C2N Announces Major Global Expansion, Adds Six New International Partners

PrecivityAD2™ blood test now available in over seven additional countries with primary focus on regions with inadequate PET infrastructure

ST. LOUIS--(BUSINESS WIRE)--C2N Diagnostics, LLC (“C2N”), a specialty diagnostics company with a vision to bring Clarity Through Innovation®, is reaching additional global healthcare providers eager to use its PrecivityAD2™ blood test to help diagnose Alzheimer’s disease. The PrecivityAD2™ blood test allows healthcare providers to determine the presence or absence of amyloid pathology, a known hallmark of Alzheimer’s disease, for patients being evaluated for cognitive complaints through a simple, non-invasive blood test.

The company has secured partnerships with six new clinical reference laboratories and distributors, expanding its footprint to over seven additional countries.

C2N’s new partnerships are with:

• Accuserv Diagnostic Center (Philippines)
• Archerfish Precision Diagnostics (Singapore and other Southeast Asian markets; further details are available through its news release)
• Codex Genetics (Hong Kong)
• Dr. Dangs Lab (India)
• Medical Link (Israel)
• Milenia Labs (Costa Rica and Mexico)

C2N also maintains partnerships with leading labs around the world, including Grupo Fleury, Healius, Mayo Clinic Laboratories, and Unilabs, along with a research collaboration with Mediford.

Dr. Joel Braunstein, CEO of C2N Diagnostics, says, “These new international partnerships are intended to broaden access to C2N’s innovative Precivity™ portfolio of blood tests in markets facing growing healthcare pressures given aging populations, a lack of dementia specialists, and inadequate PET infrastructure. These partnerships are a testament to the science and research that have already assisted healthcare providers in delivering a clear picture of Alzheimer’s disease pathology to patients and their families in many countries. The growing burden of Alzheimer’s disease requires the healthcare system to explore new ways to offer less costly and more accessible diagnostic testing, and we look forward to helping more patients around the world receive an early and accurate diagnosis.”

The PrecivityAD2™ blood test involves a simple blood draw from the patient and is intended for patients aged 55 and older with signs or symptoms of cognitive impairment who are undergoing evaluation for Alzheimer's disease or other causes of cognitive decline.

PrecivityAD2™ Blood Test is Rigorously Analytically and Clinically Validated; Has High Accuracy

The Journal of the American Medical Association (JAMA) published a large clinical care study examining the ability of the PrecivityAD2 blood test algorithm to improve the diagnostic accuracy of Alzheimer’s disease in primary care settings, where most patients with cognitive concerns turn to for initial answers about their memory loss. The study found the PrecivityAD2™ test result delivered a highly statistically significant accuracy of over 90% at a pre-defined, single binary cutoff compared to cerebrospinal fluid (CSF) analysis or amyloid PET analysis.

All C2N’s Precivity™ tests are currently performed under the ISO 13485:2016 standard and in the company’s CAP accredited, CLIA certified laboratory.

About C2N Diagnostics, LLC

C2N is a specialty diagnostics company with a vision to bring Clarity Through Innovation®. C2N strives to provide exceptional clinical laboratory services and advanced diagnostic solutions in the field of brain health.

C2N’s high-resolution mass spectrometry-based biomarker services and products are used for: clinical decision-making to improve patient care, including diagnosis and treatment monitoring; maximizing the quality and efficiency of clinical trials that test novel treatments for neurodegeneration; and providing innovative tools to help healthcare researchers better understand novel mechanisms of disease, identify new treatment targets, and conduct important epidemiologic studies to improve global public health.

C2N assays have been used in over 150 Alzheimer’s disease and other research studies throughout the U.S. and the world. This includes landmark treatment and prevention trials involving disease-modifying therapies (DMTs) that are changing the trajectory of Alzheimer’s disease. C2N has ongoing collaborations with multi-national pharmaceutical and biotech companies, leading academic institutions, National Institute on Aging, Alzheimer’s Association, and other non-profits and consortiums in addition to research and distribution partnerships with leading labs around the world including Grupo Fleury, Healius, Mediford, Mayo Clinic Laboratories, and Unilabs. Over 50,000 Precivity™-related biomarker measures have been reported through peer-reviewed publications, with many more manuscripts currently under review.

The company acknowledges generous support from National Institute on Aging, GHR Foundation, Alzheimer’s Drug Discovery Foundation, BrightFocus Foundation, and Alzheimer’s Association. For more information visit www.c2n.com.