Agilent Technologies Inc. (NYSE: A) today announced the expansion of Visiopharm’s validated image analysis algorithm to incorporate HercepTest™ mAb pharmDx for Dako Omnis, both CE-IVD marked and recently released for sale in Europe. This development enables pathologists to use the Visiopharm HER2 APP for objective decision support in the assessment of HercepTestTM mAb pharmDx stained slides, saving valuable time for both pathologists and patients.
The HercepTest™ mAb pharmDx assay is intended for breast cancer patients where Herceptin® treatment is being considered. HercepTest™ mAb pharmDx (Dako Omnis) includes a rabbit monoclonal antibody that provides robust and reproducible staining of the cancer biomarker, Human Epidermal Growth Factor Receptor 2 (HER2) in breast cancer tissue. If HER2 is over-expressed, the patient may be a candidate for Herceptin® treatment, which targets HER2 in the cancer cell.
Visiopharm’s HER2 APP uses automated image analysis to reproducibly assess and score HER2 staining in brightfield digital images of breast cancer tissue sections. The APP provides objective decision support to pathologists, who would traditionally only visually review slides under a microscope. This decision support reduces the number of inconclusive readings and therefore saves the pathologist time, and helps to provide a faster, more accurate diagnosis for the patient.
Dirk Vossen, Chief Diagnostics Officer of Visiopharm commented “The HER2 APP delivers objective, reproducible diagnostic decision support that enables pathologists to quickly and accurately review staining results. We are delighted that the algorithm is now validated for HercepTest™ mAb pharmDx for Dako Omnis.”
Furthermore, the addition of HercepTest™ mAb pharmDx assay to the Dako Omnis menu means that pathology labs can further benefit from patient case management with Dako Omnis, which helps them improve case delivery times and provide consistent, precise results for patients.
“Together, the HercepTest™ mAb pharmDx for Dako Omnis and Visiopharm’s HER2 APP represents an exciting step forward in our shared commitment towards improving end-to-end standardization in tissue diagnostics, enabling our customers to quickly and efficiently generate accurate diagnoses,” remarked Simon Østergaard, Agilent vice president and general manager of the company’s pathology group.
For in vitro diagnostic use in Europe.
HercepTestTM mAb pharmDx (Dako Omnis) (Code GE001):
The licensed antibody is created by Epitomics Inc. (an Abcam company), using Abcam’s proprietary rabbit monoclonal antibody technology covered under Patent No’s 5,675,063 and 7,402,409.
HercepTest™ and Herceptin® are trademarks owned by Genentech, Inc.