PITTSBURGH – Patients in the U.S. are now one step closer to having access to cancer diagnoses powered by the latest digital technology.
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This technology has the potential to help doctors deliver results more quickly and more precisely than the status quo.
Currently, pathologists render their diagnoses using slides and microscopes in much the same way that they have for the past 100 years. Digital pathology systems have been developed that allow pathologists to analyze and evaluate slide images on a computer, performing functions not possible using traditional slides and microscopes, which offers many potential advantages.
“Moreover, transitioning from glass to digital enables the development of next generation software tools, such as advanced image analysis and algorithms, as well as integration with molecular and genomic testing that can lead to more precise and individualized treatment plans.”
“Patients deserve the peace of mind that comes with knowing their doctors have made their diagnosis by utilizing all of the information available to them,” said Mamar Gelaye, CEO of Omnyx. “And, because cancer waits for no one, we have to act with a sense of urgency. Lives can depend on it.”
As a key member of the Digital Pathology Association (DPA) regulatory taskforce, Omnyx has worked collaboratively for the last several years with other manufacturers, pathologists, and the Food and Drug Administration (FDA) to review the current process for bringing this innovative technology to U.S. clinicians, which will ultimately benefit patients. In recent discussions, the FDA has indicated willingness to consider a less burdensome approval approach for digital whole slide imaging (WSI), without impacting safety or effectiveness.
“Digital pathology is a transformative technology that enables significant improvements in workflow and collaboration,” said George Michalopoulos, M.D., PhD, Chairman of the Department of Pathology at UPMC. “Moreover, transitioning from glass to digital enables the development of next generation software tools, such as advanced image analysis and algorithms, as well as integration with molecular and genomic testing that can lead to more precise and individualized treatment plans.”
The DPA recently issued a press release recommending that manufacturers of WSI devices submit de novo applications to the FDA for primary diagnosis in the US. Once one de novo application receives marketing authorization from the FDA, other companies will then be able to submit 510(k) applications for their WSI devices rather than submit and maintain the more lengthy and complex Premarket Approval (PMA) application.
Historically, the FDA has taken the position that since there are no equivalent FDA-cleared (i.e. predicate) devices, WSI devices used for primary diagnosis are high-risk, Class III medical devices. In order to legally sell a Class III device in the U.S. for use in primary diagnosis, manufacturers must obtain approval from the FDA by submitting through the lengthy and expensive PMA application process.
In 1997, the de novo classification option was established by law as an alternate pathway for bringing to market a moderate or low risk device which has not yet been classified, and for which there is no predicate device. If the FDA authorizes the marketing of a device based on a de novo application, the device will at that point become classified, in most cases as a lower-risk Class II device, subject to FDA 510(k) requirements.
“Omnyx applauds the DPA for its tireless efforts and acknowledges the FDA’s willingness to constructively engage with members of the digital pathology community on this important matter,” said Larry Kopyta Senior Vice President, Quality & Regulatory Affairs at Omnyx. “The de novo approach for WSI devices, when successful, will help bring this technology to patients more quickly, and spur additional innovation within the industry.”
Omnyx, LLC, a joint venture of GE Healthcare and the UPMC (University of Pittsburgh Medical Center), is helping to transform the way pathologists worldwide work and collaborate. Through our Precision Solution™ that includes smart scanners, brilliant software and transformative consulting, all members of the cancer care team can work together to enhance patient outcomes. Our vision is a world in which efficient and effective cancer diagnosis helps guide personalized patient care. Omnyx® products are for in vitro diagnostic use for specific clinical applications and are intended for research use only on other applications. For more information, visit www.Omnyx.com.
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. www.gehealthcare.com.
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 $888 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 60,000 employees, more than 20 hospitals, more than 500 doctors’ offices and outpatient sites, a 2.8-million-member health insurance division, and international and commercial operations. Affiliated with the University of Pittsburgh Schools of the Health Sciences, UPMC ranks No. 13 in the prestigious U.S. News & World Report annual Honor Roll of America’s Best Hospitals. For more information, go to UPMC.com.
Read more about Omnyx’s involvement with the DPA’s WSI regulatory efforts at Omnyx.com/blog or click here.
Lori Lukus, 412-894-2116