Quanterix Presents Data Demonstrating Successful Multi-Marker Approach for Alzheimer’s Disease Detection that is More Effective than Standalone Plasma p-Tau 217
July 29 2024 - 8:00AM
Business Wire
Quanterix improves on its best-in-class p-Tau 217 standalone
test with new multi-marker approach reducing the number of patients
receiving uncertain results
Quanterix Corporation (NASDAQ: QTRX), a company fueling
scientific discovery through ultrasensitive biomarker detection,
today presented new data at the Alzheimer’s Association
International Conference (AAIC), supporting a novel multi-marker
approach to test for Alzheimer’s disease (AD). For the first time,
new data show that applying a combination of AD-relevant biomarkers
with p-Tau 217 significantly reduces the intermediate zone of a
two-cutoff p-Tau 217 test, while preserving high accuracy above
90%.
Recent Alzheimer’s Association criteria for diagnosing
Alzheimer’s recommends that plasma p-Tau 217 tests be designed with
two cutoffs to confidently differentiate between patients with or
without AD pathology. This two-cutoff approach maximizes the
accuracy of a p-Tau 217 test but leaves a zone of intermediate risk
between the two cutoffs representing inconclusive borderline
amyloid status. It is desirable to reduce this intermediate region
while preserving a test’s accuracy to reduce the number of patients
receiving inconclusive results.
Quanterix investigated whether interrogating intermediate
samples with a panel of additional Alzheimer’s-associated plasma
biomarkers, including combinations of amyloid β 42, amyloid β 40,
GFAP, and NfL, together with p-Tau 217 in an algorithm that
provides a single risk score, would improve the amyloid
classification of uncertain results compared to a stand-alone p-Tau
217 test. The research found that this multi-marker approach
enabled accurate amyloid classifications for 151 of 228 previously
uncertain results across a large, high-diversity cohort of
symptomatic individuals, reducing the intermediate zone 3-fold from
31.2% to 10.5% compared to p-Tau 217 alone. This finding highlights
a potential key benefit of a multi-marker approach to blood-based
Alzheimer’s testing, which is to provide diagnostic certainty for a
significantly greater number of patients undergoing evaluation for
AD.
“Quanterix’s Simoa technology is an exceptionally sensitive
platform, which when combined with our digital p-Tau 217 assay, has
provided a result for all samples tested,” said Masoud Toloue, CEO
of Quanterix. “In over 2,000 samples tested, our LucentAD p-Tau 217
assay has yet to encounter a single result that is unreadable and
combines this sensitivity with an overall accuracy above 90%. With
these novel multi-marker results, we are leveraging the best of our
p-Tau 217 test along with other AD-relevant biomarkers. We believe
that a multi-marker approach is the next phase in the evolution of
blood-based testing, not only for identifying and staging
Alzheimer’s pathology, but also for informing important
differential treatment pathways that include non-Alzheimer’s
neurodegenerative diseases. The latter is an important
consideration given approximately 30% of Alzheimer’s patients have
pathologies other than AD.”
Quanterix is currently investing in further studies to evaluate
multi-marker testing and expects to launch a multi-marker
laboratory developed test later this year through its LucentAD
product line. LucentAD consists of a menu of laboratory developed
tests run under CLIA and focused on applications supporting
Alzheimer’s diagnosis and treatment.
This work is being presented in a virtual poster entitled,
“Multi-Marker Approach to Reducing the Intermediate Range of a High
Accuracy 2-Cutoff Plasma p-Tau 217 Test for Amyloid Detection,”
poster 95706, throughout AAIC. Quanterix will be at AAIC (7/28 –
8/1) at booth #730. Interested parties can schedule time to meet
with Quanterix team members onsite using the event website:
(https://www.quanterix.com/conferences/alzheimers-association-international-conference-aaic-2024/).
To learn more about Lucent Diagnostics, visit:
https://www.lucentdiagnostics.com/.
For more information about Quanterix’s work in neurology, visit:
https://www.quanterix.com/therapeutic-areas/neurology/.
About Quanterix From discovery to diagnostics,
Quanterix’s ultrasensitive biomarker detection is fueling
breakthroughs only made possible through its unparalleled
sensitivity and flexibility. The Company’s Simoa® technology has
delivered the gold standard for earlier biomarker detection in
blood, serum or plasma, with the ability to quantify proteins that
are far lower than the Limit of Quantification (LoQ) of
conventional analog methods. Its industry-leading precision
instruments, digital immunoassay technology and CLIA-certified
Accelerator laboratory have supported research that advances
disease understanding and management in neurology, oncology,
immunology, cardiology and infectious disease. Quanterix has been a
trusted partner of the scientific community for nearly two decades,
powering research published in more than 2,900 peer-reviewed
journals. Find additional information about the Billerica,
Massachusetts-based company at https://www.quanterix.com or follow
us on Twitter and LinkedIn.
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version on businesswire.com: https://www.businesswire.com/news/home/20240729813152/en/
Media: PAN Communications Maya Nimnicht (510) 334-6273
quanterix@pancomm.com
Investor Relations: Francis Pruell, Quanterix (508)
789-1725 ir@quanterix.com
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