- The Elecsys® tTau/Abeta42 ratio helps clinicians
define Alzheimer's disease (AD) biologically and expands Roche's AD
CSF portfolio to include biomarkers for all three main pathological
processes of Alzheimer's: amyloid plaques, tau tangles and
neurodegeneration.
- Confirmation of amyloid pathology via CSF FDA-cleared
Alzheimer's biomarker testing or amyloid positron emission
tomography (PET) is recommended in the appropriate use
recommendations for new and emerging disease-modifying therapies
(DMTs) shown to slow down cognitive decline when administered in
early-disease stages.
- Scalable and economical, Elecsys AD CSF assays can be added
to any of Roche's widely available cobas® fully
automated immunoassay analyzers, giving patients broad access to
high-quality testing in a timely manner.
INDIANAPOLIS, June 27,
2023 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX:
RHHBY) today announced that its Elecsys® beta-Amyloid (1-42) CSF II
(Abeta42) and Elecsys® Total-Tau CSF assays (tTau) have
received U.S. Food and Drug Administration (FDA) 510(k) clearance.
The Elecsys AD CSF Abeta42 and tTau assays (used as a tTau/Abeta42
ratio) measure two biomarkers of Alzheimer's pathology,
beta-amyloid and tau proteins, in adults ages 55 and older being
evaluated for the disease.
The Elecsys® tTau/Abeta42 ratio helps
clinicians define Alzheimer's disease (AD) biologically...
Currently, the diagnosis of Alzheimer's is largely one of
exclusion (ruling out non-Alzheimer's causes of symptoms) based on
a number of evaluations, including various cognitive exams, routine
laboratory tests and neuroimaging with a head MRI or CT scan.
Obtaining an accurate diagnosis can take years,1 and one
based on clinical criteria is reached only 70%-80% of the
time.2 Additional evaluations with biomarkers specific
to Alzheimer's improve medical decisions, as they can identify
underlying pathological changes early in the disease.
Roche's FDA-cleared Alzheimer's tests in the U.S. include two
ratios comprising three assays. Both ratios include Abeta42.
The Elecsys® beta-Amyloid (1-42) CSF II (Abeta42)
and Elecsys® Phospho-Tau (181P) CSF (pTau181) assays
(used as a pTau181/Abeta42 ratio) that received FDA 510(k)
clearance in 2022 and Elecsys beta-Amyloid (1-42) CSF II and
Elecsys Total-Tau CSF assays (the tTau/Abeta42 ratio) are
reflective of the main Alzheimer's pathologies and help clinicians
more completely define the disease biologically, facilitating a
diagnosis of inclusion.
"With the increasing likelihood of broad availability of new,
Alzheimer's disease–specific therapies, now is the time for
healthcare professionals and institutions to prepare to meet the
demand for diagnostic methods to streamline and accelerate the path
to the right treatment, at the right time, for people with
Alzheimer's," said Brad Moore,
president and CEO of Roche Diagnostics North America. "An early and
accurate diagnosis can help patients, caregivers and physicians
determine a path forward, and the Elecsys CSF assays support
diagnosis at early disease stages, when treatment is most
effective."
Progression of Alzheimer's occurs over a continuum with symptoms
worsening over time. The Alzheimer's Association estimates that,
each day, more than 2,000 people ages 65 and older may transition
from mild dementia due to Alzheimer's to moderate dementia due to
Alzheimer's.3
The appropriate use recommendations for new and emerging
Alzheimer's medicines call for confirmation of amyloid
pathology.4 The only FDA-cleared methods to confirm
amyloid pathology are CSF tests and PET scan imaging.
The Elecsys AD CSF assays are concordant with amyloid PET scan
imaging5 and have the potential to provide a more
affordable and accessible routine option to confirm the presence of
amyloid pathology in the brain. They also offer detection of both
amyloid and tau biomarkers from one draw, with no radiation and
potential to detect Alzheimer's pathology in early stages of
disease.6 The high cost, limited availability and
patient exposure to radioactivity limit use and accessibility to
PET. In addition, evaluating both amyloid and tau Alzheimer's
biomarkers using PET requires multiple appointments and procedures,
and increases radiation exposure.
The Elecsys pTau181/Abeta42 ratio is currently available. The
new Elecsys tTau/Abeta42 ratio will be available in Q4 2023.
Roche's Elecsys AD CSF assays are already registered in 46
countries worldwide, including those accepting the CE mark. In
July 2022, Roche also announced that
the FDA granted Breakthrough Device Designation to its
Elecsys® Amyloid Plasma Panel, an innovative, minimally
invasive and easily accessible solution that enables the
measurement of Alzheimer's biomarkers from a blood sample. These
assays are still in development, but once they are available, they
could be used to streamline patients toward confirmation of amyloid
pathology using the Elecsys AD CSF assays.
