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Capitalizing on 'Huge Sea Change,' Inspirata Seeks to Bridge Transition to Digital Pathology

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NEW YORK (360Dx) – With digital pathology technologies beginning to see improved clinical uptake, privately held Inspirata reported earlier this month the first-ever digital primary diagnosis of a suspected cancer case with support from the company.

According to Inspirata Chairman and CEO Satish Sanan, the development represents "a huge sea change" in pathology as the discipline moves from an analog to a digital workflow, and could provide a push to the digital pathology field, which has been viewed with some skepticism in the clinical space.

Following the primary diagnosis, the Tampa, Florida-based company also announced it had landed a $3.15 million grant from the National Institutes of Health to study head and neck cancer.  

Founded in 2014, Inspirata offers a software-as-a-service platform that automates the pathology workflow. Additionally, it provides diagnostic aids and decision support tools. According to Mark Lloyd, lead scientist, executive VP and company founder, the real value in digitizing whole-slide images is to augment and accelerate discoveries in genomics.

To that goal, Inspirata envisions its platform, known as a digital pathology cockpit, as a bridge to accelerate the transition to a digital workflow. The digital pathology cockpit primarily consists of three monitors for each pathologist that capture the pixel pipeline image of the patient sample and can access the library of images within and outside the medical center.

A pathologist can make only a limited number of analyses by looking at a slide, noted Lloyd. But once the whole-slide image is digitized, comparing the digital images creates the ability for multiple analyses, both of the individual slide and by cross-referencing other digital cancer images.

The digital transition already has taken place in radiology, said Lloyd and Clive Taylor, a professor of pathology at the University of Southern California Keck School of Medicine. In the future, "digital pathology and artificial intelligence [models] are destined to march hand in glove," said Taylor. The Inspirata model may be able to speed up adoption of digital pathology if it can demonstrate a good return to pathologists and labs on hardware and software costs, he added.

As part of its business model, Inspirata provides services, staff, and capital equipment to medical centers. In return the company is paid primarily for milestones achieved and service fees.

Inspirata is leveraging that model at the Ohio State University Comprehensive Cancer Center–Arthur G. James Cancer Hospital (OSUCCC-James), where Dr. Anil Parwani completed the first primary diagnosis of cancer using a digital pathology platform announced this month. According to the company, the diagnosis was the first time that digital pathology went beyond research use only in the US.

As part of the deal, Inspirata is paid on milestones and services provided for the first five years, after which the OSU cancer center has an option to buy the services or extend the contract for another five years. OSUCCC-James is Inspirata's first customer, and the company expects to secure more agreements with medical centers and researchers throughout the US, Europe, and Canada.

Inspirata and the OSU cancer center entered a 10-year agreement in 2016, and Inspirata is providing the hardware, software, and a 24/7 staff to support the transition of 50 pathologists to digital from analog diagnoses.

At the Ohio cancer center, Inspirata has installed eight Philips Intellisite Pathology Solutions, the only pixel pipeline device that is approved by the US Food and Drug Administration for a primary diagnosis. The Intellisite device includes an ultrafast pathology slide scanner, image management system, and display. The Intellisite findings are fed into Inspirata's digital cockpit platform, which is available to all 50 pathologists at OSUCCC-James.

The broad availability is expected to expand the use of digital images, according to Lloyd. At most US medical centers, if a pathologist decides to ask for a second reading by a peer, the image needs to be replicated and sent on. With the Inspirata digital cockpit, the images become available within the cancer center — and potentially many other cancer centers.

Inspirata continues to build a network of labs, software, and pathologists aimed at delivering digitized images more quickly to the pathologists for primary diagnosis, Lloyd said, adding the company is engaged in discussions to replicate the OSUCCC-James model at different US cancer centers, though he did not identify them.

Inspirata also believes it can expand its model more effectively outside the US through its acquisition of Omnyx from GE Healthcare in January. Omnyx, originally started as a joint venture between GE and the University of Pittsburgh Medical Center (UPMC), offered many of the same services as Inspirata, focusing on serving individual medical centers. But Omnyx also capitalized on GE's international network, which sold its flagship Dyamyx software in Canada and Europe. The Dynamax software is CE marked in Europe and licensed by Health Canada for in vitro diagnostic use.

The vision for combining Inspirata and Omnyx is for it to become a global diagnostic system for cancer, said Omnyx CEO Andrew Chomos. The most valuable technology applications in digital pathology will be the systems that can provide a more comprehensive diagnosis of cancer, and by combining with Inspirata and integrating their respective systems, Chomos said the two companies are filling the gaps in each company’s technology and moving toward the global diagnostic system.

Unlike in the US, Omnyx's customers in Canada and Europe are not limited to using only the Intellisite system. The Inspirata digital cockpit is scanner agnostic and, depending on a country's regulations, capable of integrating images from various digital pathology platforms, thus resulting in a more global diagnostic network.

Until systems other than the Intellisite are FDA approved, Inspirata will rely on the Philips device for use in US. The company, however, received a positive ruling from the FDA in March that its digital pathology cockpit is not considered a medical device and so is not subject to FDA approval or clearance.

The FDA ruling likely was based on Inspirata's use of the approved Intellisite pixel pipeline from the scanner, which ensures pathologists have a fully immersive cockpit, according to Inspirata. From the Intellisite, pathologists can access all relevant patient information, whole-slide images, and other resources to make a comprehensive and accurate diagnosis.

Accordingly, Inspirata anticipates building adoption of its system as more medical centers follow the lead of OSUCCC-James. The work by Dr. Parwani and his staff was validated by guidelines published by the College of American Pathologists (CAP) to ensure parity between the analog and digital modalities.

The OSUCCC-James pathologists diagnosed the same set of cancer cases twice — initially by ocular microscopy, which is the traditional way cancer and other diseases are diagnosed. Following a washout period, to assure pathologists did not recognize the tissue from ocular microscopy, the pathologists used the digital whole-slide images to render a diagnosis. The findings were then compared to affirm the digital reads were comparable to the microscopic reads.

The $3.15 million grant from the NIH/NCI is for research into head and neck cancer. The funds will enable a multidisciplinary team of cancer researchers at Case Western Reserve University (CWRU) in Cleveland to develop and validate an image-based risk predictor of aggressiveness in head and neck cancers based on digitized hematoxylin-eosin (H&E)-stained pathology images alone. The five-year grant with CWRU is in addition to $6.4 million in NIH/NCI R01 grants already awarded to Inspirata and CWRU over the last two years to develop digital pathology-based assays for breast and lung cancers.

The work with CWRU in breast cancer has combined panels of genes with the digitized H&E-stained pathology images. Lloyd said Inspirata and CWRU are seeking to finalize a trial with the FDA that will validate the breast cancer assays developed in partnership with CWRU.

Other than the grants, four private investors have provided all the funding for Inspirata since its founding, and Lloyd said the company is now revenue positive but is not yet operating at cash flow breakeven.

Sanan, a veteran healthcare technology entrepreneur who sold IT services outsourcing firm IMRGlobal for $438 million in 2001, teamed up with Lloyd about six years ago to lay the foundation for Inspirata.

Inspirata also is extending its reach to patient networks. Last October, the company hired Joshua Mann as vice president of the company's Cancer Information Data Trust (CIDT) program. The role seeks to align the CIDT business with Inspirata's systems design and data flow, spanning data collection, organization and management, as well as data analysis and visualization.