Roche’s Elecsys NfL test, an important aid for those living with Multiple Sclerosis, is granted FDA Breakthrough Device Designation
November 09 2023 - 1:00AM
Roche’s Elecsys NfL test, an important aid for those living with
Multiple Sclerosis, is granted FDA Breakthrough Device Designation
- Roche Elecsys NfL aids in
detection of disease activity in adults with Multiple Sclerosis
supporting better disease management decisions
- Elecsys NfL offers a
minimally invasive testing option that can provide rapid answers to
patients and caregivers
- NfL has the potential to
provide patient insights for other neurological conditions such as
Alzheimer’s and Huntington’s diseases
Basel, 9 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that its Elecsys® Neurofilament Light Chain (NfL)
test for Multiple Sclerosis (MS) received Breakthrough Device
Designation from the U.S. Food and Drug Administration (FDA). The
Elecsys NfL test is intended to be used as an aid in detection of
disease activity in adults (18-55 years old) with
Relapsing-Remitting Multiple Sclerosis (RRMS) or Secondary
Progressive Multiple Sclerosis (SPMS), providing critical insights
for disease management.
“Around 2.8 million people are estimated to live with Multiple
Sclerosis1. After diagnosis, many face challenges with managing
their disease due to significant gaps in access to testing. This
can lead to missed opportunities to detect disease progression in
support of treatment optimisation,” said Matt Sause, CEO of Roche
Diagnostics. “We are excited about the potential Elecsys NfL has to
improve outcomes for MS patients by offering a minimally invasive
blood draw that can deliver rapid results.”
Approximately 85% of MS cases are RRMS patients.2 The majority
of people diagnosed with RRMS eventually transition to SPMS, in
which neurologic function worsens over time and disability
increases. For patients with RRMS and SPMS, detection of disease
activity is critically important in enabling them and their
physicians to make the best possible decisions for the management
of the disease.
Although the current spotlight for NfL’s intended use is
Multiple Sclerosis, increases in NfL concentrations have been
reported in individuals with other neurodegenerative diseases, such
as Alzheimer’s and Huntington’s diseases and in indications beyond
neurology.
Elecsys NfL has the potential to help laboratories to scale MS
testing on widely available, fully automated and standardised Roche
cobas instruments with the confidence of IVD quality, in a timely
manner.
In July 2022, the FDA also granted Breakthrough Device
Designation to Roche’s Elecsys Amyloid Plasma Panel, an innovative
new solution to enable Alzheimer’s disease to be detected earlier.
With Elecsys NfL receiving this designation, it is an important
step as the organisation strengthens its diagnostics neurology
portfolio to meet growing societal needs.
About Elecsys® NfLNeurofilament Light Chain
(NfL) is an abundant protein exclusively present in neurons and a
sensitive indicator of neuroaxonal damage. Under normal conditions,
NfL is released at low level from axons however, this rate
increases with age and following neuroaxonal damage. Therefore,
abnormal, elevated levels of NfL can be detected in cerebrospinal
fluid and blood in various acute and chronic neurological
disorders. Although the current spotlight for NfL’s intended use is
multiple sclerosis, increases in NfL concentrations have been
reported in individuals with traumatic brain injury, amyotrophic
lateral sclerosis, frontotemporal dementia, Alzheimer’s disease,
Huntington’s disease and other neurodegenerative diseases 3, but
also in other indications beyond neurology.
Roche’s Elecsys NfL is intended to be used as an aid in
detection of disease activity in adults (18-55 years old) with
Relapsing-Remitting Multiple Sclerosis (RRMS) or Secondary
Progressive Multiple Sclerosis (SPMS).
Once approved, broad global access to this testing will exist
through the 75,000 Roche instruments currently available
worldwide.
About the Breakthrough Device DesignationThe
Breakthrough Devices Program is a voluntary program for certain
medical devices that provide for more effective treatment or
diagnosis of a life-threatening or irreversibly debilitating
disease or condition. This program is designed to expedite the
development and review of these medical devices.
About Roche Founded in 1896 in Basel,
Switzerland, as one of the first industrial manufacturers of
branded medicines, Roche has grown into the world’s largest
biotechnology company and the global leader in in-vitro
diagnostics. The company pursues scientific excellence to discover
and develop medicines and diagnostics for improving and saving the
lives of people around the world. We are a pioneer in personalised
healthcare and want to further transform how healthcare is
delivered to have an even greater impact. To provide the best care
for each person we partner with many stakeholders and combine our
strengths in Diagnostics and Pharma with data insights from the
clinical practice.
In recognising our endeavor to pursue a long-term perspective in
all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the thirteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
Genentech, in the United States, is a wholly owned member of the
Roche Group. Roche is the majority shareholder in Chugai
Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected
by law.References[1] Walton C, King R, Rechtman L,
et al. Rising prevalence of multiple sclerosis worldwide: Insights
from the Atlas of MS, third edition. Mult Scler. 2020 Dec; 26
(14):1816-1821[2] MS Society [Internet; cited 2023, Oct 25]
Available from:
https://www.mssociety.org.uk/about-ms/types-of-ms/relapsing-remitting-ms[3]
Mayo Clinic [Internet; cited 2023, Oct 25] Available
from: https://www.mayocliniclabs.com/test-catalog/overview/616854#Clinical-and-Interpretive
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