C2N Diagnostics Gains U.K. Certification for Alzheimer’s Blood Test

C2N Diagnostics LLC has achieved a significant milestone by obtaining U.K. medical device certification for its PrecivityAD2 blood test. This marks the first global regulatory approval for an in-vitro diagnostic designed to detect Alzheimer’s disease, enabling faster and more accessible diagnosis for those experiencing cognitive decline.

The approval from the U.K.’s Medicines and Healthcare products Regulatory Agency allows C2N’s PrecivityAD2 blood test to be used in patients aged 55 and older who show signs of mild cognitive impairment or dementia. With Alzheimer’s disease cases in the U.K. at 42 per 100,000 people, the country faces a pressing need for efficient diagnostic solutions. The PrecivityAD2 blood test, boasting a Negative Predictive Value (NPV) of 95% and a Positive Predictive Value (PPV) of 95% in recent studies, rivals traditional PET scans and cerebrospinal fluid tests for accuracy. The U.K.’s limited PET scanner availability further underscores the test’s significance, offering an efficient alternative in diagnostics and patient care pathways.

This regulatory milestone could transform Alzheimer’s disease management in the U.K., delivering timely diagnoses and informed treatment decisions. As the prevalence of Alzheimer’s rises, the PrecivityAD2 blood test positions itself as a crucial tool in managing care and reducing disease-related costs. Such advancements not only promise enhanced patient outcomes but also underscore the importance of innovation in the face of growing healthcare challenges.

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