NEW YORK – Neurology firm C2N Diagnostics said Monday that its PrecivityAD2 Alzheimer's blood test has received medical device registration from the UK's Medicines and Healthcare products Regulatory Agency (UK MHRA).
The UK MHRA is the first regulatory agency globally to approve the PrecivityAD2 test for use as an in vitro diagnostic, C2N said. UK-based healthcare providers can now order the test to aid in the diagnosis of Alzheimer's disease.
PrecivityAD2 measures the Aβ42/Aβ40 ratio and p-tau217/N-p-tau217 ratio in plasma to assess the likelihood that individuals with mild cognitive impairment or dementia have the brain amyloid pathology characteristic of Alzheimer's disease. It is intended as a less expensive and less invasive alternative to existing tools for diagnosing Alzheimer's like cerebrospinal fluid testing and PET scans.
St. Louis-based C2N launched the test in the US in 2023 as a laboratory-developed test and signed a deal last year with Unilabs to sell the test in countries including the UK, Norway, Switzerland, Peru, Saudi Arabia, and the United Arab Emirates.
"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," C2N CEO Joel Braunstein said in a statement. "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."
“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 aging population," Lefkos Middleton, professor of neurology at the School of Public Health at Imperial College London, said in a statement. "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."
According to the Institute for Health Metrics and Evaluation, the UK has the second-highest rate of Alzheimer's per capita, with 42 cases per 100,000. It also has roughly one-tenth as many PET scanners as the US.