The company’s ultra-sensitive biomarker technology supports
milestone achievement in establishing a method for clinicians to
identify and interpret elevated values of sNfL in children and
adolescents
Quanterix Corporation (NASDAQ: QTRX), a company fueling
scientific discovery and breakthrough diagnostics through
ultrasensitive biomarker detection, today announced that its Simoa®
technology supported a large international study to establish sNfL
reference ranges to assess neurological disease activity in
children and adolescents, according to a recent study published in
The Lancet Neurology. Researchers from the University Hospital
Basel and University of Basel, led by Professor Jens Kuhle,
leveraged Simoa’s ability to precisely detect the sNfL protein at
ultra-low levels, enabling a large-scale international study in
which sNfL could be reliably measured across a spectrum of healthy
persons ranging in age from neonatal to adolescence.
The Blood Neurofilament Light Chain (NfL) is an innovative
biomarker that specifically indicates neuroaxonal health. However,
its clinical application has been constrained due to the lack of
established reference ranges for children and adolescents. Accurate
monitoring of neuroaxonal injury in neurologic and systemic
diseases is of pivotal importance at population and individual
patient levels. In the pediatric population, tools capturing
neuroaxonal injury with high specificity would substantially
facilitate early and accurate detection of conditions associated
with short- and long-term neurological disabilities with
considerable socioeconomic impact. This may also accelerate
clinical trials evaluating the expanding library of targeted causal
and disease-modifying treatments.
“By utilizing Simoa’s ultra-sensitive technology, our research
team has been able to reach this milestone achievement for two
major cohorts of children and adolescents in Europe and North
America,” said Jens Kuhle, Professor and Head of the
Neuroimmunology Unit and Multiple Sclerosis Center at the
University Hospital Basel. “Measurement of serum NfL concentrations
has the potential to substantially contribute to counseling of
children and their parents and adolescents with neurological
conditions, representing a significant driver of pediatric
disability concerns worldwide. The European Medicines Agency has
recently called introducing age-adjusted reference values for NfL a
top research priority in this context.”
The study, “Serum neurofilament light chain reference database
for individual application in pediatric care,” is the most
comprehensive study within this population to date, examining 2,667
samples from donors spanning different ages, an important factor
known to affect sNfL values. Persons with neurological conditions
were excluded from the reference range cohorts. Because of the
diverse patient set, this study helped establish a statistically
robust reference database, which can be used in conjunction with a
new internet-based method to support clinicians when interpreting
results of sNfL levels in individual children and adolescents aged
18 years old or younger. Establishing normative values for sNfL for
pediatric cases provides a vital advance to overcome some of the
existing constraints, paving the way for the clinical application
of blood NfL in this population.
“sNfL measurements represent an important opportunity to advance
the care of children with neurological conditions,” said Masoud
Toloue, CEO at Quanterix. “Age-adjusted reference ranges for
children expands the utility of blood NfL measurements to this
population group and enables physicians to interpret what is
‘normal’ and ‘abnormal’ NfL in a quantitative and individual way in
this age group for the first time. A particular advantage of the
high sensitivity of the digital Simoa NfL assay is the ability to
precisely measure NfL from small sample volumes, such as heel
sticks from neonatal children, or even from dried blood spots. This
allows a single platform to be used for all types of patients and
sample types.”
“With the recent addition of NfL to our expanding menu of
CLIA-validated lab developed tests, we are aiming our
ground-breaking Simoa technology at neurological diseases across a
large spectrum of patients, including children. For example, recent
data suggest sNfL may be a suitable biomarker for disease activity
in children with spinal muscular atrophy in the initial stages of
the disease during early childhood. The clinical potential and
impact of blood NfL continues to expand, both as a single assay and
in combination with other biomarkers, and we look forward to
further growing our menu of clinically validated Simoa assays
toward improving clinical care,” continued Toloue.
To learn more about Quanterix’s Simoa® technology, visit:
https://www.quanterix.com/simoa-technology/.
For more information about Quanterix’s work in neurology, visit:
https://www.quanterix.com/therapeutic-areas/neurology/.
The Study
Led by Jens Kuhle at the University Hospital of Basel and Sven
Wellmann at the University Hospital of Regensburg, an international
team comprising top-tier institutes from Switzerland, Germany, and
the United States conducted comprehensive analyses of NfL
concentrations in more than 2,500 healthy children and adolescents.
This important study has been published in The Lancet
Neurology.
The study authored by A Abdelhak, F Petermeier and P Benkert et
al., provides essential insights for the correct interpretation of
NfL concentrations in the pediatric population, emphasizing its
unique, age-related dynamics. These findings are particularly
distinct from previous descriptions by the same group for the adult
population.
This landmark research significantly enhances the precision of
pediatric health assessments and diagnoses, thereby contributing to
the evolution of global children's healthcare. The established
reference dataset provides healthcare providers with a definitive
standard for comparison, enabling more accurate interpretation of
NfL levels in children's blood tests.
In turn, this facilitates more precise diagnoses, optimizes
monitoring of disease progression, and enables a more
individualized approach to treatment. With this key reference
range, the ability to understand and monitor children's neuroaxonal
health is significantly enhanced.
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/20230731189843/en/
Study Media Contact: Prof. Dr. med. Dr. phil. Jens Kuhle Head
Multiple Sclerosis Centre and Neuroimmunology Unit Neurology
Departments of Head, Spine and Neuromedicine, Biomedicine and
Clinical Research Jens.kuhle@usb.ch
Quanterix Media Contact: Maya Nimnicht, PAN Communications (510)
334-6273 pan.quanterix@pancomm.com
Investor Relations Contact: Ed Joyce, Quanterix (610) 306-9917
ejoyce@quanterix.com
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