibrillary tangles in the brain.

DISCERN™ Test Provides Definitive Diagnosis of Alzheimer's Disease and Degenerative Pathologies vs. Other Forms of Dementia Highly accurate, minimally invasive test is well positioned to help address a number of key issues that payers, providers and patients face when it comes to getting a definitive diagnosis for Alzheimer's Disease early in the patient journey.

DISCERN™ is estimated to decrease total costs by $4.75 M over three years, which equates to approximately $63.11 net savings per test per year for a cohort followed over three years. While the cost of diagnosis with DISCERN™ is higher than the cost of diagnosis with CDP modalities, the overall costs associated with the CDP are larger due to the longer time needed to receive a diagnosis as well as the higher number of patients who receive a misdiagnosis and require extra care.

Experts believe science has primarily focused on amyloid to accurately diagnose AD, when in reality, AD is a complex, neurodegenerative form of dementia that requires a more nuanced approach than the linear structure of current diagnostic pathways. While the underlying cause of AD is still unknown, experts agree that changes in the brain due to age, combined with genetic, environmental and lifestyle factors all play an important role in disease progression.

On the backdrop of a heated, very public debate regarding CMS coverage determinations and restricted patient access to new drugs to treat Alzheimer’s Disease (AD), there is little to no discussion about the real questions that will face most people suffering from cognitive decline: who is the right candidate for the drug and what other options are available to manage mild cognitive impairment (MCI) and AD dementia for those who are not candidates?

Shortcomings of Blood Biomarkers and Need for Definitive, Non-invasive Diagnostic Testing Part II

Shortcomings of Blood Biomarkers and Need for Definitive, Non-invasive Diagnostic Testing

DISCERN™ uses a minimally invasive skin biopsy to inform a definitive diagnosis of Alzheimer’s Disease (AD) in a patient living with dementia. In long-term clinical trials, DISCERN™ has accurately identified AD in people recently diagnosed with dementia (≤ 4 years from a dementia diagnosis), and patients with mixed dementias such as Lewy body dementia, vascular or frontal lobe dementia. The DISCERN™ test includes three assays evaluating critical factors directly related to AD, such as memory regulation, synaptic connections formation among neurons, and the levels of amyloid plaques and neurofibrillary tangles in the brain. DISCERN™ was granted the Food and Drug Administration (FDA) Breakthrough Device designation in 2018 and has Clinical Laboratory Improvement Act (CLIA) status in most states. In 2021, the DISCERN™ Laboratory Developed Test (LDT)/CLIA certified lab test was awarded Medicare reimbursement codes 206U and 207U, national reimbursement rates, and is paid for by Medicare.

The AD Index, as part of the DISCERN™ test, measure phosphorylation of ERK1 and ERK2 in response to an inflammatory agonist bradykinin to distinguish AD from normal controls and non-AD dementias. In blinded, autopsy-validated clinical trials, the AD Index has been shown to accurately identify AD, outperforming clinical diagnosis, in those recently diagnosed with dementia (94% specificity and 97% sensitivity). The AD Index can also accurately identify AD in people living with co-morbid dementias or additional causes of dementia, including multi-infarct dementia, Parkinson’s disease, or Frontal Lobe Dementia

The PKCε assay in the DISCERN™ test measures an enzyme found in the brain and peripheral tissues such as skin, associated with synaptic loss, amyloid-β elevation, and cognitive deficits in AD. The level of PKCε has been shown to accurately identify AD in those recently diagnosed with dementia (96% specificity and 100% sensitivity) and to distinguish AD from other causes of dementia, such as multi-infarct dementia, Parkinson’s disease, or Frontal Lobe Dementia.

In clinical trials, the morphometric imaging assay has demonstrated high sensitivity and specificity of results correlating with postmortem diagnosis as defined by the NIH Gold Standard. Diagnostically distinguishes AD from other forms of dementia, even in early-stage AD (≤4 years of a dementia diagnosis).