Articles from C2N Diagnostics, LLC

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.

C2N Diagnostics, LLC (“C2N”), a specialty diagnostics company with a vision to bring Clarity Through Innovation®, today announced a $10 million USD investment from Samsung C&T Corporation, Samsung Biologics, Samsung Bioepis, and Samsung Venture Investment Corporation (collectively hereinafter referred to as “Samsung”). C2N says Samsung’s decision bolsters its ability to further scale its clinical laboratory services and advanced diagnostic solutions in the field of brain health.

C2N Diagnostics, LLC (“C2N”), a pioneer in advanced diagnostic testing for brain health, today announced the medical device registration from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (UK MHRA) for the PrecivityAD2™ blood test.

Researchers have determined that healthcare providers increased their ability to make Alzheimer’s disease (AD) probability judgments on their patients when they used the PrecivityAD2™ blood biomarker (BBM) tests from C2N Diagnostics, LLC, which aid them in the detection of amyloid plaques in the brain, a pathological hallmark of AD. This change in clinician-reported probability of AD is also associated with meaningful improvements in downstream clinical care, including changes in plans for AD medications as well as additional brain amyloid testing.

People in Canada concerned about their memory loss or their loved ones’ issues now have a new option to aid in diagnosis. Toronto Memory Program (TMP) is the first clinic in the country to offer the PrecivityAD2™ blood test from C2N Diagnostics, LLC (“C2N”). This blood test allows healthcare providers to determine the presence or absence of amyloid pathology, a known hallmark of Alzheimer’s disease, through a simple, non-invasive approach. Other Canadian clinics are expected to soon join TMP in making the test available.

A respected organization acclaimed for their groundbreaking work with neurological diseases, C2N Diagnostics, LLC, is partnering with The Michael J. Fox Foundation For Parkinson’s Research (MJFF) to better understand the connections amongst neurodegenerative conditions, Alzheimer’s disease (AD) and neuronal a-synuclein disease (NSD), which encompasses Parkinson’s disease (PD), Lewy body dementia (LBD) and REM behavior disorder (RBD).

C2N Diagnostics, LLC (C2N), a world leader in developing Alzheimer’s disease-specific fluid biomarker tests, has received a new $15 million program-related investment from GHR Foundation (GHR) to support the next generation of tests specific to tau tangle pathology. Tau tangles represent an integral component of Alzheimer’s disease pathology and are believed to play an important role in clinical progression of the disease.

C2N Diagnostics, LLC, an international leader with its Precivity blood tests to help diagnose Alzheimer’s disease, aims to create a fully automated, standardized, high resolution liquid chromatography-mass spectrometry (LC-MS) platform to enable the local deployment of the precise innovation at the core of its clinical and research biomarkers in clinical labs around the world.

Unilabs (“Unilabs”), a leading international provider of diagnostic services, and C2N Diagnostics, LLC (“C2N”), a pioneer in advanced diagnostic solutions in the field of Alzheimer’s disease (AD) and related neurological disorders, today announced a major milestone in brain health diagnostics and research across Europe and beyond.

The Journal of the American Medical Association (JAMA) has published a large clinical study examining the ability of C2N Diagnostics, LLC’s (C2N) PrecivityAD2™ blood test to improve the diagnostic accuracy of Alzheimer’s disease (AD) 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 in patients who saw memory care specialists. The PrecivityAD2 test 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.

C2N Diagnostics, LLC (“C2N”), which provides exceptional clinical laboratory services and advanced diagnostic solutions in the field of brain health, has entered into a non-exclusive agreement with Mayo Clinic Laboratories, for inclusion of C2N’s Precivity tests in Mayo Clinic Laboratories’ test offerings to its clients.

C₂N Diagnostics, LLC, a leader in advanced brain health diagnostics, and Eisai Inc., a “human health care company,” have announced Eisai has made an investment of up to 15 million USD in C₂N.

Scientists, clinicians, and others taking part in the 16th Clinical Trials on Alzheimer's Disease (CTAD) conference learned the latest insights about C2N Diagnostics, LLC’s Precivity™ line of blood tests to facilitate earlier and more accurate diagnosis of Alzheimer’s disease pathology by healthcare providers. CTAD attendees heard about clinical and analytical data relating to C2N’s proprietary portfolio at 10 sessions and from three scientific posters.

C2N Diagnostics, LLC (C2N), a leader in advanced brain health diagnostics, announced new findings that its blood biomarkers Aβ42/Aβ40 (amyloid-beta) and p-tau217/np-tau217 (%p-tau217, or phosphorylated tau-217 divided by non-phosphorylated tau-217)1 are helpful in improving the speed and efficiency of anti-amyloid prevention trials in individuals with pre-clinical Alzheimer’s disease. Both of these biomarkers are included in the company’s commercially available Precivity™ blood tests, which help healthcare providers determine the presence of amyloid plaques in the brain, a hallmark sign of Alzheimer’s disease, and aid in medical management and treatment decisions.

