C2N Makes Many Moves as It Advances Science
FDA, New HQ, and International Partners Highlighted
C2N Submits U.S. FDA Regulatory Filing for Its Alzheimer’s Disease Blood Test
C2N Diagnostics has reached an exciting new milestone in the field of precision medicine 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 test, which empowers health care professionals to evaluate for presence of 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: a 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 platform 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 likelihood for presence or absence of brain amyloid pathology associated with Alzheimer’s disease.
Dynamic Growth Leads C2N Diagnostics to Expand St. Louis Headquarters to Meet Global Need for Answers to Alzheimer’s Disease
C2N Diagnostics is proud to announce that its early achievements while based in St. Louis are allowing it to triple the size of its operations in its hometown.
C2N, a leader in advanced brain health diagnostics, will relocate its headquarters and expand its federally regulated CAP accredited-CLIA certified lab operation to 4140 Forest Park Ave. at Catalyst, Powered by WashU, in the Cortex Innovation District in Midtown.
Washington University is redeveloping the former Goodwill Industries International site. The new lab will leverage the latest advancements in bioautomation and high-resolution, high-throughput proteomic testing. Altogether, C2N will occupy 82,451 new square feet at Catalyst, filling the first three floors. C2N expects to begin the move in late 2026.
In addition to the new headquarters, C2N will maintain its existing ISO 13485:2016 compliant lab facility and turn it into a center dedicated to providing ongoing high quality biopharmaceutical research services while also introducing cutting edge multi-omic solutions and other advanced technology platforms to drive innovation across its clinical, data analytic, and international collaborative research initiatives.
Dr. Joel Braunstein, CEO of C2N, said, “This news is a testament to the enthusiastic backing we’ve received in St. Louis, the extremely talented team members we employ, and the health care professionals who’ve embraced our technology and premium quality testing services. We’re especially excited to be growing in the Cortex Innovation District, where we started and where we feel we exemplify its passion for providing the resources needed to shape the future.”
“The ongoing success of C2N Diagnostics in St. Louis is proof that Missouri is leading the way in groundbreaking medical research,” said Governor Mike Kehoe. “Their partnership with Washington University demonstrates the powerful impact of science and entrepreneurship happening right here in Missouri.”
C2N Announces Major Global Expansion, Adds Six New International Partners
C2N Diagnostics is reaching additional global health care professionals eager to use its PrecivityAD2™ blood test to help diagnose Alzheimer’s disease. The PrecivityAD2 blood test allows clinicians to evaluate for 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:
Philippines
Accuserv Diagnostic Center
Singapore and other Southeast Asian markets; further details are available through its news release
Archerfish Precision Diagnostics
Hong Kong
Codex Genetics
India
Dr. Dangs Lab
Israel
Medical Link
Costa Rica and Mexico
Milenia Labs
Ask the Expert
One of C2N’s newest team members is Rahul Chaudhary, MD, MBA, who has joined as Executive Vice President, Global Strategy and Commercialization. Dr. Chaudhary is a seasoned healthcare executive with global leadership experience spanning clinical diagnostics, medtech commercialization, laboratory medicine, and healthcare strategy. His career has evolved from frontline medical practice to spearheading innovation and transformation programs across multinational diagnostic networks and medtech organizations.
Dr. Chaudhary holds a master’s degree in medical diagnostics and an Executive MBA from Cranfield University UK. He also holds a postgraduate diploma in Digital Business. He has held leadership roles at large medtech and diagnostic organizations including Unilabs, Medicover, Leica Biosystems, ThermoFisher, and PerkinElmer, where he has built and scaled business units, led innovation pipelines, and driven market expansion across the UK, Europe, India, and the Middle East.
We asked him to share some thoughts and perspective.
Please tell us about your background and how these experiences inform your role at C2N.
