Latest news with #PrecivityAD2
Business Wire
2 days ago
- Health
- Business Wire
C2N Announces Major Global Expansion, Adds Six New International Partners
ST. LOUIS--(BUSINESS WIRE)-- C2N Diagnostics, LLC ('C2N'), a specialty diagnostics company with a vision to bring Clarity Through Innovation®, is reaching additional global healthcare providers eager to use its PrecivityAD2™ blood test to help diagnose Alzheimer's disease. The PrecivityAD2™ blood test allows healthcare providers to determine 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. Dr. Joel Braunstein, CEO of C2N Diagnostics, says, 'These new international partnerships are intended to broaden access to C2N's innovative Precivity™ portfolio of blood tests in markets facing growing healthcare pressures given aging populations." Share 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: C2N also maintains partnerships with leading labs around the world, including Grupo Fleury, Healius, Mayo Clinic Laboratories, and Unilabs, along with a research collaboration with Mediford. Dr. Joel Braunstein, CEO of C2N Diagnostics, says, 'These new international partnerships are intended to broaden access to C2N's innovative Precivity™ portfolio of blood tests in markets facing growing healthcare pressures given aging populations, a lack of dementia specialists, and inadequate PET infrastructure. These partnerships are a testament to the science and research that have already assisted healthcare providers in delivering a clear picture of Alzheimer's disease pathology to patients and their families in many countries. The growing burden of Alzheimer's disease requires the healthcare system to explore new ways to offer less costly and more accessible diagnostic testing, and we look forward to helping more patients around the world receive an early and accurate diagnosis.' The PrecivityAD2™ blood test involves a simple blood draw from the patient and is intended for patients aged 55 and older with signs or symptoms of cognitive impairment who are undergoing evaluation for Alzheimer's disease or other causes of cognitive decline. PrecivityAD2™ Blood Test is Rigorously Analytically and Clinically Validated; Has High Accuracy The Journal of the American Medical Association (JAMA) published a large clinical care study examining the ability of the PrecivityAD2 blood test algorithm 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 the PrecivityAD2™ test result 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. All C2N's Precivity™ tests are currently performed under the ISO 13485:2016 standard and in the company's CAP accredited, CLIA certified laboratory. 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, and Alzheimer's Association. For more information visit
Business Wire
15-07-2025
- Business
- Business Wire
C2N Diagnostics Expands Portfolio of Blood Tests for Clinical Researchers Studying Alzheimer's Disease and Related Dementias
ST. LOUIS--(BUSINESS WIRE)-- C2N Diagnostics, LLC, a pioneer in advanced diagnostic testing for brain health, announces the launch of two new highly anticipated plasma assays for Research Use Only: C2N eMTBR-tau243 and C2N %p-tau MAA. 'Our introduction of the C2N eMTBR-tau243 blood test and the C2N %p-tau MAA demonstrates C2N's commitment to clinically-relevant innovations and advancing brain health diagnostics," says C2N CEO and President Dr. Joel Braunstein. C2N eMTBR-tau243 (endogenous Microtubule Binding Region) is a unique blood test that selectively detects a specific region of tau; this fragment has been shown to closely track insoluble tau aggregates within neurofibrillary tangles in Alzheimer's disease. C2N cites research that says this may provide the potential to improve the diagnostic evaluation of Alzheimer's pathology in clinical trials, supporting essential disease staging, predicting disease progression and response to treatment, and monitoring treatment efficacy. This new plasma assay builds on the existing C2N eMTBR-tau243 test in cerebrospinal fluid launched by C2N nearly two years ago and is available for Research Use Only. C2N obtained the exclusive rights for these technologies from the Bateman Lab at WashU Medicine. With funding from the GHR Foundation, the C2N team optimized and industrialized these assays using rigorous analytical methods to bring them to their current state. The company aims to integrate the new plasma C2N eMTBR-tau243 assay into clinical routine in the future. C2N Increases Diagnostic Power With C2N %p-tau MAA C2N is also launching a novel p-tau multi-analyte assay (MAA). This assay uses high-resolution mass spectrometry (LC-MS/MS) to precisely quantitate six analytes related to phosphorylated and nonphosphorylated forms of tau (%p-tau181, %p-tau205 and %p-tau217). The C2N %p-tau MAA measures multiple phosphorylated tau forms from a single sample and, therefore, enables greater efficiencies. This test is likewise available for Research Use Only. C2N's LC-MS/MS methodologies enable a ratio of phosphorylated tau divided by non-phosphorylated tau (%p-tau) that previously has been shown to mitigate for confounding factors such as age and medical comorbidities like kidney disease. The Journal of the American Medical Association (JAMA) published a large clinical study that found C2N's PrecivityAD2™ test accuracy was not impacted in the primary care arm of the study despite having patients of older age and with higher prevalence of comorbidities. The company believes the C2N %p-tau MAA and C2N eMTBR-tau243 assays will play a key role in biopharma clinical trials, enabling better assessment of Alzheimer's disease pathology and supporting a precision medicine approach to novel treatment strategies. The assays will cover both early-stage and late-stage tau pathology identification, providing a robust marker for disease identification, staging, and stratification. 'Our introduction of the C2N eMTBR-tau243 blood test and the C2N %p-tau MAA demonstrates C2N's commitment to clinically-relevant innovations and advancing brain health diagnostics, first as Research Use Only tools and then in the form of clinical diagnostic tests,' says C2N CEO and President Dr. Joel Braunstein. 'Patients and families worried about Alzheimer's disease are pressing on the entire healthcare sector for a clearer picture of Alzheimer's disease pathology. We are responding, first for researchers and then for the broader global healthcare provider community.' The Precivity™ line of blood tests currently available clinically to aid healthcare providers in the detection of amyloid plaques in the brain, a pathological hallmark of Alzheimer's disease, and inform medical management and treatment decisions are: PrecivityAD®, PrecivityAD2™, and Precivity-AopE™. 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, and Alzheimer's Association. For more information visit
