Cognoptix Co-Founder Lee Goldstein, M.D., Ph.D. Joins Cognoptix Board of Directors and Scientific Advisory Board
MARLBOROUGH, Mass., Dec. 21, 2020 /PRNewswire/ -- Cognoptix, a leading healthcare company for early-stage detection of Alzheimer's disease (AD), announces its co-founder, Lee Goldstein, M.D., Ph.D. has joined Cognoptix's Scientific Advisory Board, serving as Co-Chair, and the company's Board of Directors.
Cognoptix's Sapphire II System is a transformational, point-of-care medical device that identifies early-stage AD by detecting Alzheimer's β-amyloid (Ab) in the lens of the eye. Aβ accumulates in the brain as amyloid plaque, a hallmark pathology of the disease. Dr. Goldstein's foundational research identified Aβ in the lens and is considered to be the first evidence of AD-related amyloid pathology outside the brain. Building on Dr. Goldstein's research, Cognoptix developed the Sapphire II System to detect Aβ in patients long before onset of cognitive symptoms.
"I am pleased to join the Cognoptix team to help bring this powerful and pioneering diagnostic technology into wide clinical use. It's exactly what patients, clinicians, and the field needs—even more so now as new treatments for AD are nearing approval for clinical use," said Dr. Goldstein. "Effective treatment requires early detection. This is why Sapphire II is so important."
The Sapphire II system affords unique advantages compared to available AD tests. Providing a non-invasive window to the brain, Sapphire II is a safe, sensitive, cost-effective and radiation-free test designed for use in primary care, neurology, ophthalmology, and other outpatient clinical settings.
The ability to gain clarity about one's risk for AD and take appropriate actions early in the disease offers tremendous value. If approved by the FDA, the Sapphire II test will be an important new tool for physicians to aid in the evaluation of early dementia. It is positioned to be the first eye test to predict results comparable to brain amyloid PET scan in adults with early memory complaints or dementia at a fraction of the price of a PET scan. Furthermore, Sapphire II will be a tool to stratify enrollment in large pharmaceutical clinical trials, combatting the challenge of costly, high screening failure.
"We are excited to bring Dr. Goldstein back to Cognoptix as we move the Sapphire II system into its final stages of clinical development. Our clinical evidence indicates that the Sapphire II system quantitatively compares well in predicting results to amyloid PET imaging, the current platform used to detect amyloid in the brain. Sapphire II is especially favorable in detecting patients earlier. We anticipate that Dr. Goldstein's insights will further accelerate our progress towards FDA approval," said Dr. Wilke, Cognoptix President & CEO.
Dr. Goldstein's involvement will enhance the company's efforts to align the foundational science and clinical research that underpin development of the Sapphire II system. Dr. Goldstein will also facilitate academic collaborations with and broaden engagement in the AD research community in the US and abroad. He joins Dr. Susanne Wilke, President & CEO of Cognoptix appointed in early 2019, and her team as the company prepares for upcoming Sapphire II pivotal trials.
Dr. Goldstein and his team made the seminal discovery that Ab accumulates in the ocular lens of patients with Alzheimer's disease.1 Dr. Goldstein continues his research at Boston University School of Medicine where he co-leads the Biomarker Core of the NIH-funded Boston University Alzheimer's Disease Research Center. His team predicted and identified Ab lens pathology as the molecular etiology of lens opacification in people with Down syndrome, a chromosomal disease that also results in early-onset Aβ pathology in the brain.2 In another study, Dr. Goldstein and colleagues investigated 1,249 members of the Framingham Eye Study and found that AD-linked abnormalities are expressed many years to a decade or more earlier in lens than brain.3 The team also identified a new AD risk gene (CTNND2) that modulates Ab expression in both lens and brain. Dr. Goldstein's research established the strong scientific foundation on which the Cognoptix Sapphire II system is based.
For more information on Cognoptix and to learn more about Dr. Lee Goldstein, visit: https://cognoptix.com
1. Goldstein LE, Muffat JA, Cherny RA, et al. (2003) Cytosolic ß-amyloid deposition and supranuclear cataracts in lenses from people with Alzheimer's disease. Lancet 361,1258-65.
2. Moncaster JA, Pineda R, Moir RM, et al. (2010) Alzheimer's amyloid-β links lens and brain pathology in Down syndrome. PLoS ONE 5(5), e10659.
3. Jun G, Moncaster JA, Koutras C, et al. (2012) δ-Catenin is genetically and biologically associated with cortical cataract and future Alzheimer brain changes. PLoS One 7(9): e43728.
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