Quanterix Launches High Accuracy p-Tau 217 Blood Biomarker Test to Aid Physician Diagnosis of Alzheimer’s Disease
October 24 2023 - 4:30PM
Business Wire
New test elevates the performance standard for blood biomarker
tests intended for detecting amyloid pathology in individuals with
cognitive impairment
Lucent Diagnostics, a diagnostics brand of Quanterix Corporation
(NASDAQ: QTRX), today announced expansion of its LucentAD product
line with the addition of a high accuracy p-Tau 217 blood test for
Alzheimer’s disease – LucentAD p-Tau 217. This lab developed test
marks a major advance in the performance of scalable
immunoassay-based blood biomarker tests intended for assessing
amyloid pathology in individuals with memory complaints.
p-Tau 217 has emerged as a top performing biomarker for
Alzheimer’s pathology, enabling clinical sensitivity and
specificity in blood. Traditional methods include positron emission
tomography (PET) or lumbar puncture for cerebrospinal fluid (CSF)
biomarkers, which are expensive, invasive, and lack wide
availability. The recent approval of new therapies has highlighted
an urgent need for improved diagnostic methods. Highly sensitive
and specific blood-based biomarker tests have the potential to
speed diagnosis and expand access to treatments for millions of
individuals with early Alzheimer’s disease.
LucentAD p-Tau 217 leverages the combination of Quanterix’s
ultra-sensitive Simoa® technology and J&J
Innovative Medicine’s extensively studied p-Tau 217 antibodies to
provide high accuracy with a simplified workflow. Samples can be
shipped unfrozen to the Lucent laboratory in packaging provided by
Lucent, streamlining the testing process for providers. Training
and clinical validation were performed in a combined cohort of over
500 subjects with a range of cognitive status, including subjective
cognitive decline, mild cognitive impairment, and early AD. The
validation compared the test output to amyloid status determined by
CSF biomarker testing. The LucentAD p-Tau 217 test achieved an
overall accuracy exceeding 90%, which meets the stringent
requirements set forth in the most recent NIA-AA Revised Criteria
for Diagnosis and Staging of Alzheimer's Disease. Furthermore, the
NIA-AA criteria identify p-Tau 217 as the only plasma biomarker
appropriate for accurately diagnosing amyloid pathology.
“The LucentAD p-Tau 217 test provides industry leading
performance combined with a simplified workflow for the provider,”
said Masoud Toloue, CEO of Quanterix. “The launch of LucentAD p-Tau
217 is an important milestone in our efforts to build broad-based
non-invasive testing for amyloid pathology. We believe that Simoa
technology offers the world's only full range scalable clinical
solution, overcoming the complexities and limitations of less
sensitive single-plexed analog immunoassay platforms that struggle
to measure this important biomarker. We will make this test
available worldwide to all, in our pursuit of improving access to
life changing diagnostics and treatments for the millions of
individuals and their families living with Alzheimer’s
disease.”
“LucentAD p-Tau 217 has the potential to dramatically change the
clinical workflow for diagnosing and treating Alzheimer’s patients.
High accuracy blood biomarker tests can reduce the reliance on PET
and CSF testing availability and simplify the process of
determining the presence of AD pathophysiology,” said Tharick
Pascoal MD, PhD (neurologist and Associate Professor of Neurology
and Psychiatry at the University of Pittsburgh School of Medicine).
“These advances will provide significant benefits to patients,
providers, and health systems as new therapies become
available.”
The LucentAD product line consists of a menu of laboratory
developed tests run under CLIA and focused on applications
supporting Alzheimer’s diagnosis and treatment. Lucent Diagnostics
will announce additional tests aimed at improving the diagnosis and
management of Alzheimer’s and other neurological disorders. The
LucentAD test is available through a healthcare provider’s
order.
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/.
Disclaimer
The LucentAD test was developed and validated by Quanterix
Corporation (CLIA# 22D1053083) in a manner consistent with CLIA
requirements. The test has not been cleared or approved by the U.S.
Food and Drug Administration.
The Lucent test measures tau protein phosphorylated at threonine
217. Circulating levels of p-Tau 217 have been shown to be a marker
of Alzheimer’s Disease (AD) pathology. The test results are
intended as an aid in the diagnostic evaluation of AD, to be used
in adults presenting with cognitive impairment who are being
evaluated for AD. LucentAD test results must be interpreted in
conjunction with other diagnostic tools. This test is not intended
as a standalone screening or diagnostic assay.
About Lucent Diagnostics
Committed to transforming the landscape of Alzheimer’s Disease
(AD) diagnostic testing, Lucent Diagnostics, a Quanterix brand, is
revolutionizing AD patient care by providing accurate, reliable,
and actionable diagnostic information to healthcare professionals
and patients alike. Lucent Diagnostics harnesses Quanterix’s
ultrasensitive Simoa® technology—the groundbreaking biomarker
detection technology that delivers the gold standard for earlier
biomarker detection in blood, serum or plasma— to power its mission
of addressing the critical need for advanced diagnostic tools that
can measure biomarkers associated with neurodegenerative diseases.
The LucentAD test, powered by Simoa®, is available to healthcare
providers as an aid in conjunction with other diagnostic tools,
provides clinicians with a simplified process to quickly assess the
likelihood of a patient having amyloid pathology consistent with
AD, allowing for early or preventative AD treatment. The LucentAD
product line currently measures p-Tau 181 and p-Tau 217 in plasma,
two of the top performing biomarkers for AD. Find additional
information about the Billerica, Massachusetts-based company at
https://www.lucentdiagnostics.com/ or follow us on Twitter and
LinkedIn.
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
2,000 peer-reviewed journals. Find additional information about the
Billerica, Massachusetts-based company at https://www.quanterix.com
or follow us on Twitter and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,”
“estimate,” “intend” and similar expressions (as well as other
words or expressions referencing future events, conditions or
circumstances) are intended to identify forward-looking statements.
Forward-looking statements in this news release are based on
Quanterix’s expectations and assumptions as of the date of this
press release. Each of these forward-looking statements involves
risks and uncertainties. Factors that may cause Quanterix’s actual
results to differ from those expressed or implied in the
forward-looking statements in this press release are discussed in
Quanterix’s filings with the U.S. Securities and Exchange
Commission, including the “Risk Factors” sections contained
therein. Except as required by law, Quanterix assumes no obligation
to update any forward-looking statements contained herein to
reflect any change in expectations, even as new information becomes
available.
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version on businesswire.com: https://www.businesswire.com/news/home/20231024523870/en/
Media: Maya Nimnicht, PAN Communications (510) 334-6273
pan.quanterix@pancomm.com Investor Relations: Ed Joyce, Quanterix
(610) 306-9917 ir@quanterix.com
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