Dako Launches Fast HER2 ISH Assay for New Automated Staining Platform in Europe

20 octobre 2021 Pierre Perrin-Monlouis

Dako, an Agilent Technologies company and a worldwide provider of cancer diagnostics, 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.

About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a leader in chemical analysis, life sciences, diagnostics, electronics and communications. The company’s 20,600 employees serve customers in more than 100 countries. Agilent had revenues of $6.8 billion in fiscal 2013. Agilent acquired Dako in 2012, a well-known provider of reagents, instruments, software and expertise to make accurate diagnoses and determine the most effective treatment for cancer patients. Information about Agilent is available at www.agilent.com and information about Dako products is available at www.dako.com.

In September 2013, Agilent announced plans to separate into two publicly traded companies through a tax-free spinoff of its electronic measurement business. On Aug. 1, 2014, the company’s electronic measurement business began operating as Keysight Technologies, Inc., a wholly owned subsidiary. The separation is expected to be completed in early November 2014.

Forward-Looking Statements

This news release contains forward-looking statements as defined in the Securities Exchange Act of 1934 and is subject to the safe harbors created therein. The forward-looking statements contained herein include, but are not limited to, information regarding the separation of Agilent’s electronic measurement business; future revenues, earnings and profitability; the future demand for the company’s products and services; and customer expectations. These forward-looking statements involve risks and uncertainties that could cause Agilent’s results to differ materially from management’s current expectations. Such risks and uncertainties include, but are not limited to, unforeseen changes in the strength of our customers’ businesses; unforeseen changes in the demand for current and new products, technologies, and services; customer purchasing decisions and timing, and the risk that we are not able to realize the savings expected from integration and restructuring activities.

In addition, other risks that Agilent faces include those detailed in Agilent’s filings with the Securities and Exchange Commission, including our latest Form 10-K and Form 10-Q. Forward-looking statements are based on the beliefs and assumptions of Agilent’s management and on currently available information.

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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.
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.
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.

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