FDA Approves Dako A/S HER2 CISH pharmDx(TM) Kit

GLOSTRUP, DENMARK--(Marketwire - December 14, 2011) -

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™ 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™ 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™ 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™ 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™ 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™ 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™ 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™ Kit, test slides can be stored for re-evaluation.

"I am happy to announce the FDA approval of HER2 CISH pharmDx™ Kit. We have seen how other Dako HER2 pharmDx™ products have helped many women with breast cancer by determining the right treatment for their disease. This latest addition to our pharmDx™ 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™ 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™ 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™ Kit HER2 CISH pharmDx™ 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™ 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.

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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