JAMA Publishes Landmark Clinical Study Showing C2N Diagnostics’ PrecivityAD2™ Blood Test Markedly Improves Accuracy of AD Diagnosis in Both Primary Care and Specialized Memory Care
2024年7月28日 - 9:12PM
ビジネスワイヤ(英語)
PrecivityAD2 Test Delivers Confirmatory
Diagnostic Performance That Is Comparable To CSF Biomarkers and
Amyloid PET To Identify Presence or Absence of Brain Amyloid
Pathology
Top-line Study Results To Be Presented During
Opening Day at the Alzheimer’s Association International Conference
(AAIC) 2024
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.
The article, “Blood Biomarkers to Detect Alzheimer’s Disease in
Primary Care and Secondary Care,” also states that these results
involving over 1,200 patients were substantiated despite a
relatively high rate of medical comorbidities such as
cardiovascular disease, high cholesterol, chronic kidney disease,
and diabetes among prospectively enrolled patients in both primary
and secondary care.
Dr. Oskar Hansson, Professor of Neurology at Lund University in
Sweden and senior author of the article, will present the top-line
study findings on the opening day of AAIC 2024 in Philadelphia.
He’ll explain that primary care physicians diagnosed Alzheimer’s
disease pathology accurately only 61% of the time when they relied
on the standard of care involving a clinical examination, cognitive
testing and a CT scan.
The PrecivityAD2 test involves a single blood draw sample and
then uses high-resolution mass spectrometry to precisely measure
proteins in the blood that indicate the likelihood of amyloid
plaques in the brain, a pathological hallmark of AD. It relies on a
rigorously-validated algorithm that combines plasma Aβ42/40 and
p-tau217/np-tau217 (%p-tau217) ratios. The test provides clear
answers with positive or negative results that reflect a high or
low likelihood of the presence of brain amyloid pathology.
Dr. Sebastian Palmqvist, Associate Professor of Neurology at
Lund University and lead author of the article says, “The results
of this study support the idea that a high-performing blood test
has the potential to revolutionize the diagnostic work-up of
Alzheimer’s disease in primary care. Primary care settings are
where the vast majority of individuals with cognitive symptoms will
be managed in the coming decades as secondary and tertiary
healthcare providers do not have the resources to handle this
patient volume.” He noted that additional studies of clinical
utility are needed.
The study outcome meets the recommended performance criteria
from the recent Global CEO Initiative on Alzheimer’s Disease (CEOi)
blood biomarker working group, which developed an impactful guide
to significantly elevate the quality of blood biomarker tests for
patients with cognitive concerns.
Research Process, Findings and Implications
To compare diagnosis using clinical assessment alone to blood
biomarker testing, the patients in the two prospective cohorts
underwent standard primary care or secondary care (dementia
specialists) clinical evaluation. Providers were then asked in a
questionnaire if they thought their patient had Alzheimer’s
disease. The blood test and the physicians’ estimation were
compared to a clinical, biomarker-verified Alzheimer’s disease
diagnosis.
Specifically, the researchers found that the PrecivityAD2 test
output known as Amyloid Probability Score 2 demonstrated an
accuracy at or above 90% for the total pooled cohort. Using a two
cutoff-approach resulted in even higher accuracies and especially
positive predictive values of 97-99% in patients with cognitive
impairment, meaning that a positive blood test result really equals
actual presence of AD pathology in the brain.
Dr. Joel Braunstein, C2N’s CEO and co-founder, says, “This
landmark research shows how our consistent, robust, and
high-performing blood tests are providing a clear picture of
Alzheimer's disease pathology. The test performed the same in
primary care and specialty memory care, and it was highly accurate
regardless of patients’ clinical presentation and medical
comorbidities. The outcomes should eliminate the need for invasive
lumbar punctures and costly amyloid PET scans for most patients
while also helping to reduce the time to an accurate diagnosis on a
global scale. Our full line of Precivity tests supplement the
diagnostic work of healthcare providers in primary and secondary
care settings. We’re all focused on reducing the delays in timely
diagnosis and in the initiation of treatment for appropriate
patients. This research highlights how blood tests can help in
settings around the world.”
Dr. Braunstein pointed out that the availability of new amyloid
lowering immunotherapies is anticipated to increase the number of
patients seeking care for concerns about cognition and memory
decline that may be associated with early-stage AD.
C2N has recently partnered with various leading global
laboratories to increase access to the Precivity portfolio of blood
tests, including Grupo Fleury in Brazil, Healius in Australia,
Mediford in Japan (for research) and Mayo Clinic Laboratories
(global). The company says additional global partnerships are
expected soon.
The Precivity blood tests are intended for use in patients aged
55 and older with signs or symptoms of mild cognitive impairment or
dementia who are undergoing evaluation of Alzheimer’s disease or
dementia.
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. Over 30,000
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, Alzheimer’s Association and BrightFocus Foundation. For
more information visit www.C2N.com.
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MEDIA CONTACT: Adam Shapiro Adam.Shapiro@ASPR.bz
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COMPANY CONTACT: Joni Henderson JHenderson@c2n.com
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