C2N Diagnostics Awarded U.K. Medical Device Certification for Alzheimer’s Blood Test

The United Kingdom’s Medicines and Healthcare products Regulatory Agency has granted medical device registration to C2N Diagnostics LLC (C2N) for the PrecivityAD2 blood test.

The PrecivityAD2 blood test is an analytically and clinically validated multianalyte blood test that can detect the presence of brain amyloid plaques, one of the neuropathological findings of Alzheimer’s Disease. PrecivityAD2 is intended for patients aged 55 and older with signs or symptoms of mild cognitive impairment or dementia who are being evaluated for Alzheimer’s disease or other causes of cognitive decline.

The United Kingdom has 42 Alzheimer’s disease cases per 100,000 people, second only to Finland with the highest number of cases per capita, according to the Institute for Health Metrics and Evaluation.

“The U.K. will benefit from blood biomarker tests to aid in the diagnosis and care pathways of Alzheimer’s disease, given existing diagnostic ecosystem challenges in an increasingly aging population,” said Dr. Lefkos Middleton, a neurology professor within the School of Public Health at Imperial College London. “Early and accurate diagnosis is a critical first step not only because lifestyle changes have proven to delay onset and disease progression but also because these blood-based tools will allow for more informed treatment decisions and clarify patient eligibility for ongoing clinical trials. Last year saw peer-reviewed publications on the PrecivityAD2 blood test that showed comparable performance to the ‘gold standard’ positron emission tomography and cerebrospinal fluid diagnostic tests that paved the way for this important regulatory milestone.”

A recent prospective study published in the Journal of the American Medical Association (Palmqvist et al, 2024) enrolled more than 1,200 patients in both the primary care and specialty care setting and showed 92% Negative Predictive Value (NPV) and 91% Positive Predictive Value (PPV) for the PrecivityAD2 clinically validated algorithm using a pre-defined, single cutoff, while a two-cutoff approach yielded 95% NPV & PPV. This performance exceeds recent expert consensus recommendations for an Alzheimer’s disease blood biomarker test to serve as a substitute for CSF or PET alternatives.

“The availability of the PrecivityAD2 blood test in the U.K. will play a key role in helping the country deal with the high burden of Alzheimer’s disease,” C2N CEO Dr. Joel Braunstein stated. “As the number of cases and costs are expected to keep rising with an aging population, C2N aims to provide all U.K. citizens with access to high-performing blood biomarker testing that can alleviate delays to diagnosis and clinical management decisions. Ultimately, this has potential to meaningfully lower long-term costs associated with this devastating disease.”

The United Kingdom has 0.5 PET scanners per million people, about six times less than Germany per capita and one-tenth of that of the United States, according to Alzheimer’s Research UK data. Dr. Braunstein said the statistic highlights the need for a high-performing blood test to help with Alzheimer’s diagnoses.

C2N is a specialty diagnostics company that 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 more than 150 Alzheimer’s disease and other research studies throughout the United States 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 labs worldwide including Grupo Fleury, Healius, Mediford, Mayo Clinic Labs and Unilabs. More than 50,000 Precivity-related biomarker measures have been reported through peer-reviewed publications, with many more manuscripts currently under review.

The company acknowledges support from the National Institute on Aging, GHR Foundation, Alzheimer’s Drug Discovery Foundation, BrightFocus Foundation and Alzheimer’s Association.