Researchers in the United Kingdom are using the PrecivityAD2 blood test from C2N Diagnostics, LLC ("C2N") to prepare for the future acceleration of diagnosis and clinical decision-making in either primary care or for patients waiting to see dementia specialists.
The collaboration is occurring through C2N's partnership with the Davos Alzheimer's Collaborative (DAC). C2N's Alzheimer's blood biomarker was used in the initial DAC health system preparedness study in Brazil, Japan, Mexico, Scotland and the United States in 2021.
In a recent development, DAC's Healthcare System Preparedness program has started the Accurate Dx program. Imperial College London is the only United Kingdom center; there are four health systems located in the United States, two in the European Union and one in Japan. The UK study started recruiting patients in May.
Dr. Lefkos Middleton, Professor of Neurology at Imperial, said, "The recent emergence of blood-based biomarkers having comparable sensitivity and specificity to highly specialized imaging and cerebrospinal fluid tests has been a major breakthrough in the field of Alzheimer's disease. We are indebted to participating patients, their primary and specialist care physicians, as well as U.S.-based C2N Diagnostics as the technology partners in this study. These blood biomarkers hold the promise of transforming the diagnostic and care pathways across the globe, for the benefit of patients and their families."
The PrecivityAD2 test detects amyloid plaques in the brain with high diagnostic accuracy and is for patients 50 and older with signs or symptoms of mild cognitive impairment or dementia. At the Imperial site, in the study, Blood Biomarkers for Early and Accurate Diagnosis of Alzheimer's Disease in Primary Care (BEAD-PC), participating primary care physicians ("general practitioners") in North West London are using the PrecivityAD2 test, in addition to standard cognitive assessments prior to referral to dementia specialists at Imperial College Healthcare NHS Trust.
Crucially, the study is designed around testing the accuracy of PrecivityAD2 in primary care pathways for dementia diagnosis, placing this new technological approach directly within primary care research sites, rather than in hospital or specialist settings, for a quicker and more accurate diagnosis early in disease stages. Those whose results suggest early-stage cognitive impairment are referred to the Imperial Memory Unit at Charing Cross Hospital for further specialist evaluation.
Beyond its immediate clinical aims, the BEAD-PC study is designed to generate evidence that could inform how Alzheimer's diagnostics are delivered at scale across the National Health Service and other healthcare systems worldwide. By testing the integration of high performance blood-based biomarker testing into routine general practitioner appointments, the study seeks to address one of the most persistent challenges in dementia care: the gap between the onset of disease and the point at which it is formally diagnosed.
Professor David Wingfield, Professor of Practice at Imperial, said, "For too long general practitioners have operated in a 'grey area' where they respond to patient concerns without precise tools to define the nature of the disease process. For Alzheimer's disease we now have the tools in the form of blood biomarkers, which are easier for patients and help define the nature of the condition and point towards treatments that may help."
About C2N Diagnostics, LLC
C2N is a specialty diagnostics company with a vision to bring Clarity Through Innovation. C2N strives to provide exceptional clinical laboratory services and advanced diagnostic solutions in the field of brain health. C2N's high-resolution mass spectrometry-based 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. C2N assays have been used in over 200 Alzheimer's disease and other research studies throughout the U.S. and the world. This includes landmark treatment and prevention trials involving disease-modifying therapies (DMTs) that are changing the trajectory of Alzheimer's disease. C2N has ongoing collaborations with multi-national pharmaceutical and biotech companies, leading academic institutions, National Institute on Aging, Alzheimer's Association, and other non-profits and consortiums in addition to research and distribution partnerships with leading labs around the world including Grupo Fleury, Healius, Mediford, and Mayo Clinic Laboratories. Over 90,000 Precivity-related biomarker measures have been reported through peer-reviewed publications, with many more manuscripts currently under review.
The company acknowledges generous support from National Institute on Aging, GHR Foundation, Alzheimer's Drug Discovery Foundation, BrightFocus Foundation, Alzheimer's Association and The Michael J. Fox Foundation. For more information visit www.c2n.com.
Imperial College London
Imperial College London is a world-leading university for science, technology, engineering, medicine and business (STEMB), where scientific imagination leads to world-changing impact.
We were founded in 1907 with a mission 'To be useful', but we know that before anyone can usefully change something, they first need to understand it. That's what we do.
We use science to try to understand more of the universe, and improve the lives of more people in it. Across our London campuses, and throughout our international network, we ask bigger questions and so we shape the future. www.imperial.ac.uk
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