Use of DICOM Images for Pathology Diagnostics Marks Significant Step towards Standardization

Digital pathology systems allow for the immediate and remote access to digital images of tissue samples, moving away from traditional physical glass slides that require microscope examination. The COVID-19 pandemic underscored the importance and utility of remote capabilities in pathology, significantly accelerating the adoption of digital pathology in the U.S. and boosting its market growth internationally.

Now, Sectra’s (Linköping, Sweden) digital pathology solution, along with Leica Biosystems’ (Nussloch, Germany) Aperio GT 450 DX, has received a 510(k) clearance by the US Food & Drug Administration (FDA). This marks the first FDA clearance within digital pathology that allows DICOM images to be used for pathology diagnostics and is a significant step towards standardization in this field. The Aperio GT 450, previously available under enforcement discretion due to the pandemic, is a well-established technology that delivers high-quality images at a fast turnaround time of less than 32 seconds per slide.

Leica Biosystems is not new to the regulated system market; the company boasts 25 years of experience in the digital pathology sector, where it has been integral in implementing, integrating, and innovating technologies that enhance cancer diagnosis and patient care. Sectra’s digital pathology solution is part of its broader enterprise imaging solution, designed to support a comprehensive approach to all imaging needs while reducing operational costs. This scalable and modular solution, centered around a versatile vendor-neutral archive (VNA), enables healthcare providers to grow from ology to ology and from enterprise to enterprise.

"There is no better time for laboratories to optimize their workflow with digital," said Naveen Chandra, Vice President and General Manager of Digital Pathology at Leica Biosystems. "Today, clinicians are faced with having to do more with less – digital pathology enables them to maintain a high standard of quality with world class images and a fast turnaround time, for the best patient care possible."

"Sectra has a strong track record of promoting and enabling open integrations and of pushing the development towards standardization within medical imaging IT. The recent FDA clearance including the clearance to utilize DICOM images for pathology diagnostics therefore makes me very proud,” said Dr. Torbjörn Kronander, CEO and President Sectra AB. “Due to the unique nature of the images used in digital pathology, proprietary formats have previously dominated. This FDA approval, including DICOM, shows that standardization is possible also within pathology. This is an important first step to a reality where healthcare providers can start reaping the benefits of a larger degree of freedom in choosing what hardware and software to combine, within pathology. This has the potential to increase workflow efficiency, facilitate the adoption of new technology and in the end—benefit patient care."