FDA Clears C2N Diagnostics’ PrecivityAD2® — First Alzheimer’s Blood Test for Adults with Cognitive Symptoms as Young as 40

The U.S. Food & Drug Administration (FDA) has cleared C2N Diagnostics’ PrecivityAD2® test, providing patients and health care professionals with an accurate, accessible, and scalable blood test to help diagnose Alzheimer’s disease in conjunction with standard clinical workup. An estimated 19-20 million U.S. adults aged 65 and older, and hundreds of thousands more between ages 45 and 65 are living with cognitive impairment and may benefit from an early diagnosis¹.

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The PrecivityAD2® FDA-cleared test version is expected to be available later this year; the current CLIA-validated, PrecivityAD2® test offering remains available through C2N’s clinical laboratory.

The FDA-cleared PrecivityAD2® test is indicated for use in adults aged 40 years and older who present with signs or symptoms of cognitive impairment undergoing evaluation for Alzheimer’s disease or other forms of cognitive decline. The PrecivityAD2^® test is intended to be used in conjunction with clinical assessment to aid health care professionals (HCPs) experienced in the evaluation of cognitive impairment to identify patients with amyloid pathology associated with Alzheimer’s disease. The test is not intended as a screening or stand-alone diagnostic test.

PrecivityAD2® as an in vitro device is unique in multiple ways:

• It is the only test FDA cleared for use in symptomatic adults aged 40 and over;

• In a clinical validation study of 1,142 subjects presenting with signs or symptoms of cognitive decline, PrecivityAD2® using dual cutoffs to detect brain amyloid plaques demonstrated a 97.6% positive predictive value (rule-in) for a Positive result and a 93.1% negative predictive value (rule-out) for a Negative result, based on established reference methods of amyloid PET visual read or cerebrospinal fluid (CSF) biomarker testing. A Likely Positive test result occurred in 17.3% of the subjects and had a 77.3% positive predictive value. Every PrecivityAD2® test result category provides medically important information to help HCPs determine appropriate next steps in the clinical care journey;

• The test was effective at detecting amyloid plaques across the spectrum of cognitive impairment evaluated in the clinical study, including subjects with mild symptoms and those with more advanced cognitive concerns;

• PrecivityAD2® showed consistent, reliable diagnostic performance with increasing age and across 12 pre-specified chronic diseases commonly associated with aging, including: atrial fibrillation, autoimmune/inflammatory disease, chronic heart failure, chronic kidney disease, coronary heart disease, depression, diabetes, dyslipidemia, history of cancer, history of stroke or transient ischemia attack, high blood pressure, and obesity;

• PrecivityAD2® can be ordered by health care professionals experienced in evaluating patients with cognitive impairment.

PrecivityAD2® Blood Test Has Potential to Offer Patients Answers Without Needing PET Scan or CSF

C2N believes the FDA clearance is especially meaningful for HCPs and patients seeking timely information about brain amyloid pathology. PrecivityAD2® provides an accessible, blood-based option to aid in identifying amyloid pathology and help inform appropriate next steps in clinical care. Recent real-world evidence shows that using multiple high-performing biomarker tests as opposed to just one to confirm amyloid pathology and arrive at an Alzheimer’s diagnosis has potential to delay the time it takes to start amyloid targeting treatments².

Many people living with cognitive impairment remain undiagnosed, particularly during the earlier stages of disease. Timely and accurate diagnosis can help patients and their HCPs make informed care decisions and determine appropriate treatment options, including lifestyle modification and possibly amyloid-targeting therapies.

Combination of High-Resolution Mass Spectrometry with Multiple Analyte Algorithm Score Fuels PrecivityAD2® Test Rigor

Foundational strengths of C2N’s test lie in its use of high-resolution mass spectrometry (HRMS) for protein biomarker quantitation as well as simultaneous measurement of amyloid and tau proteins that are each integral to the biology of Alzheimer’s disease. HRMS is a powerful technology that represents the gold standard in clinical laboratory medicine for measuring protein biomarkers from blood with high analytical sensitivity and specificity.

For PrecivityAD2®, state-of-the-art HRMS simultaneously quantifies multiple specific plasma beta/β-amyloid and tau peptide isoforms in the blood, expressing these values as the Aβ42/40 ratio and p-tau217/np-tau217 ratio (%p-tau217). The two ratios are combined into a proprietary statistical algorithm to calculate an amyloid probability score 2 (APS2) ranging from 0-100 to identify the likelihood of amyloid pathology associated with Alzheimer’s disease.

FDA Clearance Adds to C2N’s Legacy of Achievements

C2N Co-Founder, CEO and President Dr. Joel Braunstein says, “The FDA clearance is a watershed moment for our company, the entire Alzheimer’s disease community, the field of molecular diagnostics, and precision medicine. We believe the PrecivityAD2® test will play a vital health system role in the years ahead to help streamline and simplify the complex diagnostic pathway that many patients face when dealing with serious memory concerns. The FDA decision is based on our evidence-based approach and commitment to scientific breakthroughs that translate into clinical care solutions intended to empower clinicians to deliver better care for their patients. We acknowledge and appreciate the Agency, all the study participants, our partners and many other stakeholders who joined us on this journey in believing that we need a clearer picture of brain amyloid plaque, a hallmark sign of Alzheimer’s disease.”

Learn more at www.c2n.com and 1.877.C2N.DIAG (1.877.226.3424). The Precivity® tests are only available through a licensed health care professional.

About C2N Diagnostics, LLC

C2N is a leading 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 200 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. Over 90,000 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.

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