Quanterix Launches LucentAD Biomarker Blood Test to Aid Physician Diagnosis of Alzheimer’s Disease in Patients
July 06 2023 - 5:37PM
Business Wire
Test will play an important role in the
evaluation of patients experiencing cognitive symptoms consistent
with early signs of Alzheimer’s disease
Quanterix Corporation (NASDAQ: QTRX), a company fueling
scientific discovery and breakthrough diagnostics through
ultrasensitive biomarker detection, today announced it has launched
LucentAD, a test to assist in the evaluation of patients
experiencing cognitive symptoms consistent with the early signs of
Alzheimer’s disease (AD). The LucentAD test, which will be
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. This information will help
healthcare providers determine appropriate follow up and treatment
planning for a suspected Alzheimer’s patient.
The LucentAD test is run by Quanterix’s CLIA laboratory, which
powers many of the clinical trials associated with AD. Lucent
Diagnostics is Quanterix’s new healthcare provider-facing portal,
launched to meet the needs of patients at the same time a therapy
for the disease has become more widely available. The test measures
an isoform of phosphorylated tau protein in plasma. This isoform is
phosphorylated at the 181 residue of the protein (p-Tau 181), and
its concentration in plasma and cerebrospinal fluid, has been
positively correlated to the presence of amyloid pathology in the
brain, a hallmark of Alzheimer’s disease. LucentAD utilizes the
Simoa p-Tau 181 assay that has been extensively studied in large
longitudinal and cross-sectional cohorts, and its high specificity
for amyloid pathology for AD has been well established through
comparison to amyloid positron emission tomography, a gold standard
for AD diagnosis. p-Tau 181 is a low-abundance protein in blood,
requiring high analytical sensitivity for its reliable measurement.
While the clinical validity of Simoa plasma p-Tau 181 measurements
have been well studied, the test has also recently been shown to
correlate with reduction in amyloid load in the brains of amyloid
patients on anti-amyloid drug therapy, as demonstrated in the
lecanemab (Leqembi) Clarity AD drug trial.
“A year ago, Quanterix announced the validation of our
laboratory developed test to quantitatively measure p-Tau 181 in
plasma as an aid in diagnostic evaluation of Alzheimer’s disease,”
said Masoud Toloue, CEO at Quanterix. “The launch of Lucent
Diagnostics and availability of the LucentAD test expands access to
our p-Tau 181 test for healthcare providers and marks an important
step in our goal to help build a global Alzheimer’s disease testing
infrastructure.”
The announcement of the LucentAD test comes at an exciting time
for AD treatment and discovery, coupled with today’s historic
announcement FDA approval of Leqembi, the first disease-modifying
drug for Alzheimer’s to receive full approval. Earlier this year,
Leqembi was granted accelerated approval by the FDA for the
treatment of patients with early-stage AD, an important step
forward in the fight against the disease, based on strong early
clinical trial data. As detailed in the Leqembi labeling for
accelerated approval, several biomarkers were used to track
response to therapy, including plasma p-Tau 181, which was measured
using Quanterix’s Simoa® platform.
“The FDA’s approval of Leqembi is an exciting day for families
of the 55 million Alzheimer’s patients globally,” continued Toloue.
“However, access to therapy will continue to be limited until the
global infrastructure for patient testing is built. Non-invasive
blood biomarker testing is the only way to democratize access to
Alzheimer’s disease therapies and Quanterix will offer our testing
solutions to healthcare providers who want to provide this
important service to patients.”
“The clinicians working with dementia patients are viewing the
coming of FDA-approved therapies for Alzheimer’s disease with a
mixture of excitement and anxiety, as the diagnostic paths to
qualify patients for treatment in clinical practice are still
inefficient in most clinics,” said Tharick Pascoal, MD., Ph.D.
Behavior Neurologist and Associate Professor of Psychiatry and
Neurology at the University of Pittsburgh. “The availability of
non-invasive blood tests to more efficiently identify patients for
these treatments is an urgent need at a critical moment in the
fight against this disease.”
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
181. Circulating levels of p-Tau 181 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 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/20230706742971/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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