Importance of Disease Biomarkers for Diagnosing Alzheimer’s Disease
Biomarkers measure what is happening inside the living body, shown by the results of laboratory and imaging tests. They help clinicians and scientists diagnose diseases and health conditions, identify at-risk individuals, and monitor responses to treatment and changes over time.
Many types of biomarker tests are used for research on Alzheimer’s disease (AD) and related dementias. This is important because changes in the brain typically begin years before memory loss or other symptoms emerge. Finding these changes early enough in the disease journey can identify individuals who are at the greatest risk of AD so that they can benefit from treatment.
DISCERN™ is the first autopsy-validated, highly accurate, minimally invasive test for the diagnosis of AD versus other forms of non-AD dementias and those with AD and other degenerative pathologies. This test is composed of three discrete assays that accurately assess the loss of synaptic activity in the brain due to AD and has been validated through biopsy. What’s more, the AD test’s assays have demonstrated >95% sensitivity and specificity.
Understanding the Science Behind DISCERN™
In the DISCERN™ test, skin cells from a patient sample are grown in the lab and then assessed in three assays:
Morphometric Imaging — a method of evaluating the ability of neurons to form networks. Studies have shown that neural network formations in peripheral skin cells are well correlated to activity in the brain.
Protein Kinase C Epsilon (PKCƐ) — an enzyme that regulates synaptic and neural growth and death, as well as regulates the formation and degradation of amyloid beta toxic proteins and tangles. Tissue concentrations of PKCƐ have been shown to correlate with those concentrations in the brain.
AD Index — Extracellular-signal-regulated kinase 1 (ERK1) and ERK2 are two enzymes found in fibroblasts. When quantitatively imaged their ratio is highly correlated with AD and their values were also inversely correlated with duration of disease (time from onset of AD symptoms).
The Value of DISCERN
DISCERN™ gives patients and families the answers they need, enables providers to make a conclusive diagnosis, and allows payers to establish protocols and prior authorizations for prescribing and reimbursing treatment. It also helps pharmaceutical companies identify appropriate clinical trial participants and may provide additional metrics to evaluate treatment response.
Going forward, this test can inform appropriate patient access to disease modifying therapies, in addition to the clinical and economic benefits of improved early, accurate diagnosis.
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