C2N Diagnostics bags UK MHRA approval for PrecivityAD2 blood test, advancing Alzheimer’s diagnosis

C2N Diagnostics, LLC, a leader in advanced diagnostic solutions for neurodegenerative diseases, has obtained medical device certification from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (UK MHRA) for its PrecivityAD2 blood test. This regulatory milestone makes PrecivityAD2 the first globally approved in-vitro diagnostic (IVD) blood test designed to aid in the detection of Alzheimer’s disease.

C2N CEO Dr. Joel Braunstein described the approval as a significant step in tackling the rising prevalence of Alzheimer’s disease in the UK. He noted that as cases and healthcare costs continue to escalate, the introduction of a high-performing blood biomarker test could play a crucial role in reducing diagnostic delays and supporting earlier clinical decision-making. The approval also signifies an opportunity to enhance accessibility to Alzheimer’s diagnostics, particularly in regions with limited access to traditional imaging tools like positron emission tomography (PET) scans.

What makes the PrecivityAD2 blood test a breakthrough in Alzheimer’s diagnostics?

The PrecivityAD2 blood test is an analytically and clinically validated diagnostic tool designed to assess the presence of brain amyloid plaques, a hallmark of Alzheimer’s disease. It is intended for patients aged 55 and older who exhibit symptoms of mild cognitive impairment or dementia and are undergoing evaluation for Alzheimer’s disease or other forms of cognitive decline.

Unlike conventional diagnostic methods such as cerebrospinal fluid (CSF) testing or PET imaging, which are invasive, expensive, and often inaccessible to many patients, PrecivityAD2 offers a non-invasive alternative. By leveraging a blood-based biomarker analysis, this test provides a streamlined approach to Alzheimer’s screening, allowing healthcare providers to assess the likelihood of amyloid plaque accumulation with a simple blood draw.

Why is the UK an important market for blood-based Alzheimer’s diagnostics?

The UK has one of the highest per capita rates of Alzheimer’s disease globally, with 42 cases per 100,000 people, according to the Institute for Health Metrics and Evaluation. Only Finland surpasses the UK in terms of Alzheimer’s prevalence. As the country’s ageing population continues to grow, experts anticipate a significant rise in dementia-related cases, increasing the demand for early and efficient diagnostic solutions.

Professor Lefkos Middleton, a neurology expert at Imperial College London, highlighted the UK’s urgent need for innovative diagnostic solutions. He explained that blood biomarker tests like PrecivityAD2 could serve as a critical tool in enhancing early diagnosis and optimising patient care pathways. He further emphasised that timely detection is essential, as studies have shown that lifestyle modifications can slow disease progression when implemented early.

Beyond early detection, biomarker tests play a key role in treatment planning. By identifying individuals with amyloid-positive profiles, these tests can help physicians determine eligibility for clinical trials and facilitate more targeted treatment strategies. Dr. Middleton pointed out that recent peer-reviewed studies demonstrated that PrecivityAD2 performs comparably to gold-standard PET and CSF tests, reinforcing its clinical value.

How accurate is the PrecivityAD2 blood test compared to traditional diagnostic methods?

A prospective study published in the Journal of the American Medical Association (Palmqvist et al., 2024) evaluated PrecivityAD2 in over 1,200 patients across primary and specialty care settings. The study reported that PrecivityAD2’s clinically validated algorithm achieved a 92% Negative Predictive Value (NPV) and 91% Positive Predictive Value (PPV) with a single cutoff, while a two-cutoff approach yielded 95% accuracy. These results exceed expert consensus recommendations for an Alzheimer’s blood biomarker test, positioning PrecivityAD2 as a viable alternative to PET and CSF testing.

Dr. Braunstein noted that the UK faces a major shortfall in PET scanning capacity, with only 0.5 PET scanners per million people. This figure is six times lower than Germany‘s and one-tenth of the United States’ capacity, underscoring the critical need for an accessible, cost-effective alternative like PrecivityAD2.

What impact will PrecivityAD2 have on the UK’s healthcare system?

The introduction of PrecivityAD2 in the UK could alleviate diagnostic bottlenecks by offering a scalable solution for Alzheimer’s screening. By reducing reliance on invasive procedures and expensive imaging technologies, the test has the potential to improve patient access to timely and accurate diagnosis, ultimately enhancing clinical management strategies.

Beyond individual patient benefits, the wider adoption of blood-based Alzheimer’s diagnostics could also contribute to long-term cost savings for the UK’s National Health Service (NHS). Studies suggest that delays in diagnosis and misdiagnosis of Alzheimer’s disease contribute significantly to unnecessary healthcare expenditures. By implementing blood biomarker testing as a frontline diagnostic tool, healthcare providers could streamline patient referrals, optimise resource allocation, and enhance early intervention efforts.

Who can access the PrecivityAD2 blood test in the UK?

At present, the PrecivityAD2 blood test is available exclusively to healthcare providers. Physicians can order the test as part of an Alzheimer’s diagnostic workup, ensuring that patients experiencing cognitive symptoms receive a thorough assessment.

With UK MHRA approval secured, C2N Diagnostics aims to collaborate with healthcare institutions, research centres, and clinicians to expand access to blood-based Alzheimer’s diagnostics across the country. The company envisions a future where blood biomarker testing becomes an integral part of routine Alzheimer’s screenings, helping to bridge gaps in diagnostic accessibility and enhance patient outcomes.

A step forward in Alzheimer’s disease management

The MHRA certification of the PrecivityAD2 blood test marks a significant advancement in Alzheimer’s diagnostics, providing a clinically validated, non-invasive alternative to traditional testing methods. With high diagnostic accuracy, scalability, and ease of implementation, the test has the potential to transform the way Alzheimer’s disease is detected and managed in the UK.

As dementia cases rise and healthcare resources face increasing strain, innovative blood-based solutions like PrecivityAD2 offer a promising path forward, enabling earlier intervention, improved treatment decision-making, and more efficient use of healthcare infrastructure.