About the Elecsys® beta-Amyloid (1-42) CSF II
(Abeta42) and Elecsys® Total-Tau CSF (tTau)
assays
Alzheimer's disease's key features are accumulation in the brain
of abnormal amyloid beta and tau proteins, followed by
neurodegeneration. The Elecsys beta-Amyloid (1-42) CSF II and
Total–Tau CSF assays accurately and reliably measure the
beta–Amyloid (1–42) and Total–Tau concentrations in CSF in adult
subjects, ages 55 and older, being evaluated for Alzheimer's
disease and other causes of cognitive impairment to generate a
tTau/Abeta42 ratio value. As changes in these biomarkers levels
occur at early stages of the disease, the assays can detect
Alzheimer's pathology in earlier stages of disease (e.g., mild
cognitive impairment). Elecsys tTau and Elecsys Abeta42 assays are
both traceable to reference materials, ensuring accuracy of the
tTau/Abeta42 ratio results.7
The ratio of these biomarkers (tTau/Abeta42) is consistent with
a negative amyloid PET scan if the result is less than or equal to
the cutoff (negative), and with a positive amyloid PET scan if the
result is above the ratio cutoff (positive).
Abeta42 and tTau assays are intended to be used in addition to
other clinical diagnostic evaluations to determine whether a person
has Alzheimer's. A positive tTau/Abeta42 ratio result in CSF does
not establish a diagnosis of Alzheimer's disease.
About Roche in Alzheimer's disease
With more than two decades of scientific research in
Alzheimer's, Roche is working toward a day when we can detect the
disease early and stop its progression to preserve what makes
people who they are. Today, the company's Alzheimer's portfolio
spans investigational medicines for different targets, types and
stages of the disease. It also includes approved and
investigational tools, including digital and blood-based tests and
CSF assays, aiming to more effectively detect, diagnose and monitor
the disease. Yet the global challenges of Alzheimer's go well
beyond the capabilities of science, and making a meaningful impact
requires collaboration both within the Alzheimer's community and
outside of healthcare. We will continue to work together with
numerous partners, with the hope we can transform millions of
lives. Learn more about our commitment in the Alzheimer's
space.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial
manufacturers of branded medicines, Roche has grown into the
world's largest biotechnology company and the global leader in
in-vitro diagnostics. The company pursues scientific excellence to
discover and develop medicines and diagnostics for improving and
saving the lives of people around the world. We are a pioneer in
personalized healthcare and want to further transform how
healthcare is delivered to have an even greater impact. To provide
the best care for each person we partner with many stakeholders and
combine our strengths in Diagnostics and Pharma with data insights
from the clinical practice.
In recognizing our endeavor to pursue a long-term perspective in
all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the thirteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
Genentech, in the United
States, is a wholly owned member of the Roche Group. Roche
is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected
by law.
References
[1] van Vliet D, et. al, Time to diagnosis in young-onset
dementia as compared with late-onset dementia. Psychol Med. 2013
Feb;43(2):423-32. doi: 10.1017/S0033291712001122. Epub 2012 May 28.
PMID: 22640548. https://pubmed.ncbi.nlm.nih.gov/22640548/
[2] Sabbagh MN, Lue LF, Fayard D, Shi J. Increasing Precision of
Clinical Diagnosis of Alzheimer's Disease Using a Combined
Algorithm Incorporating Clinical and Novel Biomarker Data. Neurol
Ther. 2017 Jul;6(Suppl 1):83-95. doi:
10.1007/s40120-017-0069-5.
[3] Alzheimer's Association. 2022, December
19. Final and Formal Request for Reconsideration of National
Coverage Determination (NCD) for Monoclonal Antibodies Directed
Against Amyloid for the Treatment of Alzheimer's Disease
(CAG-00460N).
https://alz.org/media/Documents/final-NCD-reconsideration-request.pdf,
page 2, footnote 4.
[4] Cummings, J., Apostolova, L., Rabinovici, G.D., et al.
Lecanemab: Appropriate Use Recommendations. J Prev Alzheimers Dis
(2023).
[5] Elecsys®β–Amyloid (1–42) CSF II assay,
Elecsys® Phospho–Tau (181P) CSF assay and
Elecsys® Total-Tau CSF assay method sheets.
[6] Hampel H, et. al. Designing the next-generation clinical care
pathway for Alzheimer's disease. Nat Aging. 2022 Aug;2(8):692-703.
doi: 10.1038/s43587-022-00269-x. Epub 2022 Aug 19. PMID: 37118137;
PMCID: PMC10148953.
[7] Elecsys®β-Amyloid (1–42) CSF II assay and
Elecsys® Total-Tau CSF assay method sheets.
For Further Information
Roche Diagnostics U.S.
Media Relations
Cindy Zinkovich
+1 (317) 931-8463
cindy.zinkovich@roche.com
us.mediarelations@roche.com
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