KLAS: State of Digital Pathology Among Early Adopters in 2022

What You Should Know:

– In anticipation, many technology vendors are vying for a foothold in the US, leading to a highly varied landscape. In partnership with the Digital Pathology Association (DPA), KLAS surveyed 55 provider organizations (including hospitals, health systems, academic health centers, and reference labs) to assess the state of digital pathology among pioneers in the US and determine which vendors are gaining traction.

– 33 of the interviewed organizations are live with digital pathology; the rest are currently implementing or making plans for the future.

Insight into US Digital Pathology 2022

Digital pathology for primary diagnosis is nascent in the US, but it is primed for rapid growth, similar to what is currently being seen in Europe. In anticipation, many technology vendors are vying for a foothold in the US, leading to a highly varied landscape. The insights identified from the report are as follows:

1. State of Digital Pathology among Early US Adopters: According to the survey, 64% of the organizations used Digital Pathology for primary diagnosis, 15% used it for non clinical cases, whereas 21% used it for other clinical uses cases, other than primary diagnosis. The report also found that from a sample of 33, all of the histology slides were read digitally, whereas 21% of the cytology slides were read, as opposed to 6% of the fluorescence slides.

– 13 of the interviewed organizations that are not yet live (including several large health systems) report plans to adopt digital pathology within the next two years, indicating a quickening trend toward broader market adoption. However, digital pathology still has ground to gain in the US before it reaches a tipping point. Larger organizations are more likely to see cost savings, thanks to economies of scale.

– 100% of respondents who have selected or are likely to select Leica Biosystems or Philips for their IMS offering report the same vendor as their selection or likely choice for a scanner. Leica’s scanner is also FDA approved for use with Sectra’s IMS, further bolstering Leica’s consideration and selection rates. Of the many additional scanner vendors that play in the market, Hamamatsu, Roche, and 3DHISTECH lead in mindshare and selections for pairings with third-party IMSs.

– The market for AI solutions in digital pathology is very early, and organizations are largely undecided as to which solutions they will choose—most solutions have yet to receive FDA approval for diagnostic use. The sole exception is the Paige Prostate solution from Paige. Visiopharm and Paige are the current mindshare leaders, though others such as PathAI and Ibex are close behind, indicating that the market is primed for a shake-up as diagnostic use expands.

– Challenges to adoption: Up-front and ongoing costs are the most frequently reported challenge when it comes to adopting digital pathology. There is little funding to help with adoption and no additional reimbursement to do things digitally. Since the conclusion of this survey, new CPT codes for slide digitization for primary diagnosis have been announced, indicating the potential for future cost mitigation with greater industry standardization.