OMNYX Digital Pathology System Nearing FDA Approval
By Christine Kern, contributing writer
Approval could bring cancer diagnosis into the 21st century.
The Digital Pathology Association (DPA) is urging digital pathology manufacturers interested in marketing whole slide imaging (WSI) devices for primary diagnosis to submit do novo applications to the Food and Drug Administration (FDA). Currently, there are no existing FDA-approved digital pathology systems for clinical use, according to the Pittsburgh Business Times.
The global digital pathology market is expected to expand to $492.8 million by 2020, according to a Transparency Market Research report.
Omnyx, founded in 2008 by a partnership between GE Healthcare and the University of Pittsburgh Medical Center (UPMC), filed for FDA-approval of their system in 2014, at which time it was classified as a Class III device with the highest risk classification. But clarification on the FDA classification process is encouraging the application and approval process.
As the DPA explained, the FDA had never formally classified WSI devices, allowing manufacturers to submit de novo applications for moderate or low risk devices which have 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 then become classified as a Class II device.
“The DPA is now comfortable suggesting that a manufacturer submit a de novo application based on discussions with the FDA, in which the FDA indicated the WSI for primary diagnosis is a candidate for de novo applications as a Class II device. Once a de novo application receives marketing authorization, other companies will then be able to submit 510(k)s for WSI,” the DPA statement read.
“The possibility that WSI for primary diagnosis could become a Class II device is a significant step forward for the industry,” said Michael Montalto, PhD, Sr. Vice President of Clinical and Medical Affairs for Omnyx. Montalto, who has chaired the DPA regulatory taskforce since 2013, added, “The FDA has been very open and responsive and has given the DPA clear guidance on classification and associated special controls.”
This is good news for Omnyx, which plans to move forward with the application for FDA approval. Advantages of the digital system include a faster diagnosis, easier delivery of digital images, and the development of advanced image analysis tools providing more individual treatment plans.
Omnyx CEO Mamar Gelaye told the Pittsburgh Business Times the system enables digital images to be sent quickly to specialized pathologists for diagnoses. She also said system development was delayed by reliance on low-power cameras that lacked the sufficient image resolution required. Now, with improved technology, the company already has products clinically approved in several other countries, including Europe and the Middle East.