My background blends scientific training as a clinician, healthcare strategy, and global commercialization, with early career work focused on how data and diagnostics can transform clinical decision-making. Over the years, I’ve had the opportunity to work at the intersection of medical innovation and business growth, helping introduce new diagnostics and precision medicine tools to healthcare systems around the world. These experiences have informed my interests in aligning science, operations, and strategy to drive real patient impact. At C2N, that perspective helps me bridge our groundbreaking science with practical pathways to global access and adoption.
You closely observed C2N before you joined the company. What impressed you the most about its growth and achievements?
What stood out most to me was C2N’s ability to achieve something truly rare in diagnostics: turning cutting-edge research into a clinically viable and scalable solution. The team’s dedication to rigorous science, innovation, and execution while navigating a fast-evolving Alzheimer’s landscape has helped build an extraordinary set of biomarkers that’s reshaping Alzheimer’s detection and other neurodegenerative diseases. What impressed me most was the combination of scientific depth and integrity with a genuine sense of mission. It’s clear that everyone here cares about improving patients’ lives, and that stood out.
What excites you the most about C2N’s future?
C2N is at the forefront of transforming how we detect and manage neurodegenerative diseases. The opportunity to expand access to precise, fluid biomarker testing and to integrate these tools into everyday clinical care for early diagnosis is incredibly exciting. I believe the next chapter for C2N will be a reshaping of how healthcare systems think about precision medicine for AD and brain health more broadly. For example, C2N is looking to bring viable and scalable solutions across the patient management continuum, not just for diagnosis or prognosis, but also for other challenges that patients encounter in their clinical care journey, even when they are in the preclinical or asymptomatic phases of the disease.
What motivated your career path in the medical diagnostics sector?
I’ve always been fascinated by how science can directly improve lives when paired with the right strategy and execution. Diagnostics, to me, sits at that perfect intersection where innovation meets actionable insight, and it is the gateway to better medicine. The ability to help clinicians make earlier, better-informed decisions while working alongside a more informed patient is deeply motivating. Diagnostic medicine is also a space where global access, equity, and impact can converge in a tangible, meaningful way. That combination continues to inspire me every day.
Research Corner
New research has reinforced C2N’s PrecivityAD2 blood test as a highly accurate tool to detect brain amyloid pathology in symptomatic patients. Nature: npj Dementia recently published findings about the PrecivityAD2 test, which aids health care professionals in diagnosing Alzheimer’s disease.
The research states that the PrecivityAD2 blood test demonstrated 91% accuracy, 90% sensitivity and 92% specificity using the CLIA-established single cutoff versus amyloid PET imaging, which health care professionals have traditionally had to rely on to make an Alzheimer’s disease diagnosis. C2N says the outcome confirms the test’s “repeatable, reliable and robust” performance.
The Journal of Personalized Medicine recently published “Implementation of an Alzheimer’s Disease Blood Test: Adoption Experience by Memory Care Specialists in a Multi-Center Study.”
Although recent guidelines and workshop recommendations highlight the important role of Alzheimer’s disease blood tests in patient care, real world implementation of these tests into clinical practice has not been extensively evaluated. The objective of this study was to assess the implementation of the PrecivityAD2 blood test into the clinical workflow of memory care clinics.
The findings showed that the PrecivityAD2 test was clinically useful, easy to incorporate into care, and associated with high health care professional acceptance of the technology. As health systems pivot toward more effective diagnostic tools for facilitating AD diagnosis in clinical practice, these findings provide valuable insights for the broader adoption of AD blood testing in personalized medicine and clinical practice settings.
Where to Find C2N
NAMCP
November 5 – 6, 2025
Las Vegas, Nevada
Human Proteome Organization (HUPO)
November 13 – 14, 2024
Toronto, Canada
Japanese Society for Dementia Research
November 21 – 23, 2025
Niigata, Japan
CTAD
December 1 – 5, 2025
San Diego, California
About C2N Diagnostics, LLC
C2N Diagnostics is a specialty diagnostics company with a vision to bring Clarity Through Innovation™. C2N strives to provide exceptional laboratory services and products in the field of brain health. C2N’s 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. For more information visit www.C2N.com.