C₂N Diagnostics Marks Two Years of PrecivityAD® Blood Test Accomplishments
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C₂N Diagnostics, which brings Clarity Through Innovation™ with laboratory services and leading products in the brain health field, recognizes an important milestone: The two-year anniversary of it being the first to offer a widely accessible blood test to aid clinicians in Alzheimer’s diagnosis.
The company boldly launched the PrecivityAD blood test during the height of the COVID pandemic in October 2020. While NBC News noted it “may have flown under the public's radar in 2020” due to the pandemic, the PrecivityAD test showed that “science did not stop.”
During the past 24 months, independent research journals have published numerous validation studies that have resulted in additional praise. Molecular Neurodegeneration was the first to distribute a research paper that stated the PrecivityAD blood test “can accurately identify brain amyloid status based on a single blood sample.” This was followed by Clinica Chimica Acta publishing analytical validation results and JAMA Network Open publishing results of two independent studies that demonstrated the high diagnostic performance of the PrecivityAD test.
Additional independent research published in Journal of the American Medical Association Neurology with findings from BioFINDER’s large comparison of blood plasma amyloid-beta assays. One of the assays included in the study was the liquid chromatography-mass spectrometry (LC-MS/MS) assay that Dr. Randall Bateman (a co-founder of C2N) and his laboratory developed at Washington University that underpins the PrecivityAD blood test. The international research group found it was superior to the other amyloid beta tests studied for identifying amyloid pathology in the brain. More recently, another important independent research study published in Brain, which included coauthors Drs. Nicolas R Barthélemy, Yingxin He, and Randall Bateman from Washington University, found their p[hospho]-tau217 ratio LC-MS/MS blood test was superior to nine other tau blood tests, including various p-tau181, p-tau217, and p-tau231 immunoassays for both identifying abnormal brain amyloid status and also for predicting future progression to Alzheimer’s dementia. This p-tau217 test, which has been successfully transferred over to C2N for industrial scale-up, automation, and standardization is making exciting commercial development progress in various intended use applications.
These independent studies occurred as the landmark AHEAD study announced it is using C2N’s blood-based biomarkers to screen for the presence of amyloid plaques in the brain, a hallmark sign of Alzheimer’s disease. This is part of a promising clinical trial occurring at 75 research centers aimed at preventing memory loss using lecanemab, an anti-amyloid antibody therapy developed by Eisai Co. Ltd, and Biogen Inc., that recently demonstrated in a large clinical study (Clarity AD) delays in cognition decline among individuals with early Alzheimer’s disease.
The PrecivityAD test continued to reach more people when the Davos Alzheimer’s Collaborative launched its international flagship program to improve early disease detection. This initiative is using the test as a critical diagnostic aid for proper Alzheimer’s diagnosis at seven health care systems and six countries around the world.
Back at C2N’s St. Louis headquarters, the Accreditation Committee of the College of American Pathologists (CAP) awarded accreditation to the company’s lab based on an on-site inspection that yielded zero inspection deficiencies. It also achieved ISO 13485:2016 certification for its quality management system, and the PrecivityAD test earned the CE Mark from the European Union.
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Impressive Results Lead to Further Growth
C2N’s success has furthered strengthened its belief in its mission to become a world leader in providing best-in-class diagnostic products and services for the benefit of patients. Toward that goal, it recently introduced the p-tau multi-analyte assay for Research Use Only. Shown at this year’s Alzheimer's Association International Conference, combining C2N’s plasma Aβ42/40 ratio assay with p-tau217 ratio assay yields a blood test with comparable accuracy as the current gold standards for Alzheimer’s brain pathology detection (amyloid PET imaging or cerebrospinal fluid tests), albeit at a lower cost, with less invasive sampling needs, and much lower complexity.
This promising technology progress is stimulating many creative partnerships for the company, including with leading companies like Eisai in the U.S., Healius in Australia, and Grupo Fleury in Brazil.
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Patients Grateful for Answers Thanks to C2N’s PrecivityAD Test
These accomplishments have real world consequences for patients and families, some of whom have recently shared their stories with the public.
NJ.com spoke with a senior who shared that he knew his memory was slipping and sought answers to the cause. His PrecivityAD test result helped his doctor officially diagnose him with Alzheimer’s, which now allows him to assess potential care options.
