C2N Diagnostics’ PrecivityAD2™ Blood Test Receives MHRA Medical Device Certification in the United Kingdom

First Global Regulatory Approval of PrecivityAD2 for Use as an In-Vitro Diagnostic to Aid in the Diagnosis of Alzheimer’s Disease

ST. LOUIS--(BUSINESS WIRE)--C2N Diagnostics, LLC (“C2N”), a pioneer in advanced diagnostic testing for brain health, today announced the medical device registration from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (UK MHRA) for the PrecivityAD2™ blood test.

The PrecivityAD2 blood test is an analytically and clinically validated multianalyte blood test that determines whether a patient is likely positive or negative for 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 undergoing evaluation for Alzheimer’s disease or other causes of cognitive decline.

The UK 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.

Dr. Lefkos Middleton, Professor of Neurology within the School of Public Health at Imperial College London says, “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 in an increasingly ageing population. 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 over 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.

C2N CEO Dr. Joel Braunstein says, “The availability of the PrecivityAD2 blood test in the UK will play a key role in helping the country deal with the high burden of Alzheimer’s disease. As the number of cases and costs are expected to keep rising with an aging population, C2N aims to provide all UK 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.”

Dr. Braunstein noted that Alzheimer’s Research UK has reported that the country only has 0.5 PET scanners per million people, about six times less than Germany per capita and a tenth of that of the United States, highlighting the need for a high performing blood test to aid in Alzheimer’s diagnoses.

Only healthcare providers can order the PrecivityAD2 test. Healthcare providers should email [e-mail] to learn more about how to order the test in the UK.

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 150 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, Mayo Clinic Labs and Unilabs. Over 50,000 Precivity™-related biomarker measures have been reported through peer-reviewed publications, with many more manuscripts currently under review.

The company acknowledges generous support from the National Institute on Aging, GHR Foundation, Alzheimer’s Drug Discovery Foundation, BrightFocus Foundation and Alzheimer’s Association. For more information visit www.C2N.com.