Exciting news today from FDA with news of approval of first liquid biopsy test for use in non-small cell lung cancer.  The cobas EGFR test is already approved for use in formalin-fixed paraffin-embedded (FFPE) tissue. This new use is intended...

More interesting news around PD-L1 for use in Classical Hodgkin lymphoma with specific indications as below. Another increasingly common example of companion diagnostics and personalized immunotherapies. On May 17, 2016, the U.S. Food and Drug...

As many readers are aware, on April 20th the FDA released its Technical Guidance Document for Digital Pathology Whole Slide Imaging Devices after draft proposal/review from February of last year. Given its title, this is a technical...

WHAT DOES IT MEAN TO ME? The Digital Pathology Association 2016 Webinar Series – Session 2 Available to Members Only Thursday, May 25, 2016 | 1pm EST Learn more about the newly released FDA Guidance for Technical Performance Assessment of...

The featured post for today is guest written by Dr. Anil Parwani, known throughout the industry as a key opinion leader and has been very active in digital pathology among many other professional and research interests. In his post he looks...

The Digital Pathology Association (DPA) recently announced its suggestion that digital pathology manufacturers currently interested in marketing Whole Slide Imaging (WSI) devices for primary diagnosis in the United States submit de novo...