C2N Diagnostics’ PrecivityAD2™ Blood Test Gets MHRA Certification in the UK
C2N Diagnostics, LLC, a leader in advanced brain health diagnostic testing, today announced that its PrecivityAD2™ blood test has received medical device registration from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA).
C2N Diagnostics, LLC, a leader in advanced diagnostic testing for brain health, has recently announced that the PrecivityAD2™ blood test has been registered as a medical device by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). This significant milestone allows the PrecivityAD2 test to be made available in the UK, offering healthcare providers a reliable, clinically validated method to assess the presence of amyloid plaques in the brain, a hallmark of Alzheimer’s disease.
The PrecivityAD2 blood test is an analytically and clinically validated multianalyte blood test designed for patients aged 55 and older who are experiencing mild cognitive impairment or dementia symptoms. It helps determine whether a patient is likely to be positive or negative for brain amyloid plaques, a critical sign of Alzheimer’s disease. This test plays a crucial role in the diagnostic process for Alzheimer’s disease and other forms of cognitive decline.
In the UK, there are 42 cases of Alzheimer’s disease per 100,000 people, according to the Institute for Health Metrics and Evaluation. This rate is one of the highest globally, surpassed only by Finland, highlighting the pressing need for effective diagnostic tools to manage this growing health crisis.
Dr. Lefkos Middleton, Professor of Neurology at Imperial College London, commented on the importance of blood biomarker tests in improving Alzheimer’s disease diagnosis. He noted, “The UK will benefit from blood biomarker tests to aid in the diagnosis and care pathways of Alzheimer’s disease, given existing diagnostic ecosystem challenges and the country’s ageing population. Early and accurate diagnosis is crucial, as it can delay disease progression and improve patient care by enabling more informed treatment decisions.”
The PrecivityAD2 test has shown impressive results in recent studies, including a prospective study published in the Journal of the American Medical Association (Palmqvist et al., 2024), which enrolled over 1,200 patients. This study demonstrated a 92% Negative Predictive Value (NPV) and a 91% Positive Predictive Value (PPV) for the PrecivityAD2 clinically validated algorithm, using a predefined single cutoff.
In the two-cutoff approach, the NPV and PPV both increased to 95%, surpassing the performance of other Alzheimer’s disease blood biomarker tests currently on the market. The test’s exceptional accuracy sets a new standard for Alzheimer’s diagnostic tools, as it meets and exceeds expert consensus recommendations for using blood biomarkers as alternatives to cerebrospinal fluid (CSF) or positron emission tomography (PET) scans.
C2N’s CEO, Dr. Joel Braunstein, emphasized the significance of this advancement for the UK healthcare system. “The availability of the PrecivityAD2 blood test in the UK will play a crucial role in helping the country address the high burden of Alzheimer’s disease. With an ageing population, the number of cases and associated costs are expected to rise, and C2N aims to provide UK citizens with access to high-performing blood biomarker testing. This can reduce delays in diagnosis and clinical management, ultimately lowering the long-term costs associated with this debilitating disease.”
Dr. Braunstein also highlighted the limited access to diagnostic tools like PET scans in the UK, with only 0.5 PET scanners per million people. This is significantly lower than countries such as Germany and the United States, which have higher per capita access to these advanced diagnostic tools. The lack of PET scanners further underscores the importance of having a reliable blood test like PrecivityAD2 to aid in the timely diagnosis of Alzheimer’s disease.
As part of this expansion, healthcare providers in the UK can now order the PrecivityAD2 blood test to help assess their patients’ risk of Alzheimer’s disease.
C2N Diagnostics is a specialty diagnostics company with a mission to provide clarity through innovation. The company is dedicated to offering exceptional clinical laboratory services and advanced diagnostic solutions in brain health. C2N uses high-resolution mass spectrometry-based biomarker services and products to improve clinical decision-making, support clinical trials, and aid healthcare researchers in understanding novel mechanisms of disease. C2N’s assays have been used in over 150 Alzheimer’s disease and other research studies globally, including landmark trials involving disease-modifying therapies that are changing the trajectory of Alzheimer’s disease.
C2N has ongoing collaborations with multinational pharmaceutical companies, academic institutions, and organizations such as the National Institute on Aging and the Alzheimer’s Association. The company is also working with leading laboratories and research partners worldwide, including Mayo Clinic Labs, Grupo Fleury, Healius, and Unilabs. With more than 50,000 Precivity™-related biomarker measures reported in peer-reviewed publications, C2N continues to be a leader in advancing the understanding and treatment of Alzheimer’s disease.
In conclusion, the MHRA’s registration of the PrecivityAD2 blood test represents a critical step in improving Alzheimer’s disease diagnosis and care in the UK. With its high accuracy and ability to expand access to diagnostic testing, this blood test promises to help healthcare providers identify patients with Alzheimer’s disease more efficiently and at an earlier stage, ultimately improving patient outcomes and reducing healthcare costs.
