C₂N Achieves More Advancements in Brain Health Diagnostics
C₂N Diagnostics continues to build on its mission to provide exceptional laboratory services and products in the field of brain health. Its latest success is the news that the Accreditation Committee of the College of American Pathologists (CAP) has awarded accreditation to C₂N Diagnostics’ lab based on results of an on-site inspection.
The accreditation for C₂N’s state-of-the-art lab in the Cortex Innovation Community in St. Louis is in addition to its Clinical Laboratory Improvement Amendments (CLIA) certification. CLIA regulates laboratory testing and requires clinical laboratories to be certified by the Centers for Medicare and Medicaid Services before they can accept human samples for diagnostic testing.
In addition, research reports presented at premier Alzheimer’s disease and aging conferences in late 2021 added to the increasing set of details about the accuracy of the PrecivityAD™ blood test from C₂N Diagnostics. Data presented from the AHEAD Study investigators at the international Clinical Trials on Alzheimer’s Disease (CTAD) conference showed the PrecivityAD™ test is 81% accurate (with an area under the receiver operating characteristic curve (AUROC) of 0.87) in predicting the level of amyloid on a PET scan.
In addition, Suzanne Schindler, M.D., Ph.D., with Washington University School of Medicine, presented data from 1,085 individuals that showed the PrecivityAD™ blood test was highly concordant with CSF biomarkers and amyloid PET status in both cognitively normal (74% of those studied) and cognitively impaired (26%) individuals.
Another research project, presented at Gerontological Society of America Annual Meeting, found that patients received more precise diagnoses with the PrecivityAD™ blood test.
The AHEAD Study, a landmark prevention trial occurring at 75 research centers aimed at preventing memory loss in high-risk individuals, also announced that it will use the PrecivityAD™ blood test to provide an initial screen for study eligibility. This is the first time the PrecivityAD™ blood test will be used this way.
Dr. Joel Braunstein, president and CEO of C₂N, says, “2022 will indeed be an impactful year where our PrecivityAD™ blood test and additional innovations from C₂N will continue to advance our vision to provide the highest quality and best clinical value in brain health diagnostics.”
The PrecivityAD™ blood test identifies whether a patient is likely to have amyloid plaques in the brain. The test relies on precise and robust quantitation of the Amyloid Beta 42/40 ratio (Aβ 42/40) and determines the presence of apolipoprotein (ApoE)-specific peptides in blood samples, using C₂N’s proprietary mass spectrometry platform.
The PrecivityAD™ test is intended for use in individuals experiencing memory and thinking issues. The test is only available through an order by a health care provider.
Ask the Expert
John H. Contois, Ph.D., is C₂N’s Laboratory Director. Contois received his Ph.D. in nutritional sciences from the University of Connecticut, where he focused on the clinical utility of apolipoproteins as cardiovascular disease risk factors. He received his bachelor of science degree from the University of Massachusetts at Boston and master of science degree from the University of Connecticut. Contois received board certification in clinical chemistry and is a fellow of the American Association of Clinical Chemistry. He has served as laboratory director in both hospital and commercial settings. Contois currently serves on the editorial boards of Clinica Chimica Acta, Practical Laboratory Medicine and the Journal of Clinical Lipidology. He has published more than 50 articles and book chapters.
Question to John: What attracted you to working in this space? What’s it like to be a part of the C₂N lab team?
John’s Answer: In graduate school I worked on developing methods for measurement of vitamin A, vitamin E and carotenoids in blood. Later, in a specialty cholesterol lab, I set up one of nine Centers for Disease Control and Prevention Cholesterol Reference Method Laboratories and discovered that I enjoyed clinical aspects of laboratory science. I was unaware at the time that there was a pathway for those who’ve earned a PhD to obtain credentials to be clinical laboratory directors, but once I learned about this option, I knew this was the career I would pursue.
I was attracted to C₂N Diagnostics because I recognized the importance of its mission and the quality of the science. The lab team is remarkable and a pleasure to work with every day. I was very impressed by their expertise, the quality of testing that they achieve, and their commitment to making a difference in the lives of people who are facing memory problems.
Q: What happens next and what’s in the future?
A: We just relocated to new state-of-the-art laboratory space on Duncan Avenue in St. Louis and are preparing to accommodate the increased testing volume we are seeing. In addition, we are preparing our application for New York state certification, which is more involved than for other states. Our research team is also working on innovative new tests that will enable us to continue providing the best solutions in brain health diagnostics.
In the News
A St. Louis man recently shared with the NBC station in St. Louis why he decided to take the PrecivityAD™ blood test after his doctor recommended it. He is dealing with memory loss and other cognitive issues; he and his wife feared he had Alzheimer’s disease. Ultimately, his doctor diagnosed him with a cognitive issue other than Alzheimer's disease. Now he and his wife they have the answers they need to better plan for his care. Watch the story from KSDK-TV about their experience: https://lnkd.in/dVS32HhT
Association of American Medical Colleges (AAMC) included the PrecivityAD™ blood test in its story “8 medical advances you may have missed during COVID-19” and explained how PrecivityAD™ detects amyloid plaques that are a hallmark of Alzheimer’s disease.
www.aamc.org/news-insights/8-medical-advances-you-may-have-missed-during-covid-19
Howard Fillit, MD, founding executive director, Alzheimer's Drug Discovery Foundation, provided his perspective on the state of Alzheimer’s disease. He wrote about how the PrecivityAD™ blood test is the first to be used as a screening tool in a clinical trial and what it means for the future of diagnosis and the development of new therapies.
www.neurologylive.com/view/promise-alzheimer-disease-pipeline-holds-2022
HEC-TV reported on the benefits of the PrecivityAD™ blood test for aiding in the diagnosis of Alzheimer's disease and why an early diagnosis is helpful.
www.youtube.com/watch?v=0buXRG7GhtM&t=3s
C₂N CEO Dr. Joel Braunstein also explained that the company is “really the first group to introduce a blood test to the market to aid in the clinical diagnosis of Alzheimer's disease.”
www.youtube.com/watch?v=7ielmJ8ShwM&t=5s
About C₂N Diagnostics, LLC
C₂N Diagnostics is a specialty diagnostics company with a vision to bring Clarity Through Innovation™. C₂N strives to provide exceptional laboratory services and products in the field of brain health. C₂N’s biomarker services and products are used for: clinical decision making to improve patient care, including diagnosis and treatment monitoring; maximizing the quality and efficiency of clinical trials that test novel treatments for neurodegeneration; and providing innovative tools to help healthcare researchers better understand novel mechanisms of disease, identify new treatment targets, and conduct important epidemiologic studies to improve global public health. For more information visit www.C2N.com.
For the latest news and updates, please visit https://precivityad.com.