The Daily Sign-Out

Digital pathology article in "CAP Today"

Dr. Keith Kaplan at Digital Pathology Blog pointed this one out as a good article discussing the recent FDA meeting regarding whole-slide imaging (WSI) technology.  And he has some informed insights quoted in the article.  The online version of CAP Today has been out and I (again) urge you to check it out--although the hard copy version is probably sitting on your desk somewhere.

I reckon that you're take on this article might depend on your reaction to the quote from Ole Eichhorn ot Aperio:

"Eichhorn believes that the FDA fears that if it doesn't "get out in front" of digital pathology, there could be a proliferation of non-cleared/non-approved WSI systems "because these devices are useful and valuable.  By the way, that's what we have with the microscope"."(my emphasis)

If a device is already "useful and valuable" (as judged by me, a practicing pathologist or as judged by the marketplace of laboratories and pathologists), shouldn't the FDA just let us use these for making our diagnoses--like we already do with microscopes?  As in golf (with a similar governing body deciding what is allowable equipment and what is not), it's not the club, it's the player that makes the shot and records the score.  If I'm a crap player (okay, I admit it), it won't matter whether I have an approved or non-approved club, ball, grip-warmer, etc.--I'll still be a crap player!  The imager and software is NOT making the diagnosis, the pathologist is!  And I'll freely admit that the instrument/software might (sorry, I'd still like proof) be better at counting stainable events at statistically important cut-offs or at least doing it faster.  BUT I would also submit that whether a breast cancer is positive for ER at 21.38% or 25% to 50%, the clinician is going to look at my Allred score to determine treatment (sorry, Keith, that's where I slightly disagree with your statement as it is in the article).  The "precision" offered by these instruments for this use is a little disingenuous and adds a patina of "scientificity" that really isn't that clinically meaningful.

If the FDA wants to collaborate with CAP and industry groups to provide guidance on how we should validate these instruments in our own labs, I'm definitely on board with that. 

I think too that you really have to also keep in mind the various people at the table and ask what their own vested interests are in this process--not that I'm cynical or anything, but still. 

It seems that the CAP has taken a reasonable position, as articulated by Dr. Valenstein, but I would like to review the actual consensus position--which I cannot find on our (the CAP) website.  Can anyone else?  We really need real pathologists out there expressing their opinions on this stuff to the CAP and to these regulatory agencies.

Very cool post from Dr. Kaplan at Digital Pathology Blog regarding MEDTING.

Thoughts on the CAP Futurescape 2009 Digital imaging workshop

Thanks to CAP for putting together this workshop in conjunction with digital pathology company leaders Bioimagene and Aperio!  It was money and time well-spent and I encourage readers to consider attending next year's conference.

I thought that the Aperio exhibit/demonstration was more in the spirit of a workshop and felt that it provided a better appreciation of how one might use their scanning hardware and Spectrum software system in daily practice.

In contrast, the Bioimagene "workshop" was not really a workshop in the sense of a practical demonstration of their system, VIrtuoso.  Although I didn't find it as helpful in directly comparing the two systems,I think their target audience were pathologists new to the applications of digital pathology and not yet at the level of actually using digital pathology in practice.  Nevertheless, the individual presentations were very good (especially my colleague's, Dr. Shriram Jakate!).

I'm definitely considering attending the "Pathology Visions" conference in September.