Roche granted FDA Breakthrough Device Designation for blood test to support earlier Alzheimer's disease diagnosis
April 11 2024 - 1:00AM
UK Regulatory
Roche granted FDA Breakthrough Device Designation for blood test to
support earlier Alzheimer's disease diagnosis
- The Elecsys® pTau217 plasma
biomarker test is being developed as part of an ongoing partnership
between Roche and Eli Lilly and Company
- Once approved, the test
will aid healthcare providers in identifying amyloid pathology, a
key feature of Alzheimer’s disease
- Roche and Lilly believe the
test could play an important role in improving access to early and
accurate Alzheimer’s diagnosis
Basel, 11 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that its Elecsys pTau217 assay received
Breakthrough Device Designation from the U.S. Food and Drug
Administration (FDA). This blood test, which is being developed in
collaboration with Eli Lilly and Company, will be used to help
identify the presence or absence of amyloid pathology in
individuals, which can help ensure they are able to receive
appropriate care. This may include participation in clinical trials
or access to approved disease-modifying therapies. If approved, the
test could help rapidly broaden access to a more timely and
accurate diagnosis and potentially mitigate the impact of
Alzheimer’s disease on people and society.
“The incidence of dementia is growing worldwide, with 75 percent
of cases remaining undiagnosed1. Consequently, there is
a critical role for Diagnostics to play in addressing this global
health challenge,” said Matt Sause, CEO of Roche Diagnostics. “We
believe pTau217 is going to be crucial in the diagnosis of
Alzheimer’s disease, a condition where Roche Diagnostics is
committed to improving the lives of patients worldwide. We plan to
leverage our installed base of diagnostic systems, which is the
largest in the world, to ensure we are able to create access to
this test for those who need it the most.”
“The development of the Elecsys pTau217 plasma assay is another
milestone in our collaboration with Roche Diagnostics that will
advance the Alzheimer’s diagnostic ecosystem,” said Anne White,
executive vice president of Eli Lilly and Company, and president of
Lilly Neuroscience. “We’re excited to help meet the growing need
for additional diagnostic tools to enable a timely and accurate
diagnosis for people with Alzheimer’s disease.”
pTau217, which is a phosphorylated fragment of the protein tau,
is a biomarker that has shown the ability in research settings to
distinguish Alzheimer’s disease from other neurodegenerative
disorders and has shown strong performance relative to other
biomarkers2.
As global leaders in Alzheimer’s innovation, Roche and Lilly
hope that this collaboration can bring additional speed and scale
to testing and diagnosis in this important area of unmet medical
need.
About Elecsys pTau217
Elecsys Phospho-Tau (217P) is intended to be an in-vitro diagnostic
immunoassay for the quantitative determination of the protein
Phospho-Tau (217P) (pTau217) in human plasma from individuals aged
60 years and older. The test is intended for use as an aid in
identifying amyloid pathology, a pathological feature of
Alzheimer’s disease.
A positive Elecsys pTau217 result indicates a high likelihood of
having a positive amyloid PET/CSF result.
A negative Elecsys pTau217 result indicates a high likelihood of
having a negative amyloid PET/ CSF result.
An indeterminate pTau217 result indicates uncertainty on the
amyloid PET/CSF result.
The pTau217 result should be used in the diagnostic pathway in
conjunction with other clinical information.
About Roche in Alzheimer’s disease
With more than two decades of scientific research in Alzheimer’s,
Roche is working toward a day when we can detect the disease early
and stop its progression to preserve what makes people who they
are. Today, the company’s Alzheimer’s portfolio spans
investigational medicines for different targets, types and stages
of the disease. This includes trontinemab, an innovative
Brainshuttle™ anti-amyloid treatment that is specifically
engineered to cross the blood-brain barrier. On the diagnostics
side, it also includes approved and investigational tools,
including digital and blood-based tests and cerebrospinal fluid
(CSF) assays, aiming to more effectively detect, diagnose and
monitor the disease. Yet the global challenges of Alzheimer’s go
well beyond the capabilities of science, and making a meaningful
impact requires collaboration both within the Alzheimer’s community
and outside of healthcare. We will continue to work together with
numerous partners with the hope we can transform millions of
lives.
About Breakthrough Device Designation
The 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 endeavour 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 fifteenth 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] Alzheimer’s Disease International [Internet; cited 2024, March
24] Available from:
https://www.alzint.org/news-events/news/over-41-million-cases-of-dementia-go-undiagnosed-across-the-globe-world-alzheimer-report-reveals/
[2] Janelidze et al. Nat Med. 2020;26(3):379-386; Karikari et al.
Lancet Neurol. 2020;19(5):422-433; Palmqvist et al. JAMA.
2020;324(8):772-781; Thijssen et al. Lancet Neurol.
2021;20(9):739-752; Mattsson-Carlgren et al. JAMA Neurol.
2023;80(4):360-369
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