NEW YORK (360Dx) – When Abhi Gholap now thinks about a company that he sold to Roche in 2010 for $100 million, he sees that the market may not have been quite ready for digital pathology at the time.
But seven years after selling that company called BioImagene, the space has evolved and where healthcare professionals once weren't quite sure about the advantages of using digital pathology technology, Gholap now sees an opportunity for on-demand, cloud-based digital services, he said in an interview.
Tapping into that need, he founded Optrascan in 2014 and last year the firm began offering a subscription-based service to pathologists who want access to digital pathology technology but don't want to pay the high instrument costs.
At a starting price of $1,000 per month, with additional fees for certain services, Optrascan provides digital pathology services based on its system, also called Optrascan, which enables the acquisition of whole-slide images (WSI) as well as viewing, sharing, on-demand analysis, and management of digital slides.
The system handles 15 to 120 slides using brightfield or fluorescent scanning technologies. Its on-demand solutions include a small footprint whole-slide imaging scanner; an integrated image viewer and image management system; telepathology; image analysis; and computer-aided region detection, as well as 10 terabytes of cloud storage per month.
Depending on the type of clinical or research work being done by the pathology group — whether it is evaluating breast, prostate, or brain tissue, for example — pathologists can select from a variety of tissue and assay libraries.
According to Gholap, a selling point of Optrascan's digital pathology solutions and services is that they are "significantly less expensive" than traditional digital pathology systems. With the on-demand solution, the cost to a pathologist is as little as $1 per slide. By comparison, pathology groups converting from traditional pathology to digital pathology may need to make an investment of up to $250,000 in capital equipment.
GE Healthcare, Leica Biosystems, Roche's Ventana Medical Systems, Philips Healthcare, and Hamamatsu Photonics, Apollo Enterprise Imaging, Xifin, Definiens, Visiopharm, Omnyx, and Corista are among the leading companies in the digital pathology market.
But, Gholap said, Optrascan is the only company offering on-demand digital pathology. "All other companies in the market focus on a capital sale with an average deal size from [$100,000 to $250,000]," he said. The cost is, therefore, "highly impossible for pathologists" who are used to purchasing conventional microscopes for $5,000 apiece. That's why less than 12 percent of the market has adopted digital pathology since the technology first appeared in early 2000, he added.
Globally, the digital pathology market was estimated at $384.3 million in 2016, according to research and consulting firm Markets and Markets.Â
Regulatory timeline
Optrascan's on-demand system is currently available in the US and Europe for research use only. Among its customers are the University of California, Los Angeles; the University of Southern California; the University of Texas; and National Cancer Institute. Optrascan is working to get clearance for its technology from the US Food and Drug Administration, which the firm expects to happen in about two to three months.
Optrascan said it also expects to get CE marking in Europe in the second quarter of this year.
Additionally, the firm anticipates making its technology available elsewhere — including South Africa, Brazil, and China — for clinical use. Gholap said that the Indian government is also promoting the use of Optrascan’s services to hospitals there.
In October 2016, Optrascan received a $5 million injection in Series A funding from Gholap and Patrick Soon-Shiong, the CEO of NantWorks, a network of health companies including NantOmics. Until then, Gholap had funded the company from its official inception in 2014.
The new funding will be used to accelerate the expansion of the company's product line, and to manufacture Optrascan Multispectral, Confocal, and Frozen tissue whole slide imaging scanners, and machine vision-based image analytics systems, NantOmics said.
Optrascan and NantWorks said that an augmented intelligence platform enabled by unsupervised machine learning and machine vision, developed by NantWorks and NantOmics, will be integrated with Optrascan pathology instruments and services to establish "intelligent pathology diagnostic tools in this era of immunotherapy in cancer, enabling the 2D and 3D identification of immune-effector and -suppressor cells."
“These integrated solutions will have the potential to maximize quality, quantity, and efficiency of pathology clinical capabilities and directly align with the Cancer MoonShot 2020 vision to accelerate next-generation personalized care for oncology patients," Soon-Shiong said in a statement.
Soon-Shiong, a billionaire surgeon, is a leader of the Cancer MoonShot 2020 program, now called Cancer Breakthroughs 2020, which he launched a year ago to aid in the development of vaccine-based immunotherapies for cancer. Shiong's initiative is separate from the cancer moonshot effort launched last year by former Vice President Joe Biden.
Soon-Shiong noted that the aim of the Optrascan, NantWorks, and NantOmics collaboration "is to integrate our whole genomics, transcriptomics, and proteomic analysis … with this next-generation pathology visualization machine enabling diagnosis of the immunome."
In a related development, NantWork companies NantHealth, NantKwest, and NantOmics announced in December the public availability of Quilt (Quantum Immuno-oncology Lifelong Trial) Programs, aimed to harness and orchestrate all elements of the immune system through the testing of treatment combinations, within the national clinical trials database, www.ClinicalTrials.gov.
NantOmics is developing an integrated approach to unearth the genomic and proteomic variances that initiate and drive cancer, by analyzing both normal and tumor cells from the same patient and following through on identified variances from DNA to RNA to protein to drug.
“Patrick’s goal of sharing information to advance cancer research and accelerate big science endeavors such as the Cancer MoonShot 2020 and QUILT program are in line with those of Optrascan, making this venture an ideal synergy between the two organizations," Gholap said in a statement in October.
Also, in December Optrascan announced a collaboration with Salesforce to create a laboratory information management system that is available to pathologists on demand for $65 per month. Implementing a laboratory information management system can be "a hassle for the pathologist" who would normally need to invest in servers and software for laboratory information management, Gholap said. The Optrascan solution, CloudPath, is part of the firm's digital pathology solutions suite. It is HIPAA compliant and launched on the Salesforce AppExchange business app store. Â
Market adoption
While capital costs are often cited as a barrier to adoption of digital pathology, there are others. Luke Perkocha, who practices anatomic and clinical pathology at Kaiser-Permanente in Northern California, wrote in a recent issue of The Pathologist that WSI requires a glass slide, so it does not remove the costs of slide-based pathology in the way that digital technology took out the cost of film in radiology. At the same time, switching to WSI brings the same hardware, software, and other information technology costs as converting to digital radiology.
He noted, nonetheless, that although "pathology and radiology aren’t equal," digital pathology does hold promise for image analysis and quality assessment.
Whole slide digital images have the potential to replace glass slides as the predominant viewing modality by pathologists for diagnostic purposes, wrote David Wilbur, a pathologist at Massachusetts General Hospital, and colleagues in the Journal of Pathology Informatics. They added that slide imaging has the potential to impart "very important improvements to workflow, cost, accuracy, and overall healthcare outcomes."