Dark Report: Momentum Continues for Digital Pathology

The  most recent issue of the Dark Report* contains this nice article: Momentum Continues for Digital Pathology (PDF):

FDA clears reading of Aperio's digital progesterone receptor slides on computer monitor.

Last month, digital imaging in pathology gained additional momentum with the latest FDA clearance.  Aperio Technologies, Inc., now has FDA clearance to market its slide scanning system for reading digital progesterone receptor (PR) slides on a computer monitor.  Aperio plans to file an application next year with the FDA for clearance to use its digital pathology imaging system for the reading of digital H&E breast tissue slides on a computer monitor.

As the Dark Report notes, this was a significant clearance, following a similar clearance for reading Her2 slides on a computer monitor:

While Aperio is the first and only company to receive FDA clearance for a system that can be used for making diagnoses from digital slides for clinical use in pathology, these FDA clearances are important to the wider pathology community.  Each clearance establishes a precedent that makes it easier for other companies to submit digital pathology systems to the FDA and obtain clearance to market those systems for clinical applications.

And as noted, these IHC quantification clearances are stepping stones to filing for clearance for reading breast H&E slides digitally, the first true diagnosis performed with digital pathology technology.  I hope to be able to tell you more about that soon :)

* The Dark Report Intelligence Service is the leading source of useful information about the clinical laboratory industry and the profession of pathology.