Published Scientific Study Proves Efficacy of Eurofins Viracor-IBT’s ImmuKnow® Test, Improving Patient Survival Rate
June 11 2015 - 2:00AM
Business Wire
Regulatory News:
Eurofins Scientific (Paris:ERF) (EUFI.PA), the global
leader in bio-analytical testing, and one of the world leaders in
genomic services, is pleased to present the results from a recent
study1 published in Transplantation2, showing that Viracor-IBT’s
ImmuKnow, the FDA-cleared immune cell function assay that detects
cell-mediated immunity in immunosuppressed patients, helps improve
outcomes in solid organ transplant (SOT) patients. The study
demonstrated that the ImmuKnow assay provided additional data which
helped optimize immunosuppression, and ultimately improve patient
survival rate3.
In solid organ transplantation, optimizing a patient’s
immunosuppressive therapy is critical in balancing the risk of
organ rejection caused by an inadequately suppressed immune system,
and the risk of infection, cancer and drug toxicity caused by
over-immunosuppression. Results from the study show the ImmuKnow
assay provides a useful biomarker which enables optimizing
immunosuppression to improve patient outcomes by preventing
bacterial and fungal infections, reducing immunosuppressant drug
use and improving 1-year patient survival. The use of the ImmuKnow
assay in a hospital’s immunosuppression protocol can therefore
increase the success rate in organ transplantation.
Specifically, the study showed that the use of the ImmuKnow
assay helped (1) increase patient survival by 13% one year
post-transplant (2) decrease infections over 2 weeks
post-transplant; and (3) lower immunosuppressant drug dosage
(tacrolimus). While there have been numerous retrospective and
prospective studies over the years demonstrating the ability of
ImmuKnow in identifying patients at risk of organ rejection and
infection, this is the first interventional, outcomes-based study,
which generated much discussion at the American Transplant Congress
(ATC) in May 2015.
Comment from Gilles Martin, Eurofins Scientific CEO: “The
ImmuKnow assay is just one of the specialized tests with fast
turnaround time that Viracor-IBT, part of the Eurofins Scientific
Group, offers to aid in the diagnosis and differentiation of SOT
complications. The findings of this study, particularly the
improvement in 1-year patient survival among transplant patients,
are encouraging, and illustrate the positive impact that Eurofins
aspires to across the Group. In line with its commitment to
contribute positively to health, Eurofins promotes innovation
across its laboratory network to develop technologies and
analytical methods that take scientific advancements to benefit
patients and consumers.”
“Immunosuppression Modifications Based on an Immune Response
Assay: Results of a Randomized, Controlled Trial”. Transplantation.
March 9, 2015. Summary of findings:
The prospective, randomized, controlled, blinded, interventional
study involved 202 adult liver transplant recipients. Patients were
divided into two groups; 102 patients received standard
immunosuppressive therapy (control group) and 100 patients received
adjustments to therapy based on their cell-mediated immune
responses determined by the ImmuKnow assay (interventional group).
In the interventional group, patients were tested with the ImmuKnow
assay before liver transplantation, immediately after surgery and
at each clinic visit occurring at approximately day 1, weeks 1 to
4, 6 and 8 and months 3 to 6, 9 and 12. The assay was repeated
within 7 days of a suspected or confirmed rejection or infection,
and again within one week after resolution of the event.
Based on immune function values, tacrolimus doses were reduced
25% when values were less than 130 (low immune cell response) and
increased 25% when values were greater than 450 (strong immune cell
response). This means that physicians are able to adjust the amount
of the immunosuppressant drug, tacrolimus, to a more optimal,
patient-specific level, helping maintain the critical balance
between reducing organ rejection and patient infections. The study
concludes that ImmuKnow provides a useful biomarker which enables
optimizing immunosuppression to improve patient outcomes by
preventing bacterial and fungal infections, reducing
immunosuppressant drug use and improving 1-year patient
survival.
ImmuKnow® is FDA cleared for the following intended use:
Detection of cell-mediated immune response in populations
undergoing immunosuppressive therapy for organ transplant.
For more information please visit
http://www.eurofins.com
Notes for the editor:
Eurofins – a global leader in bio-analysis
Eurofins Scientific is the world leader in food and
pharmaceutical products testing. It is also number one in the world
in the field of environmental laboratory services and one of the
global market leaders in agroscience, genomics, discovery
pharmacology and central laboratory services.
With over 17,000 staff in more than 200 laboratories across 36
countries, Eurofins offers a portfolio of over 130,000 reliable
analytical methods for evaluating the safety, identity,
composition, authenticity, origin and purity of biological
substances and products. The Group provides its customers with
high-quality services, accurate results in time and expert advice
by its highly qualified staff.
Eurofins is committed to pursuing its dynamic growth strategy by
expanding both its technology portfolio and its geographic reach.
Through R&D and acquisitions, the Group draws on the latest
developments in the field of biotechnology and analytical chemistry
to offer its clients unique analytical solutions and the most
comprehensive range of testing methods.
As one of the most innovative and quality oriented international
players in its industry, Eurofins is ideally positioned to support
its clients’ increasingly stringent quality and safety standards
and the expanding demands of regulatory authorities around the
world.
The shares of Eurofins Scientific are listed on the Euronext
Paris Stock Exchange (ISIN FR0000038259, Reuters EUFI.PA, Bloomberg
ERF FP).
Important disclaimer:
This press release contains forward-looking statements and
estimates that involve risks and uncertainties. The forward-looking
statements and estimates contained herein represent the judgement
of Eurofins Scientific’ management as of the date of this release.
These forward-looking statements are not guarantees for future
performance, and the forward-looking events discussed in this
release may not occur. Eurofins Scientific disclaims any intent or
obligation to update any of these forward-looking statements and
estimates. All statements and estimates are made based on the data
available to the Company as of the date of publication, but no
guarantee can be made as to their validity.
1 Ravaioli M, Neri F, et al. Immunosuppression Modifications
Based on an Immune Response Assay: Results of a Randomized,
Controlled Trial. Transplantation. Epub* March 9, 2015.2 The
official Journal of The Transplantation Society, published
monthly.3 Refer to Summary of the findings of the study on p.2 of
this press release
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version on businesswire.com: http://www.businesswire.com/news/home/20150611005395/en/
Viracor-IBTJenni Miller, +1-800-305-5198Corporate
Communicationsjenni.miller@viracoribt.comorEurofins
ScientificInvestor Relations, +32 2 766 1620E-mail:
ir@eurofins.com
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