C₂N Opens State-of-the-Art CLIA Lab in St. Louis as Alzheimer’s Disease Blood Diagnostic Test Bests Others in Independent Comparison Studies Published in JAMA Neurology
The company is using this start-of-the-art federally regulated CLIA lab for its clinical diagnostic testing services.
On World Alzheimer’s Day, Missouri leaders and economic development officials praise C₂N Diagnostics for deciding to continue to grow its St. Louis-based company which is receiving international recognition for developing and accelerating novel diagnostics and therapies for Alzheimer’s disease.
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C₂N Diagnostics has expanded its lab facilities to 13,320 square feet in the Cortex Innovation Community at 4340 Duncan Ave. in St. Louis. The company uses this start-of-the-art federally regulated CLIA lab for its clinical diagnostic testing services. (Photo: Business Wire)
C₂N Diagnostics has expanded its lab facilities to 13,320 square feet in the Cortex Innovation Community at 4340 Duncan Ave. The company is using this start-of-the-art federally regulated CLIA lab for its clinical diagnostic testing services. All research and development activities remain at C2N’s existing facility, which is a short distance away from the new facility.
C₂N’s PrecivityAD™ test is a breakthrough blood test intended for use in patients with cognitive impairment. The test helps physicians determine the presence or absence of amyloid plaques in the brain, a hallmark sign of Alzheimer’s disease.
“Alzheimer’s is one of the most prevalent and costly diseases in America, with someone newly diagnosed every 60 seconds,” says U.S. Sen. Roy Blunt (Mo.). “I congratulate Drs. Holtzman and Bateman and C₂N Diagnostics for their lab expansion and commitment to Missouri. Their work has the potential to significantly change the trajectory of Alzheimer’s diagnosis. As the top Republican on the Senate Appropriations Subcommittee that funds health programs, I have been proud to work with my colleagues to make Alzheimer’s research a priority — more than quadrupling funding in this area over the past six years. To see part of that funding help lead to a breakthrough like this is an incredible testament to the importance of investing in medical research. I’m excited to see our state’s researchers leading the nation with groundbreaking innovations like the Alzheimer’s blood test and look forward to seeing what’s ahead.”
“St. Louis has been an ideal place to launch and grow C₂N Diagnostics, and we’re very proud to be able to advance the community’s interest in biosciences by investing here,” says Joel Braunstein, M.D., CEO. “We appreciate the support we’ve received from state and city leaders, the St. Louis Economic Development Partnership, as well as the medical community in adding to St. Louis’ reputation as a leading home for innovative companies.”
In addition, The Journal of the American Medical Association Neurology published findings from BioFINDER’s large comparison of blood plasma amyloid-beta assays. One of the types of assays included in the study was the liquid chromatography–mass spectrometry (LC-MS/MS) assay that Dr. Bateman and his laboratory developed at Washington University that underpins the PrecivityAD™ blood test. The international research group found it performed the best out of seven assays, including in the measurement of phosphorylated tau-217, another Alzheimer’s biomarker.
The JAMA Neurology piece also highlights confirmation of the BioFINDER results based on blood samples analyzed from the Alzheimer Disease Neuroimaging Initiative, an eminent longitudinal cohort study in North America that has been tracking patients since 2004.
The paper says that “plasma Aß42/40 quantified with the IP-MS-WashU approach showed significantly better performance than the immunoassays.” It adds that the “IP-MS blood test for Aß developed by Washington University can now be used in clinical care in US,” which is indeed occurring through C₂N’s PrecivityAD™ test.
C₂N’s recent developments build on the following successes:
- Clinicians in 49 states, the District of Columbia and Puerto Rico have all granted C₂N Diagnostics a CLIA certificate to conduct such testing.
- Best Startup named C₂N Diagnostics one of the “Best Missouri Biotechnology Companies and Startups". Best Startup says it picks startups and companies that are “taking a variety of approaches to innovating the Biotechnology industry, but are all exceptional companies well worth a follow.”
- NBC News put the PrecivityAD™ blood test on its list of top 2020 medical accomplishments and The Scientist selected it as one of the biggest science news stories of the year.
- The Journal of the Alzheimer's Association included details about the National Institutes of Health’s National Institute on Aging (NIA) support of C₂N in developing PrecivityAD™. The paper explained the NIA Small Business Innovation Research grants and how PrecivityAD™ is “the first amyloid blood test to become available to doctors, who can send blood samples to C2N’s lab to analyze blood for amyloid.” https://alz-journals.onlinelibrary.wiley.com/doi/epdf/10.1002/alz.12392
About C2N Diagnostics, LLC
C₂N Diagnostics’ vision is to bring Clarity Through Innovation™. It focuses its therapeutic discovery efforts around mechanism-based approaches to prevent or stop the progression of human neurological disorders. Diagnostic efforts revolve around bringing accurate, widely accessible, and cost-effective blood tests to the clinic for the betterment of patient care and brain health monitoring. For more information visit www.C2N.com.
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