Aelan Cell Technologies today announced the development of a novel epigenetic biomarker. An early human clinical feasibility study has indicated that serological tests using the biomarker alongside other proprietary components developed by Aelan's researchers could potentially help physicians diagnose Alzheimer's disease (AD). Aelan has developed the test in two configurations: direct measuring of the biomarker in patient's serum alongside with a measurement of a patient's immunological response to its presence. This novel biomarker and its link to human aging was discovered in Dr. Victoria Lunyak's laboratory during her tenure at the Buck Institute. Dr. Lunyak is now the Founder, CEO, and President of Aelan.
"We are encouraged by the early results from these studies, and if our novel tests continue this stellar performance when taken from the research lab to a controlled clinical diagnostics environment, it may revolutionize the way we approach and treat Alzheimer's Disease," said Victoria Lunyak, Ph.D., the CEO and President of Aelan Cell Technologies. "Both tests demonstrate high predictive value and top of the scale sensitivity and specificity for Alzheimer's Disease." Sensitivity and specificity are intrinsic attributes of the evaluation of any test's performance. Tests with high sensitivity are used to rule out those without the disease, while tests with high specificity are used to rule in those with the disease.
Currently, diagnosing AD can be subjective, and conflicting outcomes from different physicians can occur. It is believed that pathological confirmation, usually gained through the prevalence of certain proteins, is not possible without a brain biopsy, so this disease often goes unrecognized until it has progressed significantly. For many years, there has been a clear need for less invasive AD testing, such as blood-based diagnostics. Additionally, there are currently no effective long-lasting drug treatments for AD, and it is believed that many new clinical trials fail because drugs are given too late in the progression of the disease. A blood test developed by Aelan that is able to diagnose Alzheimer's in its early stages could be used to identify patients for clinical trials of drugs designed to halt the progression of the disease.
"With the relatively untapped market of AD therapeutics and diagnostics, there is potential for significant growth," adds Chester Aldridge, CEO of US Equity Holdings and Chair of Aelan's Board of Directors. "Global IVD markers will reach $74.65 billion by 2020. For the next four years, the main drivers of the IVD industry sector will be an increased utilization of minimally invasive technologies and FDA confidence in the technologies that were de-risked over the past decades."
Currently, there are no biological markers available that enable preclinical detection or definitive premorbid diagnosis of AD. Worldwide, nearly 44 million people have Alzheimer's or a related dementia and only 1-in-4 people with Alzheimer's disease have been diagnosed (Alzheimer's Disease International). According to the American Association of Alzheimer's Disease, every 66 seconds someone in the United States develops AD and more than 5 million Americans are living with the disease. AD is one of the costliest chronic diseases to society. For instance, in 2015, AD and other forms of dementia cost the nation $236 billion. AD is the sixth leading cause of death in the United States and it's the only cause of death in the Top 10 in America that cannot be prevented, cured, or slowed with currently available therapies. Between 2000 and 2013, deaths attributed to Alzheimer's Disease increased 71 percent. By 2050, the projected cost to the nation could rise as high as $1.1 trillion. This dramatic spike includes a five-fold increase in government spending under Medicare and Medicaid and a nearly five-fold increase in out-of-pocket spending. Nearly one in every three seniors who dies annually has Alzheimer's or another form of dementia.
There is a clear need for research and development of Alzheimer's diagnostics and treatments. Aelan plans to open a larger study to validate the novel test's performance and is actively seeking a regulatory approval.
Source: Aelan Cell Technologies