Biological Dynamics Expands Biomarkers Research Into Alzheimer's With Funding From Alzheimer's Drug Discovery Foundation (ADDF)

The novel Verita™ diagnostics platform will power a portfolio of novel blood-based biomarkers for drug development tools

San Diego, CA /PRNewswire/ - Biological Dynamics, Inc., an innovative diagnostic company committed to improving global health, announces a new biomarkers program designed for drug development applications in Alzheimer's Disease (AD). The company will use its proprietary Verita™ platform to develop a portfolio of assays for detection and quantification of blood-based biomarkers associated with AD and other neurodegenerative conditions. The program is funded by the Alzheimer's Drug Discovery Foundation's (ADDF) Diagnostics Accelerator, an initiative that aims to fast-track the development of novel biomarkers for the early detection of Alzheimer's disease and related dementias.

It is estimated that AD affects approximately 50 million people globally. In 2018, the official failure rate associated with developing AD-targeting therapeutics stood at 99%, with a 100% failure rate for disease-modifying therapies for AD. One of the critical unmet needs in drug development is the lack of tools to measure brain-derived biomarkers in blood.

Recently, analysis of neural extracellular vesicles (EVs) has emerged as an area of interest due to their ability to traverse the blood-brain barrier. The protein and nucleic cargo that is transported by EVs has been shown to be reflective of underlying physiological and pathological states for many diseases, including AD. The new program will focus on developing Verita-based assays for detection of AD-associated biomarkers in plasma EVs and evaluating the feasibility of using these assays in drug development.

"We are thrilled to be able to draw on ADDF's expertise for the latest developments in Alzheimer's clinical research as we establish this exciting program," said Raj Krishnan, PhD, Biological Dynamics' founder and CEO. "Verita has the potential to become the first platform to offer standardized and reproducible blood-based testing for EV-based AD biomarkers, contributing to the development of successful disease modifying therapies for this debilitating disease."

"The path to successful Alzheimer's treatments starts with optimizing drug development, and the first critical step is developing reliable and accessible biomarkers that can help us to truly understand this disease," said Howard Fillit, M.D., Founding Executive Director and Chief Science Officer at the Alzheimer's Drug Discovery Foundation. "The Biological Dynamics program represents a valuable opportunity to radically simplify testing the EV-based biomarkers associated with AD, potentially accelerating advancement of drug development pipelines."

Currently, most biomarker studies for Alzheimer's and other neurodegenerative conditions rely on cumbersome testing of cerebral spinal fluid (CSF) samples for proteins associated with AD. Blood -based detection of EV associated biomarkers could offer a significant advantage, tracking the evolution of disease in Alzheimer's and other neurodegenerative conditions. Unfortunately, the gold standard for analyzing blood-based EVs has limited utility in high-throughput applications due to the large sample volume needs and complex multi-step/multi-day workflow (Kanninen et al, 2016). Biological Dynamics' novel platform, Verita, uses the Alternating Current Electrokinetic (ACE) method to enable a fully automated alternative for on-chip isolation and characterization of EV-based biomarkers. The platform has been used previously to detect EV-associated biomarkers in blood for many conditions, including cancers, TB, and traumatic brain injury.

About Biological Dynamics
Biological Dynamics, Inc., is an innovative diagnostic company committed to improving health outcomes by empowering healthcare and life science communities with novel diagnostics solutions. Biological Dynamics' proprietary lab-on-a-chip platform, Verita™, isolates circulating nanoparticles and macromolecules directly from whole blood, serum, or plasma without the need for pre-processing samples. The company is applying the platform toward developing novel diagnostic solutions in three disease areas: oncology, neuroscience, and infectious disease. For more information, please visit www.biologicaldynamics.com and follow us at @BiodynSD on Twitter.

About ADDF
The ADDF is a non-profit organization solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF has awarded more than $150 million to fund over 626 Alzheimer's drug discovery programs and clinical trials in 19 countries. To learn more about ADDF, visit the website at www.alzdiscovery.org.

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