C2N Diagnostics Says FDA’s Approval of Donanemab Highlights Its Role in Helping to Determine Alzheimer’s Disease Pathology
2024年7月3日 - 7:34AM
ビジネスワイヤ(英語)
C2N Diagnostics, a leader in advanced brain health diagnostics,
is closely tracking today’s decision by the U.S. Food and Drug
Administration to approve donanemab for treatment of early
Alzheimer's disease. Researchers used C2N’s Precivity-p-tau217
blood biomarker in its Phase 3 clinical trial and analysis for
donanemab, which was highlighted in the article “Donanemab in Early
Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized
Clinical Trial1” in the Journal of the American Medical
Association.
Eli Lilly and Company says donanemab significantly slowed
cognitive and functional decline in people with early symptomatic
Alzheimer's disease. Exploratory outcomes included changes in
plasma p-tau217 at 76 weeks and other time-based analyses. Lilly
stresses that donanemab is not a cure for Alzheimer’s disease, but
it has been shown to slow disease progression in clinical
trials.
C2N believes it is uniquely positioned to support the medical
community in confirming Alzheimer’s disease pathology with its
Precivity™ portfolio of tests. The PrecivityAD2™ blood test is 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 and other causes of cognitive
decline.
The PrecivityAD2 and the PrecivityAD® 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.
Dr. Joel Braunstein, CEO of C2N Diagnostics, says, “The
Precivity™ tests continue to show their high accuracy and represent
an important tool for the clinical research community to help
evaluate emerging treatment strategies. Our experience with
clinical studies evaluating donanemab and lecanemab, which received
FDA approval last year, shows that we’re delivering on our promise
to provide exceptional laboratory services and products in the
field of brain health. C2N is proud to assist in bringing new
innovative treatments to patients.”
The PrecivityAD2™ test uses a proprietary Amyloid Probability
Score 2 (APS2) result that incorporates precise measurements of
p-tau217/np-tau217 Ratio and Aβ42/40 Ratio into an analytically and
clinically validated algorithm. The APS2 result correlates
significantly and more robustly with brain amyloid pathology as
measured by PET scan than to the individual Aβ42/40 and
phosphorylated tau biomarker measurements considered
separately.
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.
1 Sims JR, Zimmer JA, Evans CD, et al. Donanemab in Early
Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized
Clinical Trial. JAMA. 2023;330(6):512–527.
doi:10.1001/jama.2023.13239
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COMPANY CONTACT: Joni Henderson JHenderson@c2n.com
314-464-0009
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