Netherlands-based healthcare and digital pathology company Royal Philips has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market its Her2/neu IHC Digital Manual Read product in the United States.
HercepTest is a test commonly used by pathologists in the assessment of treatment options for breast cancer patients, using conventional microscopy. The Philips Her2/neu IHC Digital Manual Read will enable them to assess HER2 status using a digital system and a computer monitor. Pathologists can now benefit from the digital imaging advancements for scoring HercepTest stained tumor tissue slides that are digitized by the Philips ultra-fast scanner, and made accessible through Philips advanced image viewing and analysis management system.
“Digitalization will continue to revolutionize healthcare by providing the right clinical information to the right caregiver at the right time,” says Perry van Rijsingen, General Manager of Philips Digital Pathology. “Clinical pathologists will now have direct access to the digitally stored Her2/neu IHC images to help them in the detection and semi-quantitative measurement of immunohistochemically (IHC) stained breast cancer tissue on their computer monitor.”
The Philips Her2/neu IHC Digital Manual Read is based on the Philips Digital Pathology Solution platform. This automated digital slide creation system was commercially introduced in Europe and Asia Pacific in 2012. Learn more about Philips digital pathology solutions.
