C₂N Diagnostics Takes Major Strides in Advancing Brain Health Diagnostics
C₂N Diagnostics, a leader in advanced brain health diagnostics that offers the PrecivityAD™ blood testas an aid to Alzheimer’s disease diagnosis, announced its latest innovative offering that is poised to ultimately enhance care for patients with cognitive impairment: a high-resolution mass spectrometry-based plasma tau multi-analyte assay (p-tau MAA) for Research Use Only (RUO).
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 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 and age 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.
Further details are available at https://c2n.com/news-releases/c2n-diagnostics-introduces-p-tau-multi-analyte-assay-for-research-use-only-to-advance-alzheimers-disease-and-brain-health-field.
C₂N Part of Davos Alzheimer’s Collaborative
We’re proud to be part of the Davos Alzheimer’s Collaborative, which is launching in four continents, six countries and seven health care systems. This global health preparedness initiative is using the PrecivityAD™ test to help improve the accuracy of an Alzheimer’s diagnosis in a timely and efficient manner. DAC uses the PrecivityAD™ test to identify whether patients are likely to have amyloid plaques in the brain, an Alzheimer’s disease hallmark.
C₂N CEO Dr. Joel Braunstein says, “Harnessing the power of advanced diagnostics like our PrecivityAD test at DAC’s pilot sites will accelerate the fight to end Alzheimer’s.”
Ask the Expert
Dr. Mark Monane is a C₂N consultant; he holds an A.B. and an M.B.A. from Columbia University, an M.S. degree in health policy and management from Harvard University, and an M.D. from New York University. He is board certified in Internal Medicine and is a Fellow of the American College of Physicians, Fellow of the American Heart Association, American Geriatrics Society Fellow, and Fellow of the American Board of Medical Quality. He serves as adjunct associate professor at the Ernest Mario School of Pharmacy at Rutgers University.
Q: Please describe what you’ve learned from clinicians about how they are using the PrecivityAD™ test?
A: We’ve learned that the PrecivityAD™ blood test is easy to incorporate into clinicians’ usual care practices in the evaluation of patients with signs or symptoms of cognitive impairment associated with mild cognitive impairment or Alzheimer’s disease (AD). Furthermore, we have learned that the PrecivityAD™ blood test results, known as the Amyloid Probability Score (APS), are associated with changes in clinical decision-making. In a quality assurance study presented at the 2021 Gerontological Society of America Annual Meeting, low APS patients were judged by physicians to have lower AD likelihood post-test and were less likely to be managed with anti-AD drugs, consistent with ruling out AD. High APS patients were judged by physicians to have higher AD likelihood post-test and were more likely to be managed with anti-AD drugs, consistent with ruling in AD. In this manner, the PrecivityAD™ blood test is being used to help clinicians both to rule-in and rule-out AD.
Q: What advancements does the PrecivityAD™ test offer and when should healthcare providers consider using it?
A: In clinical practice, this standard of care in evaluating patients with signs or symptoms of cognitive impairment includes a patient history and physical exam as well as paper and pencil tests. Imaging tests are frequently employed; while CT scans and MRI scans can be useful to rule out non-AD causes of dementia, such tests are poorly correlated with brain amyloidosis, a characteristic finding in AD patients. Until recently, the only method for detecting brain amyloidosis among patients with cognitive impairment was the use of amyloid PET (positron emission tomography) scans or biomarker measurements in cerebrospinal fluid (CSF) obtained through lumbar puncture. Although amyloid PET imaging and CSF biomarkers have significantly improved the detection of brain amyloidosis, there is still a critical need for safe, low cost, less resource-intensive, broadly available, blood-based biomarkers that identify the presence or absence of brain amyloid plaques. The PrecivityAD™ blood test is designed to address this unmet need in clinical care. Going forward, this test may provide value to physicians in their decision-making around novel new therapies recently approved and under late-stage development for Alzheimer’s disease.
Q: What benefits does the PrecivityAD™ test offer to those patients who have traditionally said they are not interested in knowing an early diagnosis?
A: The PrecivityAD™ blood test is not intended per se to convince patients of the benefits of an early diagnosis. That being said, the ease of use of the test, requiring a simple blood draw that is non-invasive as well as easy to access versus other diagnostic tests for Alzheimer’s disease, may make the test more desirable for patient use by removing barriers around testing. According to the Alzheimer’s Association, an early diagnosis of Alzheimer’s disease allows several patient benefits, including access to treatment options, an opportunity to participate in clinical trials, and a chance to prioritize one’s health.
In the News
USA Today covered the PrecivityAD™ test with a story on the front page that also appeared online. C₂N CEO Dr. Joel Braunstein explained the value to healthcare providers of the new validation research published in JAMA Online.
Parade magazine covered Alzheimer’s disease research and intervention, and highlighted the PrecivityAD™ blood test that helps healthcare providers better determine the presence or absence of amyloid plaques in the brain, a hallmark sign of the disease.
We were glad to read in Fierce Biotech details about our innovative p-tau multi-analyte assay for Research Use Only. There was also coverage in Medical Device Network.
Washington University School of Medicine’s Dr. Randall Bateman, a C₂N Diagnostics scientific co-founder, commented in Clinical Research News about the PrecivityAD™ blood test. He explained the research that backs up the test and how it aids healthcare providers in the medical evaluation and care of patients who already have signs and symptoms of cognitive decline.
Of Note
Congratulations to C2N Diagnostics scientific co-founder Dr. David Holtzman for receiving the BrightFocus Foundation Scientific Impact Award at its MIND | SIGHT | CURE: An Evening of BrightFocus awards program. It honored exemplary scientists working with the foundation and showcased some of the world’s most exciting research to end Alzheimer’s, macular degeneration and glaucoma. BrightFocus said “[Dr. Holtzman’s] legacy and leadership in Alzheimer’s research is the foundation for the first blood-based test for Alzheimer’s that is in use in clinical trials today.”
C2N has a new video that explains for individuals how the PrecivityAD™ test can be used by healthcare providers to help in the care and diagnosis of individuals with cognitive impairment.. There’s also an overview video specifically for healthcare providers. In addition, follow the latest details on social media on LinkedIn, Twitter and Facebook.
Join the C2N Diagnostics team at the Alzheimer’s Association International Conference in San Diego, July 31–Aug. 4. The booth is #1001. Multiple oral and poster presentations will offer exciting new insights relating to the PrecivityAD™ test and the p-tau MAA. This will include a late-breaking oral presentation on Sunday, July 31, from 8:00 – 8:45 a.m. PDT (San Diego Convention Center, Ballroom 20A – Hybrid Session #68767) describing the diagnostic performance of C2N’s newest test that combines its plasma amyloid measures with its plasma tau measures. We look forward to seeing you then!
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.
For the latest news and updates, please visit https://precivityad.com.