Ventana Medical Systems Inc

An interview with Philippe Nore, international business leader—digital pathology

Recently, CLP spoke with Philippe Nore, international business leader, digital pathology, at Ventana Medical Systems Inc, Tucson, Ariz, a member of the Roche Group, about its acquisition of digital pathology company BioImagene Inc, Sunnyvale, Calif. Headquartered in Basel, Switzerland, Roche is a leader in research-focused health care with a long history in in vitro diagnostics, tissue-based cancer diagnostics, and diabetes management.

CLP: Can you share some insight on Roche’s expansion into pathology, and, specifically, digital pathology? Why now, and why BioImagene?

Nore: The Ventana VIAS image analysis system, launched in 2005, was our first product in the emerging digital pathology space. In recent years, however, the market has been trending toward whole slide scanners, versus VIAS field of view image capture and analysis. Digital pathology technologies are rapidly gaining momentum as a proven and essential technology to the 21st-century pathology lab. The acquisition of BioImagene Inc will strengthen Ventana’s global leadership in the pathology market. With new digital pathology tools, we will be able to provide laboratories a complete, optimized solution for their pathology workflow. Digital pathology will be a key component to the Ventana Patient Focused Solution providing image capture, image analysis, image and information management, and telepathology tools.

This acquisition reflects our strategy of organic growth combined with targeted acquisitions in innovative, synergistic businesses—particularly in areas that complement and add to our strengths.

CLP: Can you comment on the recent growth in adoption of digital pathology systems, and do you see that trend continuing for the foreseeable future? In addition, what factors do you think are fostering that growth?

Nore: The practice of pathology and the pathologists workflow have not changed significantly in decades. Digital pathology tools provide opportunities to increase workflow efficiencies and pathologist productivity by decreasing turnaround time, increasing access to data and pathology images, and streamlining the process of consultations and telepathology.

The expansion, growth, and adoption of digital pathology tools to date has been led by the research, biopharma, and education markets. Broad use in the clinical lab markets is just entering a rapid growth phase as the technologies have matured and use cases expanded. We see the growth trend continuing and increasing over the next several years. There are critical shortages of pathologists in many parts of the world leading to decreased access to subspecialty expertise. Digital pathology tools will make sharing cases and images with subspecialty or global thought leaders easy and seamless, minimizing the effects of this shortage. Pathologists and labs are being asked to do more without increasing resources and digital pathology tools can bring a 10% to 20% gain in workflow efficiency, allowing the pathologist to sign out more cases or labs to increase volumes.

CLP: In addition to growth, what other trends do you see influencing the digital pathology space?

Nore: In addition to growth, we see two key influencers on adoption of digital pathology tools in the clinical lab market. The first is the influence that key pathology informatics opinion leaders will have as their tremendous body of work in the space is widely distributed. Meetings like the Pathology Informatics and Pathology Visions present a venue for these thought leaders to share their studies and experiences with implementing digital pathology tools for routine clinical applications.

The second key influencer is likely going to be regulatory body guidance to industry on what the regulatory pathway will be for digital pathology tools and instrumentation. The FDA currently requires 510(k) clearance for automated image analysis algorithms used as an aid to the pathologist. The level of regulatory requirements for additional digital pathology use cases (such as whole slide digital imaging systems for primary pathologic diagnosis) remains unclear. Regulatory guidance for industry will have an impact on adoption in clinical markets as pathologists and lab directors look for products that are either approved or cleared by their respective agencies.

CLP: What can BioImagene customers expect to see postintegration? Will the current product offerings remain fairly close to what is now available?

Nore: As with all of Ventana’s innovative pathology solutions, our digital pathology products will fully leverage our strengths in standardized and high-quality staining platforms, assays, and workflow solutions such as Vantage. BioImagene customers can expect access to the broader Ventana team of service and support as well as a product offering that will continue to improve testing efficiency in pathology laboratories and increase the standard of care for cancer patients worldwide.

CLP: What types of product line expansions do you have planned in digital pathology?

Nore: BioImagene has historically had a very proactive approach to R&D, product development, and new product launch based on customer and market needs. Our latest product offering, iScan Coreo Au scanner with Virtuoso software, was launched in March 2010 and is a best-in-class brightfield scanner. Prior to the acquisition, BioImagene announced future launch plans for the iScan Concerto scanner, which supports both brightfield and fluorescence scanning; the iSlide input device to ease a pathologist’s transition from manual to digital pathology; and the Crescendo pathology workstation. Ventana will communicate with customers and industry on the launch dates of these products at the appropriate time.

CLP: For those labs that might not have considered adoption of digital pathology or been undecided, can you expand on unique benefits and advantages?

Nore: Whole slide images that can be accessed anywhere and shared in seconds have many advantages over standard microscopy. A digital pathology infrastructure enables rapid consultations and multiple pathologist review of important cases. Cases, including frozen sections, can be reviewed from remote locations, allowing pathology practices to maximize efficiencies and minimize costs of pathologist staffing. Furthermore, digital images can be shared with nonpathology clinical colleagues, such as oncologists, to highlight important findings.

A digital slide is the springboard for a wide variety of digital pathology applications. Digital pathology will automate and redefine the standard of care.

Some examples of things you can do faster, better, or at a lower cost are: improve report turnaround time by eliminating the need to ship slides, improve the archiving and retrieval process, faster preparation for tumor boards, make remote case review possible, enable efficient primary diagnosis, reduce handling errors, increase slide availability, and improve quantification techniques.

Some examples of things that could not be done before digital pathology are: quantitative comparison, case sharing and collaboration, image analysis, remote frozen sections, data mining for decision support, and personalized medicine.

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Suzanne Clancy is editor of CLP.