C2N Diagnostics, a leader in advanced brain health diagnostics, is responding to pharmaceutical industry interest by introducing a much-desired, proprietary biomarker test for Research Use Only (RUO) that can measure the microtubule binding region of tau (MTBR-tau). This analyte measurement was engineered with the intention of uniquely detecting the presence and burden of neurofibrillary “tau” tangles (NFTs) comprised of aggregated tau proteins in the brain and as a potential alternative to invasive, costly, and often inaccessible tau PET tracers.

C2N Diagnostics, a leader in advanced brain health diagnostics, is marking World Alzheimer’s Day by highlighting the growing international availability of the PrecivityAD2 blood test, a clinical care assay that helps healthcare providers identify amyloid plaques in the brain, which are recognized as key indicators of Alzheimer’s disease. Research has shown that PrecivityAD2 results closely match those from PET scans and spinal taps, the long-standing Alzheimer’s disease diagnostic tools that are seen as costly, invasive and not widely available.

C2N Diagnostics, a leader in advanced brain health diagnostics, today announced the release of the PrecivityAD2 blood test, a clinical care assay that meets the standard of care with currently available PET scans and cerebrospinal fluid tests. This blood test is designed to alleviate the bottleneck and unmet needs of healthcare providers and patients in evaluating patients with signs and symptoms of Alzheimer’s disease (AD) and other causes of cognitive decline.

C2N Diagnostics, a leader in advanced brain health diagnostics, says new research posted in the online version of Annals of Clinical and Translational Neurology (and soon in print form) affirms the clinical utility of its PrecivityAD® blood test, which healthcare providers use to help diagnosis Alzheimer’s disease (AD). The findings are believed to represent the first prospective, published evidence that clinicians use novel blood biomarker testing in a way that improves patient care management.

C2N Diagnostics today announced the Annals of Clinical and Translational Neurology has published online a new study that further demonstrates the Amyloid Probability Score (APS), used in the company’s PrecivityAD® blood test to help healthcare providers better diagnose Alzheimer’s Disease (AD), is a reliable marker of brain amyloidosis among individuals aged 60 years and older with cognitive impairment (current Intended Use population). The research also shows a person’s APS score is a potential indicator of individuals actively accumulating amyloid, a dynamic and evolving process characteristic of progressive AD pathology.

C2N Diagnostics, LLC, a leader in advanced brain health diagnostics, today announced it has received a $15 million program-related investment from GHR Foundation. This financing, an expansion of GHR’s initial $20 million program-related investment to C2N in early 2020, signifies the foundation’s deep commitment to the company and to reducing the global burden of Alzheimer’s disease through early detection and prevention.

C2N Diagnostics, LLC (“C2N”) provided today a recap of the multiple presentations at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) Congress, November 29 – December 2, 2022, in San Francisco, highlighting the clinical utility and performance of the company’s blood-based biomarkers for the evaluation of patients with cognitive impairment.

C2N Diagnostics, LLC (“C2N”), a leader in advanced brain health diagnostics, today announced at the Clinical Trials on Alzheimer’s Disease (CTAD) 2022 EU/US Task Force on Blood Biomarkers its next generation test to aid in the diagnosis of Alzheimer’s disease (AD): the PrecivityAD2™ blood test. With an anticipated launch in Q1 2023, the test is expected to facilitate earlier and more accurate diagnosis of AD pathology. The test uses precise and robust mass spectrometry-based measurements of two key plasma proteins implicated in the AD process: tau and amyloid beta.

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.

A group of distinguished Alzheimer’s disease researchers has affirmed, in a new study published online in the journal Brain, the superiority of the methods that are the basis of C2N Diagnostics’ new p[hospho]-tau217 ratio test. Currently available as a unique research tool in Alzheimer’s clinical studies, C2N’s p-tau217 ratio test is nearing completion of development as a clinical lab test that will help healthcare providers better diagnose Alzheimer’s disease, particularly when combined with amyloid beta (Aβ) measures from C2N’s existing PrecivityAD™ clinical blood test.

C2N Diagnostics continues to build on its mission to provide exceptional laboratory services and products in the field of brain health. Its latest success is the news that the Accreditation Committee of the College of American Pathologists (CAP) has awarded accreditation to C2N’s lab based on results of a recent on-site inspection.

Four separate research reports presented at premier Alzheimer’s disease and aging conferences add to the increasing set of details about the accuracy and clinical usefulness of the PrecivityAD™ blood test from C2N Diagnostics. The 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 (AD).

A peer-reviewed journal has published the first research paper to state that the PrecivityAD™ blood test “can accurately identify brain amyloid status based on a single blood sample.” The research paper in Molecular Neurodegeneration adds that the test’s “excellent performance” for Alzheimer’s disease (AD) diagnosis allows for “improved medical decision making and management, streamlined AD clinical trial enrollment, and better identification of who may benefit from an AD specific therapy.”