The Global CEO Initiative on Alzheimer’s Disease Publishes the First Performance Recommendations for Blood-Based Biomarker Tests by Experts in the Field
12 Junio 2024 - 8:10AM
The Global CEO Initiative on Alzheimer’s Disease (CEOi), convened
by UsAgainstAlzheimer’s, is proud to announce the peer-reviewed
publication of their latest manuscript by their Blood-Based
Biomarker (BBM) Workgroup, “The Global CEO Initiative on
Alzheimer’s Disease performance recommendations for blood-based
biomarker tests” in the journal Nature Reviews Neurology.
“Blood tests for Alzheimer’s disease promise to provide an
earlier and more accurate diagnosis for many patients with
cognitive impairment. However, some currently available blood
tests are extremely accurate while others are little better than
flipping a coin. We worked with many different stakeholders
to develop minimum standards for the accuracy of these blood tests,
because we know that a timely and accurate diagnosis of Alzheimer’s
disease has a major impact on a patient’s life,” said Dr. Suzanne
Schindler, Department of Neurology, Washington University School of
Medicine and BBM Workgroup Co-Lead.
The widespread adoption of amyloid positron emission tomography
(PET) and cerebrospinal fluid (CSF) biomarkers has been hindered by
cost, accessibility barriers in clinical care settings, and a lack
of general guidelines for evaluation. However, as advancements in
disease-modifying treatments for early symptomatic Alzheimer’s
disease continue to emerge, there is an urgent need for earlier and
more accessible diagnostic methods, including biomarker
testing.
CEOi convened a BBM Workgroup of 90 stakeholders from
healthcare, academia, non-profit, government, venture capital,
industry, and patient advocacy to establish minimum acceptable
performance standards for BBM tests in clinical practice. These
standards reflect an expert consensus, marking the first-time
stakeholders have united to establish a common framework.
“Expert consensus on the performance and use of new diagnostic
tools was critical to spur transforming care for conditions like
cancer and heart disease. With the publication of these
recommendations, we are excited that patients and their families
will have more timely and equitable access to new, innovative
Alzheimer’s therapeutics,” said George Vradenburg, convener of
CEOi.
The performance standards published today
outline how BBM tests can be used either as confirming the presence
of disease pathology without further amyloid PET or CSF testing or
as a triaging test where follow-up imaging or CSF is needed.
For confirmation of pathology, the workgroup recommends BBM tests
show performance equivalent to CSF tests for confirmation. While
for the triaging process the workgroup recommends >85
specificity in primary care and > 75 in secondary care depending
upon availability of follow-up testing.
By adhering to these performance standards, high-quality BBM
tests have the potential to revolutionize Alzheimer's diagnosis,
enabling more patients to receive the timely and accurate
assessment of whether they may wish to consider using newly
approved disease-modifying treatments.
For more information, please visit the CEOi BBM website.
About CEOi: The Global CEO Initiative on Alzheimer’s Disease
(CEOi), convened by UsAgainstAlzheimer’s in 2013, is an
organization of global private-sector leaders from across the
pharmaceutical, biotech, diagnostics, caregiving and financial
sectors, who have joined together to provide business leadership in
the fight against Alzheimer’s. CEOi partners with leaders from all
sectors to transform the disease from a social, health, and
economic crisis into an opportunity for healthy aging
worldwide.
Media requests should be directed to: Caroline Hubbard, CEOi
Secretariat chubbard@highlanterngroup.com.
Caroline Hubbard
The Global CEO Initiative on Alzheimer's Disease
415-860-6565
chubbard@highlanterngroup.com