AARP The Magazine reported on Shelby Hileman, who also received an Alzheimer’s diagnosis after her doctor reviewed her PrecivityAD blood test result. Now, Hileman is eligible to explore participating in clinical trials for dementia drugs.
In a TV story, a wife shared why her husband decided to take the PrecivityAD blood test after his doctor recommended it. He's dealing with memory loss and other cognitive issues; they feared he had Alzheimer’s disease.
Dr. Joel Braunstein, C2N’s CEO, says, “We’re honored to provide breakthrough diagnostic tools to the brain health sector. A clinical need exists, and few ambitions are as fulfilling to our talented team to know that they are making a difference in patients’ lives. We have heard from many healthcare providers, patients and families that our blood biomarkers have given them the answers they need to understand difficult situations. Our work is only beginning; however, the advancements we’ve brought to market in a short period of time provides us momentum for success and expansion in the future.”
Dr. Howard Fillit is Co-Founder and Chief Science Officer of the Alzheimer’s Drug Discovery Foundation (ADDF), which provided funding to support the development of the PrecivityAD test as part of its biomarker research initiatives. He says, “Our congratulations to the entire C2N team on this two-year achievement. The PrecivityAD blood test has succeeded in putting the early and specific diagnosis of Alzheimer’s disease into the mainstream of physician practice. It has also demonstrated its important role in clinical trials by making screening enrollment and the monitoring of drug effects less expensive and more efficient.”
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Ask the Expert
For Ask the Expert, we talk to Mary Holubasch, C2N’s CLIA General Supervisor at the St. Louis lab.
Q: As we’re marking the company’s two-year anniversary, please share with us your memories of the beginning days and the incredible growth that has taken place.
A: My first day at C2N in 2007 was spent with Dr. Tim West, the company’s Vice President of Research and Development, walking into a completely empty room. That room required build-out into a fully functional lab, from the purchase of our first beaker to our first computer and mass spectrometer. We are now a fully operational organization with two lab sites and have grown from an onsite team of two to a fully operational organization with two fully staffed complex labs. Our testing platform also has grown substantially, going from one CSF amyloid beta assay to a panel of assays that includes plasma tests and different protein biomarkers to help identify the presence of Alzheimer’s disease.
Q: You serve as CLIA General Supervisor. What does that entail and how does it fit into the entire quality operation of the lab?
A: My certification is in medical technology, so my background is performing bench assays under CLIA guidelines. As supervisor, I mentor and train new testing personnel and make sure all our processes are conducted in a regulated way to ensure our results are accurate and reproducible.
Q: How does your role fit into the superior lab services that are in operation?
A: My heart is still in laboratory bench testing, so I’ve never drifted too far away from performing the assays. I was on the development team for all our assays and continue to work on test improvements and troubleshooting.
Q: Where do you see the company going in the near future?
A: I can see us increasing our lab space, partnering with labs throughout the world to perform our biomarker tests, and developing more biomarkers that will assist in the comprehensive care of people who have disease or are at high risk. It’s an extraordinary and important time to be working in the dementia field, as we expect new disease-modifying treatments to come to market soon. Accurate diagnosis will be necessary for the right people to receive these treatments. Research in this space will also increase, which will allow us to keep providing innovative new biomarkers for use in important studies.
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Research Corner
We’re highlighting prominent clinical research studies that have utilized the PrecivityAD blood test:
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AHEAD3-45: The AHEAD Study is funded by the National Institutes of Health and several philanthropic organizations, as well as Eisai, the company that makes the investigational treatment used in the study (Lecanemab). It’s being conducted by the NIH-funded Alzheimer’s Clinical Trial Consortium (ACTC), a network of leading academic Alzheimer’s research centers. The study is coordinated by the University of Southern California’s Alzheimer’s Therapeutic Research Institute (ATRI), Brigham and Women’s Hospital, Massachusetts General Hospital, and Harvard Medical School. Cooperative agreement number: R01AG054029 (A3), R01AG061848 (A45): https://clinicaltrials.gov/ct2/show/NCT04468659
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Upcoming
Meet with the C2N Team at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference in San Francisco, November 28 – December 2. Stay tuned for more details about the exciting new data that will be shared at the meeting regarding C2N’s tests.
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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.
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