ST. LOUIS -- C2N Diagnostics, LLC (“C2N”), a specialty diagnostics company with a vision to bring Clarity Through Innovation®, has reached an agreement with BeauBrain Healthcare that brings its breakthrough diagnostic testing for Alzheimer’s disease to South Korea.

The partnership means health care professionals in South Korea now have access to C2N’s PrecivityAD2™ test, which is an innovative blood test intended for use in patients 50 and older with signs or symptoms of mild cognitive impairment or dementia. This test aids physicians in South Korea in detecting amyloid plaques in the brain, a pathological hallmark of Alzheimer’s disease, and informs medical management and treatment decisions.

Notably, 72% of South Korean physicians surveyed as part of a recent webinar indicated that they would be willing to adopt blood-based Alzheimer’s diagnostics once available. Interest was shown not only by neurologists and psychiatrists, but also by internal medicine and family medicine physicians.

In addition, data from the Korea-Registries to Overcome Dementia and Accelerate Dementia Research (K-ROAD) recently reported that C2N’s %p-tau217 biomarker, a component of the PrecivityAD2 blood test, is less affected than p-tau217 immunoassays by biological confounding factors such as body weight, renal function, and anemia, enabling more stable and reproducible diagnosis of amyloid pathology in patients presenting with medical comorbidities. These findings have been published in leading international journals, including JAMA and JAMA Neurology, earning broad academic and clinical recognition for blood-based Alzheimer’s disease diagnostics.

C2N President and CEO Dr. Joel Braunstein says, “We endorse BeauBrain’s vision for ‘a world where all people can be free from the obscure fear of dementia’ and are proud they have selected C2N’s PrecivityAD2 blood test for this partnership. We recognize they have many options to choose from and their decision further affirms our role as a global leader in diagnostic testing for Alzheimer’s disease.”

“Early diagnosis is the entry point of successful and effective prevention when it comes to Alzheimer’s disease,” says co-CEO Jae Hak Kim. “Without an early diagnosis, prevention for further progression cannot happen. I co-founded BeauBrain Healthcare to help deliver innovative solutions in a wide array of clinical settings and am honored to partner with C2N Diagnostics, given the rigorous scientific validation supporting the PrecivityAD2 blood test.”

Developments Drive Need for Alzheimer’s Disease Diagnosis

The need for an early and accurate diagnosis of amyloid plaques in the brain is especially urgent as both the U.S. Food & Drug Administration (FDA) and the South Korean Ministry of Food and Drug Safety have recently approved disease-modifying therapies that target the underlying causes of dementia.

Previously, an Alzheimer’s diagnosis required amyloid PET imaging, which had limited accessibility, had a high cost, and involved radiation exposure.

Research Affirms Repeatable, Reliable, and Robust Performance of PrecivityAD2

The Journal of the American Medical Association (JAMA) published a large clinical study that found that the PrecivityAD2 blood test result improved diagnostic accuracy of Alzheimer’s disease, compared to standard of care practice without biomarker testing. This improvement occurred in both secondary care and primary care settings. Primary care is where most patients with cognitive concerns turn to for initial answers about their memory loss.

npj Dementia, which is part of the Nature Portfolio, also published research that the PrecivityAD2 blood test demonstrated 91% accuracy, 90% sensitivity and 92% specificity using the test’s CLIA-established cutoff versus amyloid PET imaging. C2N says the outcome confirms the test’s “repeatable, reliable and robust” performance.

In addition, the FDA awarded C2N’s proprietary brain amyloidosis blood test its Breakthrough Device designation and it achieved medical device registration from the United Kingdom’s Medicines & Healthcare products Regulatory Agency.

C2N’s Ties to Samsung and to Samsung Medical Center

Last year, C2N announced a $10 million USD investment from Samsung C&T Corporation, Samsung Biologics, Samsung Bioepis, and Samsung Venture Investment Corporation (collectively hereinafter referred to as “Samsung”). C2N said Samsung’s decision bolstered its ability to further scale its clinical laboratory services and advanced diagnostic solutions in the field of brain health.

Doctors’ offices may contact BeauBrain Healthcare about the PrecivityAD2 test at pbm@beaubrain.bio.