FDA approves Dako HER2 CISH pharmDx(TM) Kit
(Thomson Reuters ONE) -
Dako, a world leader in tissue-based cancer diagnostics, has received approval
from the US Food and Drug Administration (FDA) to market HER2 CISH pharmDx(TM)
Kit in the United States. This new diagnostic test is specifically developed as
an aid in the assessment of breast cancer patients for whom treatment with
Herceptin® is being considered. It allows pathologists to perform validated FISH
tests and score the results using readily available bright field microscopes.
HER2 CISH pharmDx(TM) Kit from Dako opens the way to molecular testing in breast
cancer diagnosis for a wider group of pathology laboratories, offering a number
of benefits to the pathologists.
"With the FDA approval of HER2 CISH pharmDx(TM) Kit, Dako has provided another
important tool to aid in the selection of therapy for patients diagnosed with
breast cancer. The approval of HER2 CISH pharmDx(TM) Kit provides a welcome
methodology for the evaluation of HER2 status in breast cancer that eliminates
the need for fluorescence microscopy. A clear advantage of HER2 CISH pharmDx(TM)
Kit is that the stains are permanent and can be archived for later examination,"
says David Hicks, M.D., Director of Surgical Pathology, University of Rochester
Medical Center, New York.
Traditionally, molecular testing requires the use of a fluorescence microscope
which is not readily available in all pathology laboratories. With HER2 CISH
pharmDx(TM) Kit, however, the pathologist can use a traditional bright field
microscope to determine whether the patient is eligible for treatment with
Herceptin®.
HER2 CISH pharmDx(TM) Kit is a dual color test that is generally preferred
compared to single color tests, as both the HER2 gene and Centromere-17
reference signals can be seen on the same slide. The HER2 scoring, which is
supported by a standardized and validated protocol, is considerably faster with
a CISH test than with a FISH test. Moreover, with HER2 CISH pharmDx(TM) Kit,
test slides can be stored for re-evaluation.
"I am happy to announce the FDA approval of HER2 CISH pharmDx(TM) Kit. We have
seen how other Dako HER2 pharmDx(TM) products have helped many women with breast
cancer by determining the right treatment for their disease. This latest
addition to our pharmDx(TM) portfolio of products supports Dako's mission to
fight cancer by assisting pathologists in generating even more accurate,
objective and reproducible diagnostic results to the benefit of cancer
patients," says Lars Holmkvist, CEO of Dako.
A recent study comprising 365 breast cancer patients showed 98.3 and 97.7
percent concordance between results obtained with HER2 CISH pharmDx(TM) and two
FDA-approved HER2 FISH tests. This is well over the threshold of 95 percent
recommended by the American Society of Clinical Oncology (ASCO) and the College
of American Pathologists (CAP).
HER2 CISH pharmDx(TM) Kit was CE-IVD marked in June 2010. The product has now
received FDA's approval and will be available to US customers as of February
2012.
About HER2 CISH pharmDx(TM) Kit
HER2 CISH pharmDx(TM) Kit is a dual color chromogenic assay designed to
quantitatively determine HER2 gene amplifications in breast cancer tissue
specimens, using a bright field microscope for the HER2 scoring. In a subset of
patients (20-25%) with breast cancer, the HER2 gene is amplified. HER2 CISH
pharmDx(TM) Kit is indicated as an aid in the assessment of patients for whom
Herceptin® treatment is being considered.
Herceptin® was developed to specifically target HER2-positive breast cancers.
Demonstration of high HER2 overexpression or gene amplification is essential for
treatment with Herceptin®. Clinical studies have shown that breast cancer
patients whose tumors have high HER2 receptor overexpression and/or
amplification benefit the most from Herceptin®.
About pharmacodiagnostics testing and personalized medicine
Pharmacodiagnostic testing is performed in order to aid in the selection of
patients for a treatment. This testing is a prerequisite for the implementation
of personalized medicine where identification of the individual's biological
characteristics makes it possible to determine whether the patient will respond
to a specific drug treatment or not.
Media contact
Maia Fredtoft Søchting
Corporate Communications
Dako Denmark A/S
Tel. +45 25 46 10 83
About Dako
Dako, based in Denmark, is a global leader in tissue-based cancer diagnostics.
Hospital and research laboratories worldwide use Dako's know-how, reagents,
instruments and software to make precise diagnoses and determine the most
effective treatment for patients suffering from cancer. Employing more than
1000 people and being present in more than 80 countries, Dako covers essentially
all of the anatomic pathology markets globally. Dako is owned by a private
equity fund EQT.
www.dako.com
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Source: Dako Denmark A/S via Thomson Reuters ONE
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Datum: 14.12.2011 - 16:00 Uhr
Sprache: Deutsch
News-ID 97148
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