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New Automated Staining Platform in Europe

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Dako, an Agilent Technologies company, today announced the EU launch of HER2 IQFISH pharmDx™ automated on Dako Omnis.

The new product will enable pathology laboratories to easily integrate the renowned Dako HER2 IQFISH and IQFISH hybridization buffer into their IHC workflow. Dako Omnis is Agilent's newest pathology instrument that automates both IHC and ISH processes and enables entire patient cases to be processed simultaneously. The four-hour turnaround time for the IQFISH assay allows same-day return on diagnoses, a breakthrough that allows pathologists to make quick diagnoses and help oncologists provide treatment decisions for cancer patients. Pathology labs now have the option to simultaneously stain IHC and ISH slides, load by patient case, and process multiple FISH slides in just a few hours. HER2 IQFISH is the first of many probe launches to come in the near future on Dako Omnis, all of which will be in IQFISH quality.

"We are excited about this and the upcoming probe launches on Dako Omnis," said Jacob Thaysen, vice president and general manager for Agilent's Diagnostics and Genomics business. "We are committed to improving the speed and accuracy of patient-sample processing and the quality of test performance, because we know these things greatly affect the treatment decisions and outcome for patients."

HER2 IQFISH pharmDx™ is known for its nontoxic IQFISH Fast Hybridization Buffer that reduces diagnostic test turnaround time from 18 hours to less than four hours. The IQ Buffer also ensures brighter fluorescent signals with decreased background staining compared with traditional FISH assays1, 2.

As an aid in the treatment decision for gastric and breast cancer, HER2 IQFISH pharmDx™ can quantitatively determine HER2 gene amplification in the tumor, allowing oncologists to in turn prescribe potentially life-saving therapies. Nearly 1 million new cases of gastric cancer and more than 1.5 million new cases of breast cancer are diagnosed each year worldwide3.

1.    Pala, EE, Bayol U, Ozguzer A and Akman O (2013). “HER2 status in gastric cancer: A comparison of two novel in situ hybridization methods (IQ FISH and dual color SISH) and two immunohistochemistry methods (A0485 and HercepTest™).” Pathology - Research and Practice 209(9): 548-554.
2.    Franchet, C, Filleron T, Cayre A, Mounie E, Penault-Llorca F, Jacquemier J, Macgrogan G, Arnould L, Lacroix-Triki M (2013). “Instant-quality fluorescence in-situ hybridization as a new tool for HER2 testing in breast cancer: a comparative study.” Histopathology.
3.    Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray, F. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available from: http://globocan.iarc.fr, accessed on 24/January/2014.