Nearly everyone agrees that digital imaging will play a big role in pathology in the future. Academic medical centers, commercial labs and large independent pathology labs are rapidly installing digital pathology systems. But its use in reimbursable clinical diagnostics is currently limited. Twenty-two percent of pathology groups and labs currently have a digital imaging system in place, according to LE’s Digital Pathology Trends Survey conducted in June. Ten-percent plan to add a system within 12 months and another 10% within the next 12-to-24 months.
Today, education and training is the most common use for labs using digital pathology. The biggest barrier to more clinical use is the cost of scanning digital slides, which don’t eliminate the need to first prepare glass slides. Among surveyed labs using digital pathology, 72% are using it for education and/or training, according to LE’s Digital Pathology Trends Survey. Sixty-three percent use it for second opinions and/or consultations, and 62% for quantitative immunohistochemistry for HER2 scoring. In terms of market share, 44% of digital pathology users have an Aperio system; BioImagene has a 16% share; Ventana, 9%; and Olympus, 8%. Other vendors have a combined 23% share, including Nikon, Leica Microsystems and Dmetrix.
More than half of surveyed labs without digital pathology cited “too expensive” as a barrier to adoption. Another 36% said traditional pathology/microscope works fine and 23% had LIS integration concerns. Only 15% said digital pathology systems were too slow and only 3% had concerns about image resolution. Meanwhile, Amanda Lowe, principal of Digital Pathology Consultants...believes the limited menu of FDA-cleared tests is a bigger issue than our survey suggests. “There’s no doubt that if the FDA would ‘gold stamp’ digital pathology on the clinical diagnostic end, it would help significantly,” she says.
In an email to me, Jondavid Klipp, the founder and editor of Laboratory Economics provides additional information about this trend: Roughly 500 commercial labs, pathology groups and academic medical centers have a digital pathology system/scanner in place. Digital pathology utilization for clinical diagnostics in United States is extremely limited, currently less than 1% of all slides.
One of the drivers for adoption of digital pathology by veterinary pathologists, emphasized by Steve Potts in his guest blogs, was that many of them work for pharmaceutical companies. They are thus heavily involved in drug toxicology studies as part of basic research studies and clinical trials. In such settings, global image networks have been established by these companies for sharing and storing animal and human whole slide tissue images. It is thus readily apparent that a far more convincing business case can be made for the deployment of digital pathology systems in Big Pharma than can be made for a pathology group working in, say, a mid-size community hospital. Note the barriers to adoption cited by the pathologists above. Here's a quote from Steve's first note :
Nearly all of the top 15 pharmaceutical companies have completed multisite-integration with digital pathology. The result of such conversions is that a pathologist working in one location can access slides at any other one or participate in an informal peer review or pathology working group.