GLOSTRUP, DENMARK--(Marketwire - November 08, 2010) - Dako, a Danish based world leader in tissue-based cancer diagnostics, today launches a new member of its companion diagnostics product portfolio, the HER2 CISH pharmDx™ Kit, in Europe, Canada and a number of other countries. The 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 gene tests with the use of readily available bright field microscopes.
The new 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 in the laboratories.
"HER2 CISH pharmDx™, with its convenience for bright field technology, is likely to win the wide appeal of pathologists, who are increasingly engaged in diagnostic biomarking of breast cancer," says Bharat Jasani, Professor, Head of Pathology, Department of Medical Genetics, Haematology & Pathology at Cardiff University School of Medicine in the UK.
Traditionally, molecular testing requires the use of a fluorescence microscope which is not readily available in all pathology laboratories. With the HER2 CISH pharmDx™ Kit, however, the pathologist can use a traditional bright field microscope to determine whether the patient is likely to benefit from receiving treatment with Herceptin®.
"Dako CISH staining is very reliable. Whereas FISH requires an expensive fluorescence microscope and a dark room, Dako dual color CISH is now feasible in any diagnostic or pathology laboratory. In my opinion, this technology will immensely benefit molecular testing in pathology laboratories," says J. Han J. M. van Krieken, MD, PhD and Professor of Tumor Pathology at Nijmegen Centre for Molecular Life Sciences in the Netherlands.
The dual color assay is being recommended by national guidelines rather than single color tests, as both the gene and 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 the HER2 CISH pharmDx™ Kit, test slides can be stored for reevaluation at a later point in time.
"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 shows there is 97.7 percent concordance between HER2 CISH pharmDx™ and a HER2 FISH test. 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 has received the CE-IVD label. It is available as of today in Europe, Canada and a number of other countries.
About the 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 bright field microscopes. HER2 CISH pharmDx™ Kits are indicated to aid the assessment of patients for whom Herceptin™ treatment is being considered. In a fraction of patients (25-30%) with breast cancer, the HER2 gene is amplified.
Herceptin® was rationally developed to specifically target HER2-positive breast cancers. Demonstration of high HER2 overexpression or gene amplification is essential for treatment with Herceptin™. Clinical studies(1) have shown that breast cancer patients whose tumors have high HER2 receptor overexpression and/or amplification benefit most from Herceptin®.
About pharmacodiagnostics testing and personalized medicine
Pharmacodiagnostic testing is performed in order to determine whether or not a patient is likely to respond to a given treatment. This testing is a prerequisite for the implementation of personalized medicine.
The idea behind personalized medicine is that identification of the individual's biological characteristics makes it possible to determine whether the patient will respond to drug treatments or not. In some cases this can be determined by a blood test, but in most cases sophisticated protein or gene tests such as those from Dako are required.
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
(1) Piccart-Gebhart MJ, Procter M, Leyland-Jones B, Goldhirsch A, et al., Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. NEJM 2005 Oct 20; 353:1659-72
