C2N Diagnostics Expands the PrecivityAD2™ Alzheimer’s Disease Blood Test Intended Use to Patients 50 Years and Older

Lower Age Limit Addresses Increasing Calls from Clinicians Seeking Access to the PrecivityAD2™ Test for Patients With Earlier Onset of Cognitive Symptoms;

Test Provides Potential to Inform Earlier Intervention

ST. LOUIS--(BUSINESS WIRE)--Clinicians worried about early-onset Alzheimer’s disease in patients with cognitive concerns between the ages of 50 and 55 years can now prescribe the PrecivityAD2™ blood test to aid in the diagnosis of the neurological disorder for that expanded population. The test helps healthcare professionals in the detection of amyloid plaques in the brain, a pathological hallmark of Alzheimer's disease, and helps inform medical management and treatment decisions.

C2N Diagnostics introduced the PrecivityAD2 blood tests two years ago for patients 60 years and older. C2N has now completed additional validation to lower the age limit to 50 and older (meaning those born in 1975 and before).

Alzheimer’s Disease International reports that 75% all dementia cases go undiagnosed across the globe, with the figure rising to 90% in developing countries. C2N believes the expansion of the age range for the PrecivityAD2 test can play a role in reducing these high numbers.

The Journal of the American Medical Association (JAMA) published a large clinical study examining the ability of the PrecivityAD2™ blood test 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 similar robustness for the PrecivityAD2 test in patients who saw memory care specialists. The PrecivityAD2 test 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.

The article, “Blood Biomarkers to Detect Alzheimer’s Disease in Primary Care and Secondary Care,” also states that these results involving over 1,200 patients were substantiated despite a relatively high rate of medical comorbidities such as cardiovascular disease, high cholesterol, chronic kidney disease, and diabetes among prospectively enrolled patients in both primary and secondary care. The paper further demonstrated the test’s effectiveness for those between the ages of 50 and 55. Further insights about Precivity’s clinical validity and performance are available on its website.

C2N CEO Dr. Joel Braunstein says, “We’ve been working diligently to meet the need for easy, accessible, and affordable blood tests for those patients and families who want answers in their early 50s, and we’re proud we’ve reached this milestone. We recognize that patients with mild cognitive impairment due to Alzheimer’s disease are very eager to access the new disease-modifying therapies, and scientists have stated these therapies are most successful when they start early. C2N believes it’s uniquely positioned, more than ever, to support the medical community in confirming Alzheimer’s disease pathology with its PrecivityAD2 test.”

Dr. Braunstein also says that C2N technology was used in the clinical trials of some of the latest therapies now available to patients with early Alzheimer’s disease.

In addition, the revised PrecivityAD2 intended use to allow for testing in patients 50 and older has been incorporated into the MHRA Medical Device Certification in the United Kingdom, which C2N announced earlier this year.

Precivity Test Availability and Quality Standards

The Precivity tests are available in 49 states in the U.S., excluding New York (where certification is pending), as well as the District of Columbia and Puerto Rico. C2N also recently signed additional global partners to broaden access in Asia, Latin America, Europe and the Middle East.

C2N’s Precivity tests for patient care are 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, Unilabs, and Mayo Clinic Laboratories. 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.