Digital slides of patient tissue for pathologists' analysis are ready for the U.S. market. The FDA has issued its first clearance for a whole slide imaging system to enable the review and interpretation of digital surgical pathology slides prepared from biopsied tissue – for Royal Philips' Intellisite Pathology Solution.
The agency's decision on the Amsterdam-based company's product was based on one of the largest studies ever done of about 2,000 surgical pathology cases to compare digital pathology to optical microscopes. The FDA clearance includes special controls to ensure the system's precision, reliability and clinical relevance. The system has been marketed in Europe for primary diagnostic purposes since 2014.
"Once you have a digitized slide, you can move that image around. You can send it in for consultations for remote diagnosis. You can use all sorts of algorithms to analyze what is posted or to aid the pathologist in making better decisions, fast decisions working on these complex images," Russ Granzow, general manager of Philips Digital Pathology Solutions, told Medical Device Daily in an interview.
"So, it really enables the full gamut of what digitization brings to any industry. Pathology is the last bastion of medicine that's not been digitized, so it will drive the ability to improve workflow, to make it easier for images to be compared and contrasted with each other, sent for second opinions around the globe – as opposed to mailing glass slides around in boxes by FedEx, which is the standard today," he continued.
Added Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, "Because the system digitizes slides that would otherwise be stored in physical files, it also provides a streamlined slide storage and retrieval system that may ultimately help make critical health information available to pathologists, other health care professionals and patients faster."
Algorithms and machine learning analysis to offer insights into the digital slides aren't part of the cleared product – but they will be integrated into the Intellisite Pathology Solution in Europe starting as early as this year.
Philips has done a series of disclosed and undisclosed acquisitions as well as partnerships to enhance its capabilities on this front. These include a collaboration with Cambridge, Mass.-based PathAI Inc. to develop artificial intelligence technology for pathology that was announced last month. It aims to incorporate deep learning into computational pathology, with an initial focus on the automatic detection and quantification of cancerous lesions in breast cancer tissue.
"Digitization is a first step, but it's not the end goal. You need to digitize to do things that are exciting and important, so it's a requirement. But now it's about what we do with these images and how we make them useful," summed up Granzow.
Last June, Philips also said it would buy Belfast, Ireland-based Pathxl Ltd. and partner with Visiopharm with an eye toward continuing to advance its digital pathology offerings. Pathxl has image analysis and tissue pathology software, while Hoersholm, Denmark-based Visionpharm licensed to Philips its breast cancer software algorithms that are designed to aid pathologists in an objective diagnosis of breast cancer.
The aim of the latter is to offer more consistent reading and diagnosis, and this product already has a CE mark in Europe, making it a likely first candidate for the integration of algorithms into the Intellisite system in the EU.
MAKING THE CONNECTION
In addition to integrating sophisticated analytics, Philips is also working toward more easily integrating pathology information with other sorts of data to offer a more complete and accurate portrait of the patient that can enable better treatment guidance by the physician. Currently, that process relies upon physically assembling physician experts and all sorts of data to make a tough treatment call. But technology could make this much simpler, more routine and more productive.
"The ability to bring in other -ologies, whether it's genomic or radiology, all is part of the future of where this is going. It's very much driven by how the institutions bring those data together themselves," said Granzow. "If the hospital systems have a tumor board, they bring all those experts together and they take a very tough patient case and try to understand what treatment should be given. They sit around the table and look at a lot of different data sets and images to do that. And the tumor board is the first place where all these things will be brought together to bring better care."
He continued, "Our system is open to enable that; other systems that are out there starting to do it also. We are moving in that direction. That's part of the grand future vision of where health care is going to go – to get better, definitive diagnosis."
The transition to that integrated vision of patient data is likely to entail a significant investment and commitment to updating workflow for health care institutions. Completely digitizing the workflow of pathologists – trading in glass slides for digital ones – is expected to increase efficiency and security.
The data to support the FDA clearance was from 16 pathologists at four clinical sites, the Cleveland Clinic, University of Virginia, Miraca Life Sciences and Advanced Pathology Associates, where they conducted about 16,000 slide reads across 2,000 cases.
Philips also worked with the agency and the industry group Digital Pathology Association (DPA) to outline special controls to ensure the Intellisite system's precision, reliability and clinical relevance. This enabled the company to gain a de novo classification, a regulatory pathway for low- to moderate-risk medical devices that are the first of their kind, Granzow said.
"We have invested heavily to be the first on the market with a clinically cleared product for this space. It now really allows the industry to move forward and to bring to market products. The FDA is going to have a yardstick that we've developed with the FDA to measure the product. The device will be the de facto standard. But, it's important to get one product through the FDA, to have it cleared, and now we think it's a very good sign for the industry," Granzow concluded.