Ammon
18-05-2025
- Health
- Ammon
US clears first blood test for Alzheimer's detection
Ammon News - The U.S. Food and Drug Administration has cleared Fujirebio Diagnostics' blood test to diagnose Alzheimer's disease, the regulator said on Friday, making the device the first of its kind to detect the brain-wasting condition. Blood tests could speed up diagnosis of the disease and make it easier for more people to access its treatments such as Biogen and Eisai's Leqembi and Eli Lilly's Kisunla, since traditional tests are often costly or uncomfortable. Fujirebio's test, branded as Lumipulse, checks for two proteins in the blood and uses their ratio to help detect signs of amyloid beta plaque, considered a hallmark of the disease, in the brain. Other options to detect Alzheimer's include procedures such as a spinal tap, which requires an invasive puncture to collect spinal fluid, or an expensive PET brain scan that may not be reimbursed by health insurers. "Street expectations for both therapies (Leqembi and Kisunla) are modest" with a slow ramp over the next few years, given the lack of access to neurologists, said Citi analyst Geoffrey Meacham. "An approved blood-based diagnostic is a positive in a disease area that has been starved of game-changing innovation." Biogen has been doubling down on Leqembi but it has failed to live up to lofty expectations due to concerns over cost, efficacy and side effects. In the first quarter, Leqembi brought $96 million in sales, while Lilly recorded $21.5 million in Kisunla sales. Lumipulse and C2N Diagnostics' PrecivityAD2 were the top two performers when compared with four other commercial blood tests for Alzheimer's, according to a study led by researchers at Washington University School of Medicine.
Time of India
17-05-2025
- Health
- Time of India
US FDA clears first blood test for Alzheimer's detection
Bengaluru: The U.S. Food and Drug Administration has cleared Fujirebio Diagnostics ' blood test to diagnose Alzheimer's disease, the regulator said on Friday, making the device the first of its kind to detect the brain-wasting condition. Blood tests could speed up diagnosis of the disease and make it easier for more people to access its treatments such as Biogen and Eisai's Leqembi and Eli Lilly's Kisunla, since traditional tests are often costly or uncomfortable. Fujirebio's test, branded as Lumipulse, checks for two proteins in the blood and uses their ratio to help detect signs of amyloid beta plaque, considered a hallmark of the disease, in the brain. Other options to detect Alzheimer's include procedures such as a spinal tap, which requires an invasive puncture to collect spinal fluid, or an expensive PET brain scan that may not be reimbursed by health insurers. "Street expectations for both therapies (Leqembi and Kisunla) are modest" with a slow ramp over the next few years, given the lack of access to neurologists, said Citi analyst Geoffrey Meacham. "An approved blood-based diagnostic is a positive in a disease area that has been starved of game-changing innovation." Biogen has been doubling down on Leqembi but it has failed to live up to lofty expectations due to concerns over cost, efficacy and side effects. In the first quarter, Leqembi brought $96 million in sales, while Lilly recorded $21.5 million in Kisunla sales. Lumipulse and C2N Diagnostics' PrecivityAD2 were the top two performers when compared with four other commercial blood tests for Alzheimer's, according to a study led by researchers at Washington University School of Medicine. Biogen has partnered with Fujirebio, and Eisai is collaborating with C2N to clinically advance and commercialize blood tests that can detect Alzheimer's risk.
Indian Express
16-05-2025
- Health
- Indian Express
US FDA clears first blood test to detect Alzheimer's disease
The US Food and Drug Administration said on Friday it had cleared Fujirebio Diagnostics' blood test to diagnose Alzheimer's disease, making the test the first of its kind to detect the condition. The blood test, branded as Lumipulse, will initially likely be used to rule out Alzheimer's, with positive results signaling the need for more advanced diagnostics. Alzheimer's, which gradually destroys memory and thinking skills, is characterized by certain changes in the brain, including a buildup of amyloid beta plaques that result in loss of neurons responsible for transmitting information. Fujirebio's device measures two specific proteins in the blood, pTau217 and β-amyloid 1-42, and calculates a ratio between them. This ratio is linked to the presence of amyloid plaques in the brain, which is a key sign of Alzheimer's. Detecting these plaques usually requires a PET brain scan or a spinal tap, which is a more invasive procedure to collect fluid from the spine. Lumipulse only needs a blood draw, making it much easier and more comfortable for patients, the FDA said. 'Alzheimer's disease impacts too many people, more than breast cancer and prostate cancer combined,' said FDA Commissioner Martin Makary. 'Knowing that 10% of people aged 65 and older have Alzheimer's and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.' Lumipulse and C2N Diagnostics' PrecivityAD2 were the top two performers when compared with four other commercial blood tests for Alzheimer's, according to a study led by researchers at Washington University School of Medicine. The FDA has approved Biogen and partner Eisai's Leqembi and Eli Lilly's Kisunla for the treatment of this disease.
