FDA Clearance of C2N Diagnostics’ PrecivityAD2 Blood Test Advances Precision Medicine for Alzheimer’s, Building on Groundwork Laid by Early ADDF Investment

The U.S. Food and Drug Administration announced today that it has cleared C2N Diagnostics’ PrecivityAD2 blood test for use in adults as young as 40 who are experiencing signs of cognitive impairment, making it the first FDA-cleared Alzheimer's blood test available to patients this young. The clearance builds on nearly 20 years of ADDF investment in C2N's science and reflects the growing momentum of blood-based diagnostics in bringing earlier, more accurate detection into mainstream care and moving the field toward a new era of precision medicine.

“Today’s clearance reflects how rapidly the field is advancing. Just over a year ago, there were no FDA-cleared blood tests for Alzheimer’s and now we have three,” said Isobel Coleman, Chief Executive Officer of the ADDF. "This is a proof point that sustained, early investment in translational science plays a catalytic role in moving promising ideas from the lab to patients. The ADDF first invested in C2N nearly two decades ago and has stayed committed as the technology matured into a diagnostic that is now transforming how Alzheimer's is detected and diagnosed. As PrecivityAD2 and tools like it move further into clinical practice, they will enable earlier detection, sharpen clinical trials, and build the foundation for precision medicine and combination therapies." 

The field has long recognized that Alzheimer's pathology can begin 15 to 20 years before symptoms appear. Closing that gap has been a key focus of the ADDF's work, and validated tools that reach patients earlier, including those in their 40s and 50s, help pave the way for earlier detection and, ultimately, earlier treatment.

The ADDF’s partnership with C2N Diagnostics began in 2008 with early seed funding that catalyzed the development of PrecivityAD, the first blood test to help diagnose Alzheimer’s. This support has continued, including a $7 million investment through the ADDF’s Diagnostics Accelerator (DxA), helping to establish blood-based biomarkers as a cornerstone of modern Alzheimer's research and care. Today's decision follows the FDA's clearance of Fujirebio's Lumipulse blood test, another ADDF-funded diagnostic, underscoring how early investment is driving a new generation of Alzheimer's blood tests for clinical use.

The FDA’s clearance of PrecivityAD2 comes at a pivotal moment, with the Alzheimer's field advancing at an unprecedented pace. PrecivityAD2 is part of the ADDF's robust diagnostics portfolio, which includes 47 active programs spanning seven different pathways. The ADDF is focused on advancing the next generation of biomarkers, including blood tests for tau and other mixed pathologies, multi-marker panels, AI-driven approaches, and diagnostics that reflect the broader pathobiology of the disease, which are key to enabling more precise treatment strategies tailored to individual patients.

"PrecivityAD2 reflects how far biomarker science has come, and it points to an even bigger opportunity ahead," said Laura Nisenbaum, PhD, Interim Chief Science Officer at the ADDF. "Tests like this don't just help to diagnose Alzheimer's, they can also identify the right patients for a clinical trial and confirm whether a drug is engaging its target. That kind of precision is already reshaping trial design: 83% of active Alzheimer's trials now incorporate a biomarker. As we validate the next generation of tools, we will move closer to the same transformative approach already common in cancer care: being able to match the right drugs to the right patient at the right time."