Company Seeks to Establish a First in the Field of Medicine with Pioneering Diagnostic Algorithm Test Using High Resolution Mass Spectrometry
ST. LOUIS–(BUSINESS WIRE)–#Alzheimers—C2N Diagnostics, a world leader in advanced brain health diagnostics, has reached an exceptional new milestone with the submission of its innovative, accessible blood test to the U.S. Food and Drug Administration (FDA). This action further underscores the excellence of C2N’s groundbreaking test, which empowers health care professionals to detect brain amyloid pathology — one of the defining hallmarks of Alzheimer’s disease — with greater ease and confidence.
The company believes this is a first for the entire field of medicine: the first multi-analyte algorithmic blood test using high-resolution mass spectrometry (HRMS) submitted for FDA review, for use in the assessment of Alzheimer’s disease pathology. HRMS is a powerful technology that represents a significant advancement in the field of clinical laboratory diagnostics, enabling the detection of circulating proteins from blood with high analytical sensitivity and specificity.
C2N’s test uses state-of-the-art HRMS to simultaneously quantify the concentrations of multiple specific plasma 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 a score with a numerical value ranging from 0-100 to identify the presence or absence of brain amyloid pathology associated with Alzheimer’s disease.
C2N notes that this milestone is not only impactful for the Alzheimer’s disease clinical and research communities, but also for the global diagnostics industry and entire field of medicine.
Submission Builds on Accomplishments
C2N currently offers the Precivity™ line of blood tests for patients 50 and older with signs or symptoms of mild cognitive impairment or dementia. The tests help inform medical management and treatment decisions in addition to detecting amyloid plaques in the brain.
C2N performs the tests under the ISO 13485:2016 standard and in the company’s CAP accredited, CLIA certified laboratory in St. Louis.
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.
Earlier, 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 CEO and President Dr. Joel Braunstein says, “The FDA review is an important moment for our company, the entire Alzheimer’s disease community, the field of molecular diagnostics, and precision medicine. Our FDA filing reflects our evidence-based approach and commitment to scientific breakthroughs that translate to clinical care solutions intended to improve patients’ lives.”
The agency previously awarded C2N a Breakthrough Device designation in 2018, which the FDA says is “intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval.”
Dr. Howard Fillit, co-founder and chief science officer at the Alzheimer’s Drug Discovery Foundation, says, “We eagerly await the FDA’s review of the C2N blood test. For healthcare professionals, blood tests are invaluable tools to help rule Alzheimer’s disease in or out. We believe C2N’s tests to be accurate and actionable, reflecting the incredible progress we’ve made in the biomarkers space. Tools like these will be crucial to enabling precision medicine for Alzheimer’s. This submission is important news for the field and for the ADDF’s mission to rapidly accelerate the development of drugs to prevent, treat, and cure Alzheimer’s disease.”
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, Alzheimer’s Association, and The Michael J. Fox Foundation. For more information visit www.c2n.com.
Contacts
COMPANY CONTACT:
Joni Henderson
[email protected]
MEDIA CONTACT:
Adam Shapiro
[email protected]
202-427-3603
