FDA clearance arms pathologists with digital technology to help assess treatment options for breast cancer patients
PITTSBURGH — April 14, 2014 — GE Healthcare and UPMC today announced that the Omnyx™ Manual Read of the Digital HER2 Application has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance will allow the OmnyxTM system to be marketed in the U.S. for this intended use. Omnyx, LLC is a joint venture of UPMC and GE Healthcare.
“With Omnyx, we are enabling pathologists to provide services to many locations without having to move either themselves or the glass slides, supporting their review and assessment of each patient,” said Mamar Gelaye, CEO, Omnyx. “Pathologists can now score HercepTest stained breast tumor tissue slides at locations separate from the laboratory processing the test, thus increasing access to shared expertise for more patients.”
The National Cancer Institute estimates 232,670 women will be diagnosed with breast cancer in 2014, and pathologists are the diagnosticians who definitively diagnose cancer. Yet, there is minimal focus on empowering pathologists with new digital technology. Supported by Omnyx, pathologists can now confidently use digital technology as an aid for the scoring of HercepTestTM stained breast tumor tissue slides, a test commonly used by pathologists in assessing treatment options for breast cancer patients.
Manual Read of the Digital HER2 Application is based on the Omnyx™ IDP system, which was commercially introduced in Europe and Canada in 2013.
The OmnyxTM Manual Read of the Digital HER2 Application on the OmnyxTM IDP System is intended for in vitro diagnostic use as an aid to pathology professionals for creating, managing, storing, annotating, measuring and viewing digital Whole Slide Images (WSI) from formalin-fixed, paraffin-embedded (FFPE) tissue sections stained with the Dako HercepTest. The system is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2/neu (c-erbB-2) in digital images of FFPE breast cancer tissue immunohistochemically stained with the Dako HercepTest™ and viewed on a computer monitor.
The Dako HercepTest is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered.
Omnyx is a trademark of Omnyx, LLC.
HercepTest™ and Herceptin® are trademarks owned by Genentech, Inc.
HercepTest™ is subject to an exclusive trademark license to Dako Denmark A/S.
About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter – great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.
About UPMC
A world-renowned health care provider and insurer, Pittsburgh-based UPMC is inventing new models of accountable, cost-effective, patient-centered care. It provides more than $887 million a year in benefits to its communities, including more care to the region’s most vulnerable citizens than any other health care institution. The largest nongovernmental employer in Pennsylvania, UPMC integrates more than 62,000 employees, 22 hospitals, 400 doctors’ offices and outpatient sites, a nearly 2.3-million-member health insurance division, and international and commercial operations. Affiliated with the University of Pittsburgh Schools of the Health Sciences, UPMC ranks No. 10 in the prestigious U.S. News & World Report annual Honor Roll of America’s Best Hospitals — and No. 1 in Pennsylvania. For more information, go to UPMC.com.
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