Submission of C2N Diagnostics’ PrecivityAD2 Blood Test for FDA Review Underscores Continued Momentum Toward Precision Medicine

C2N Diagnostics announced today that it has submitted its PrecivityAD2 blood test to the U.S. Food and Drug Administration (FDA) for review, a key step toward broadening the availability of blood-based diagnostics, which will enable earlier diagnosis and intervention, moving the field toward a new era of precision medicine.

“This submission marks continued progress toward replacing more invasive and costly tests with accessible blood biomarkers – a transformation the ADDF has long envisioned and invested in,” said Dr. Howard Fillit, Co-Founder and Chief Science Officer of the Alzheimer’s Drug Discovery Foundation (ADDF). “Our nearly 20-year partnership with C2N Diagnostics helped bring the first blood test for Alzheimer’s to market and has continued to evolve along with the science, paving the way for precision care and demonstrating the effectiveness of venture philanthropy in advancing critical research.”

This milestone builds on the first FDA approval of an Alzheimer’s blood test earlier this year and reflects how the Alzheimer’s field is being shaped by the ADDF’s years of investment in diagnostic innovation.

“The ADDF was one of C2N’s earliest investors, and we greatly value the strength of our longstanding partnership,” said Dr. Joel Braunstein, Co-Founder and Chief Executive Officer of C2N Diagnostics. “Their early seed funding in 2008 helped catalyze the development of what would become the first Alzheimer’s blood test – a bold investment in promising science that has helped reshape the trajectory of the entire field.”

In 2024, the ADDF invested  $7 million in C2N Diagnostics through the Diagnostics Accelerator (DxA) to support development of a platform that will enable global access to their PrecivityAD2 test. The DxA is a $100M global research initiative launched in partnership with leading philanthropists – including the late Leonard A. Lauder, Bill Gates, and Jeff Bezos – to fast-track the development of biomarkers and diagnostic tools for Alzheimer’s.

While amyloid blood tests are a critical first step, the ADDF is focused on advancing next-generation biomarkers that reflect the broader biology of aging and align with today’s robust drug pipeline where over 70% of drugs target non-amyloid pathways.

“The next frontier in Alzheimer’s care is precision medicine,” added Dr. Fillit. “Like how cancer diagnosis uses multiple biomarkers to guide treatment, Alzheimer’s will rely on a wide range of tools, including digital technologies and blood panels, that can test for multiple pathways and work together to detect the disease early, monitor progression, and tailor combination therapies to each patient.”