Phadia First Company to Receive FDA Clearance of Recombinant Allergen Component Tests
By Phadia, PRNESunday, June 19, 2011
UPPSALA, Sweden, June 20, 2011 -
510(K) Clearance Covers 13 Molecular
Allergen Components
Newly-available tests provide deepest clinical insight into
peanut allergy, as well as allergies to cat dander, dust mite,
Bermuda grass, ragweed, and fungi enabling a significant
improvement in the clinical management of patients with suspected
allergies.
Phadia, the global leader in allergy and autoimmunity diagnostics,
today announced the FDA clearance of recombinant ImmunoCAP allergen
components for marketing in the United States. The FDA clearance
applies to all of Phadia’s instrument platforms.
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Phadia was the first diagnostics company to introduce allergen
component testing globally and the company will continue to lead
and advance the understanding of allergen component testing and its
clinical application. Today’s announcement highlights the
continued leadership role that Phadia plays in the evolution of
innovative allergy diagnostic tools to support improved patient
care. The FDA clearance covers 13 components (9 recombinants
and 4 natives) including peanut, cat, dust mite, Bermuda grass, the
fungi Alternaria alternata and Ragweed. Phadia has a significant
number of additional ImmunoCAP allergen component tests that will
be submitted to FDA this year.
“There is a need for greater understanding of the risk of
clinical reactions. Recent studies suggest that component testing
will help allergy and immunology specialists assess the risk of
clinical reactions. There is much to learn and the allergy and
immunology community is in a perfect position to take the lead in
helping to interpret information gained from allergen component
test results,” says Dr. Hugh A. Sampson, Professor of Pediatrics at
the Mount Sinai School of Medicine and Director of the Jaffe Food
Allergy Institute.
ImmunoCAP specific IgE blood tests are considered the assay of
choice among specialists, and referenced and supported in over
4,000 scientific publications. Today more than 80 components are
available in Europe; ImmunoCAP recombinant allergen components have
been used for over 10 years and native components have been used
for over 30 years.
David Esposito, President and General Manager of Phadia US,
said, “Allergen component testing is the most important new
technology in advancing the care of patients with allergies and
asthma. By identifying the specific molecule within the allergen
causing the allergic reaction, clinicians have more information
than ever to enhance patient care. Allergen component test results
have the potential to assess risk for reaction, explain symptoms
due to cross reactivity and identify a more targeted approach for
patients requiring immunotherapy. This can improve health outcomes,
and provide patient allergy and asthma action plans that make
meaningful improvements in quality of life.”
Phadia has plans to accelerate its ongoing commitment to educate
clinicians and patients on the use of ImmunoCAP allergy testing
platform to support improved patient care. Phadia continues
to reinforce a guidelines-based care approach with its education
efforts and most recently began a significant education effort to
clinicians on the recently released NIH Guidelines for the
Diagnosis and Management of Food Allergy in the US. The NIH
Guidelines highlights the advantages of ImmunoCAP specific IgE
testing compared to other technologies by stating “the predictive
values associated with clinical evidence of allergy for ImmunoCAP
cannot be applied to other test methods.”
About Phadia
Phadia AB is a global leader in allergy, asthma and autoimmunity
diagnostics. Phadia develops, manufactures and markets complete
blood test systems to manage and support clinical diagnosis. Phadia
has marketing companies in more than 20 countries and distributors
in more than 60 countries. For more information please visit
Media Contact:
Ulf Bladin
VP Global Marketing, Corporate Communication, Scientific
Affairs
Tel. +46-18-16-50-00
.
Tags: June 20, Phadia, sweden, Uppsala
