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C2N Diagnostics Introduces P-tau Multi-Analyte Assay for Research Use Only to Advance Alzheimer’s Disease and Brain Health Field

  • P-tau Multi-Analyte Assay (MAA) Uses High-Resolution Mass Spectrometry to Precisely Quantitate Four Analytes Related to Phosphorylated and Nonphosphorylated Forms of tau217 and tau181
  • P-tau MAA Provides Innovative Tool for Industry and Clinical Researchers to Use in Their Alzheimer’s and Brain Health Studies
  • P-tau MAA is Designed to Aid in Screening Individuals for Participation in Clinical Research, Better Understanding Disease Biology and Studying Investigational Treatment Responses

C2N Diagnostics, a leader in advanced brain health diagnostics that offers the PrecivityAD blood test as an aid to Alzheimer’s disease diagnosis, announced its latest innovative offering for enhancing care in brain health: a high-resolution mass spectrometry-based plasma tau multi-analyte assay (p-tau MAA) for Research Use Only (RUO).

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“GHR is committed to our deep partnership with C2N as we together reimagine what’s possible in the prevention and treatment of Alzheimer’s disease.”

This assay uses a small sample of blood to precisely and simultaneously measure different phosphorylated and nonphosphorylated forms of the tau protein, including forms with phosphorylation at the tau217 and tau181 sites. The assay draws upon prior discoveries by medical researchers that complex interactions among abnormal tau and beta-amyloid proteins and several other factors play a vital role in Alzheimer’s-related brain changes.

The p-tau MAA’s RUO availability allows leading industry and clinician researchers to further study ways to better diagnose, monitor investigational treatment responses and understand the underlying biological mechanisms of Alzheimer’s disease. C2N believes this RUO development broadens the panel of cutting-edge biomarkers that will ultimately aid in disease diagnosis and brain health evaluations.

C2N’s current clinically available PrecivityAD™ test combines accurate measurements of the amyloid beta 42 and 40 peptides in plasma along with ApoE proteotype to calculate an individual’s likelihood of amyloid plaques in the brain. C₂N and other researchers have found the PrecivityAD™ blood test results to be an accurate indicator of Alzheimer’s disease pathology among people with signs and symptoms of cognitive decline.

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Plans to Integrate p-tau MAA with C2N’s Advanced Clinical Diagnostic Services

Under C2N’s p-tau MAA RUO, researchers can evaluate and characterize its ability to precisely identify Alzheimer’s pathology at early stages of disease. Its power is uniquely amplified when used in connection with C2N’s plasma amyloid beta 42/40 ratio assay, which has already received high diagnostic performance marks across multiple clinical studies.

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Dr. Howard Fillit, co-founder and chief science officer at the Alzheimer’s Drug Discovery Foundation, says, “We are encouraged by the results from C2N’s existing PrecivityAD™ blood test measurements and excited by the addition of the p-tau MAA. In the future, we expect that a combination of tests, including C2N’s, that each measure different aspects of Alzheimer’s biology will allow more healthcare providers to offer early Alzheimer’s diagnosis to patients with the aid of validated blood test results. This will also decrease the need for more invasive and expensive tests, such as cerebrospinal fluid tests and amyloid or tau PET imaging. The p-tau MAA can also serve as a new tool to help researchers in their clinical studies.”

Dr. Joel Braunstein, C2N’s CEO and co-founder, says, “This development builds on our team’s history of providing exceptional laboratory services and products in the field of brain health. Our team has worked tirelessly to achieve this p-tau advancement that adds to our existing efforts to bring accurate, widely accessible and cost-effective blood tests to the clinic for the betterment of patient care. We look forward to sharing important data about the performance of our p-tau MAA test at upcoming medical meetings and in peer-reviewed publications.”

“This remarkable development by C2N brings the field one step closer to the goal of preventing Alzheimer’s disease by screening healthy adults and providing treatments prior to cognitive symptoms,” says Fred Miller, Alzheimer’s Initiative lead and chief operating officer of GHR Foundation. “GHR is committed to our deep partnership with C2N as we together reimagine what’s possible in the prevention and treatment of Alzheimer’s disease.”

The p-tau MAA development occurs as C₂N Diagnostics has earned ISO 13485:2016 Certification for its quality management system, College of American Pathologists (CAP) accreditation and Clinical Laboratory Improvement Amendments (CLIA) certification.

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