On Feb. 24, 2024, C2N Diagnostics (C2N) 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.

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.