162 Days of Change

As of last Thursday, April 12, 2017 and going back to a rainy night in Cleveland on November 2, 2016, the past 162 days have seen at least 3 things most Americans, and perhaps many across the world thought they would never see happen in their lifetimes.

That rainy night in Cleveland started the clock with a 17-minute rain delay that ended a 108-year drought. Very expensive T-shirts all around Wrigley Field have been sold out that contain two simple words: It Happened.

Less than a week later, Donald J. Trump was elected as the 45^th President of the US of A.  Many late-night comedians and political satirists mused they wanted to see Mr. Trump run for President knowing he could never be elected.  It’s an interesting conundrum now. It happened.

And on April 12, 2017 the Food and Drug Administration (FDA), in charge of clearing medical devices (among other charges and duties), to support patient safety, provided clearance to Philips Intellisite Pathology System to claim their systems could be used for surgical pathology diagnoses.  It happened.

Now that it happened, one question is what took the FDA so long?

There are a lot of reasons if you think 10+ years, give or take, is a long time to ensure a new technology that can bring so many benefits, but not without some risk, required proper investigation and validation of claims by manufacturers.

If memory serves, the FDA started to have public meetings on the subject as early as 2009 outside of Washington, DC to begin to understand the role of color, pixels, monitor viewing of digital pathology images, pathologist user interaction and more over those 2 days. Certainly, before and since there have been several meetings, private and public, to try to help manufacturers understand what the FDA would require approving their claims for clinical use for primary diagnosis. The Digital Pathology Association (DPA) brought together an industry-sponsored, pathologist-led organization who pulled their collective resources together to push this initiative. At the first DPA Board Meeting I attended as a pathologist member, this was the key discussion that all the industry representatives agreed was a common goal to ensure safe patient care with their devices.  Since that first DPA meeting, FDA representatives have presented at the DPA annual meeting, Pathology Visions. A regulatory committee was formed to drive these discussions further.

Meanwhile, there were many industry-sponsored clinical trials devised, completed, in some cases submitted and in some cases, rescinded after submission. Issues of the lack of a predicate device, measuring “accuracy” in surgical pathology, technical issues related to insuring all tissue on the slide is captured, storage requirements, network issues and more that would be required to insure the correct image and correct diagnosis needed to be addressed.

A couple of years ago the FDA published a list of technical requirements and guidelines that would be required for a submission regarding primary diagnosis.  This is just my sense, but I think both the FDA and the manufacturers, with their collective consultants and interested parties began to recognize for this to occur, the submission would have to be application based, rather than case based. Perhaps approval would be fine for brain tumors or breast cancers, but could be too narrow in terms of the broader field of anatomic/surgical pathology.  Conversely, vetting 50,000 surgical pathology diagnosis that could potentially be too broad, was unrealistic.

Then something else occurred that I think detracted attention from the issue of whole slide imaging (WSI) given the risk/benefit ratio for the FDA. It announced it may exercise its purview to regulate laboratory developed tests (LDTs). Companies that produce laboratory tests, particularly for molecular pathology, caught the attention of the FDA. Laboratories that may produce their own LDTs for clinical use, specific to their laboratories, is one issue. Companies that are the laboratory, was/remains an entirely different issue. The FDA, Association of Molecular Pathology (AMP), CAP, ASCP and others are tackling this issue now.

But I think it required the FDA to redirect resources away from WSI while it was looking at sales of LDTs.

Nonetheless, Philips announced last Fall that they had made a submission of their own. Clearance was expected within 18 months, perhaps as early as this Summer.

It happened.

For the Cubs, it took new ownership, a new culture, to improve the physical facilities, be good neighbors in Wrigleyville and goal to bring a World Series to the North side.  And a few guys named Tom, Theo, Joe, Anthony, Jake, Kris, Ben, Javier, Addison, Derrick, Miguel and more made it happen.

And the Cubs have set the bar high for the other 29 teams.

And Philips has set the standard as the first digital pathology manufacturer to have their systems approved for clinical use. Certainly, it is the hope of all of us fans and consumers that others will do the same.

Just don’t expect the FDA to give the team at Philips $70000 rings with 5.5 karats of diamonds.

More on what this means for industry and patients, pathologists and laboratories. Perhaps after another Cubs World Series this Fall on a rainy night somewhere.