FDA clears Roche digital pathology platform for diagnosis

Roche’s move into the digital pathology category has been boosted by FDA approval of a lab instrument and toolkit for use as an aid to clinical diagnosis.

The clearance covers Roche’s Ventana DP 200 slide scanner, digital pathology workflow software, and a display that can be used to review and interpret digital images of scanned pathology slides.

Proponents of digital pathology technologies say that having this image data in an electronic format improves the efficiency of healthcare, making it easier to get second opinions and input from specialists, for example, regardless of where the patient is located. That becomes more important in areas where access to pathologists may be limited.

In some respects, the new approval is a key milestone for Roche, coming after years of effort at the diagnostics giant to build its presence in the digital pathology category. That dates back to its acquisition of Ventana Medical Systems more than 15 years ago and has been refined through alliances with partners like medical imaging company GE Healthcare and artificial intelligence specialist PathAI.

The latest development revolves around 510(k) approval of the Ventana DP 200 for clinical diagnosis, extending its use beyond research applications, and will help Roche mount a challenge to other players in the US digital pathology market, notably Philips with its IntelliSite platform and Leica/Sectra.

Roche’s strong position in the wider in vitro diagnostics market is expected to add traction to its efforts to expand in digital pathology. The company also recently introduced a new scanner – the Ventana DP 600 – that can handle a higher volume of slides.

“Primary diagnosis for digital pathology streamlines the digital workflow that empowers pathologists to make a timely diagnosis from anywhere,” said Jill German, head of the pathology lab business unit at Roche Diagnostics.

She added that Roche’s AI tools and open environment platform – which allows software developers to easily integrate their image analysis tools with its cloud-based Navify digital pathology platform and on-site uPath equivalent - are “designed to drive greater adoption and promote innovation in this critical field.”

According to market research firm Fortune Business Insights, the global digital pathology market was valued at just over $1 billion last year and is projected to grow to $1.15 billion in 2024 and $3.86 billion by 2032.

Digital pathology, meanwhile, is also helping to drive drug development in the biopharma industry. A survey published last year found that over 70% of major pharma companies and contract research organisations (CROs) have adopted digital pathology to advance drug R&D and accelerate the introduction of new therapeutics.