C2N Diagnostics Awarded Rigorous New York State Department of Health Permit, Expanding Ability to Provide Its Blood Tests to Help Diagnose Alzheimer’s Disease

ST. LOUIS--(BUSINESS WIRE)--C2N Diagnostics, LLC (“C2N”) announces it has received its laboratory permit from the highly respected New York State Department of Health’s Clinical Laboratory Evaluation Program (CLEP). This accomplishment allows C2N to offer its PrecivityAD2™ and PrecivityAD® blood tests to help diagnose Alzheimer’s disease in New York State.

C2N CEO and President Dr. Joel Braunstein says, “We’re very proud to have met the quality standards established by New York State’s CLEP, which are widely regarded as a national benchmark for clinical laboratory performance."

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The Empire State joins 49 other states, Washington, D.C., Puerto Rico and select countries across Asia, Latin America, Europe and the Middle East in allowing the Precivity blood tests. The tests aid health care professionals in detecting amyloid plaques in the brain, a pathological hallmark of Alzheimer's disease, and support informed medical management and treatment decisions.

C2N CEO and President Dr. Joel Braunstein says, “We’re very proud to have met the quality standards established by New York State’s CLEP, which are widely regarded as a national benchmark for clinical laboratory performance. Achieving this certification reflects rigorous scientific work by our team and a company-wide commitment to ensuring that every test we deliver meets the highest levels of accuracy and reliability. As a result, we’re now able to help support New York State’s rapidly growing older population.”

The New York Alzheimer’s medical community is excited about the news, as it means it has a convenient and affordable way to evaluate patients, a necessary step before new disease-modifying treatments for Alzheimer’s can be prescribed.

With two disease-modifying therapies available for the earliest stages of AD, patients and their families understand the benefits of an early and accurate diagnosis.

There are many benefits to an Alzheimer’s disease early diagnosis, including:

• Get appropriate medical attention (including possible access to disease-modifying therapies)
• Start lifestyle adjustments
• Become eligible for clinical research
• Lower risks and plan better
• Enable earlier access to support
• Actively plan for your future

Dana, a patient, says, “When I heard about the blood test, I was encouraged to come in and have that done, to find out if I was in the category of early Alzheimer’s.”

The Precivity tests are only available through health care professionals. The PrecivityAD2™ blood test is intended for use in patients aged 50 and older with signs or symptoms of mild cognitive impairment or dementia who are undergoing evaluation of Alzheimer’s disease or dementia.

Further information is available at www.PrecivityAD.com and 1-877-C2N-DIAG (1.877.226.3424).

New York Clearance Builds on Other Milestones

The New York State news follows on the heels of other C2N accomplishments. In October, it submitted the first multi-analyte algorithmic blood test using high-resolution mass spectrometry (HRMS) for Food & Drug Administration (FDA) review via the 510k pathway.

The Journal of the American Medical Association last year published a landmark 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 result in patients who saw memory care specialists. The PrecivityAD2 test algorithm 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. In October, 2020, the company was the first to offer a widely accessible Alzheimer’s disease blood test, the PrecivityAD® test, to aid in the evaluation process.

C2N performs the tests in its CAP accredited, CLIA and ISO 13485:2016 certified facility in St. Louis, MO.

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, 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, Alzheimer’s Association and The Michael J. Fox Foundation. For more information visit www.c2n.com.