The U.S. Food and Drug Administration (FDA) has cleared C2N Diagnostics' PrecivityAD2 blood test for use in adults as young as 40 who are experiencing signs of cognitive impairment. The test is the first FDA-cleared Alzheimer's blood test available to people in this age group, marking a significant step forward in making Alzheimer's detection more accessible, earlier, and less invasive.
The milestone builds on nearly two decades of support from the Alzheimer's Drug Discovery Foundation (ADDF), which first invested in C2N Diagnostics in 2008 and has since contributed funding to advance blood-based diagnostic technologies. Experts say tools like PrecivityAD2 can help identify Alzheimer's disease earlier, improve patient selection for clinical trials, and support the development of more personalized treatment approaches.
The clearance reflects growing momentum in the use of blood-based biomarkers for Alzheimer's care. Researchers have long known that Alzheimer's-related changes in the brain can begin 15 to 20 years before symptoms appear, making early detection critical. As more advanced diagnostic tools become available, the field is moving toward a precision medicine approach, where treatments can be better tailored to individual patients based on their biology and disease progression.
Learn more about the FDA clearance of PrecivityAD2 and its potential impact on Alzheimer's diagnosis and care by visiting the Alzheimer's Drug Discovery Foundation website.
