Across the virtual pond

Flagship Biosciences and U.K.’s HistologiX to perform tissue-based companion diagnostic services in ‘virtual’ environment

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FLAGSTAFF, Ariz.—Digital pathology has opened a virtual window to the world of cells, enabling Flagship Biosciences LLC and Biocity, Nottingham, U.K.-based HistologiX to form a joint partnership aimed at providing histology services and tissue-based companion diagnostics development to European pharmaceutical clients.

The histology and slide scanning will be conducted by HistologiX in the U.K., the company announced Dec. 22. The slides will then be uploaded to a Flagship digital pathology secure server, where image analysis provides quantitation and pathology review can be conducted virtually.

Digital pathology is an image-based information environment enabled by computer technology that allows for the management of information generated from a digital slide. Digital pathology and quantitative immunohistochemistry (IHC) offer the ability for the image analysis and pathology review to be conducted remotely, and centralizes all data in a trial into a single location.

Tissue-based diagnostics is a major component in most oncology portfolios for companion diagnostics and depends on tissue procurement, outstanding IHC practices, image analysis and board-certified pathologist review.

Viewing virtual slides saves both time and money since geography is removed as a major logistics challenge, and the pathology analysis becomes both quantitative and can be reviewed by an expert pathologist in a study, and effectively communicated to pharmaceutical clients, Flagship says.

Steven Potts, Flagship's CEO, tells ddn this about the collaboration: "We actually were introduced by a top 10 pharmaceutical company in Britain, whom both Flagship and HistologiX were working with," Potts says. "They would send their histology locally, and we were working with them on image analysis and companion diagnostics. The client actually suggested that if the histology and scanning could be done locally, then the images could be analyzed for image analysis and pathology review from anywhere. The costs for shipping were so high, plus the geography time delays, that bringing these two companies together was critical."

As it is, each company complements the other, he adds.

"HistologiX is very strong in tissue-based laboratory services, from tissue procurement through histology and pathology reading," Potts says. "Flagship is strong in whole-slide scanning, image analysis and remote centralized reading of slides in a regulated environment. They fit extremely well together. Specifically, HistologiX handles the local histopathology and all tissue procurement, staining and slide preparation activities, followed by scanning of the slides. Flagship then holds the slides in our secure database and uses image analysis to provide quantitative readouts, followed by remote pathologist review."

The partnership "brings local histopathology together with global centralized digital repositories of slides and quantitative assessment of pathology scoring," he adds.

David Fairley, managing director of HistologiX, says that image analysis and quantitative IHC is a growing opportunity in oncology drug development, from early-stage research through clinical trials.
"Our partnership with Flagship Biosciences gives our clients virtual access, a centralized and standardized approach to slide review and a quantitative scoring approach that assists with pathology reads," Fairley says.

David Young, president of Flagship Biosciences, says the tissue-based companion diagnostics programs under development at pharmaceutical companies are far more complex than the currently approved biomarkers for breast cancer.

HistologiX brings "outstanding talent and experience" to the table, allowing Flagship to build quantitative IHC techniques on a strong GLP histology foundation, Young says.

Holger Lange, chief technology officer of Flagship Biosciences, says his team is working to define a regulatory approach to meet the needs of both the U.S. and European diagnostics approval processes. Potts explains, "Companion diagnostics development of tissue biomarkers requires three things—expert image analysis, pathology expertise and the ability to work with regulatory bodies in achieving widespread acceptance of new biomarkers and new technologies."

Lange has "demonstrated the ability to combine regulatory approval with novel image analysis technology," Potts says. "Holger and his team's achievement of five FDA clearances at Aperio in three years is unprecedented in digital pathology … and expands our ability to drive novel companion diagnostics—and particularly IVDMIAs—into clinical usage."

Lange is based in Germany in order to strengthen European alliances for Flagship Biosciences, and allow for more closely working with both U.S. Food and Drug Administration (FDA) and European Medical Agency (EMA) guidelines for late-stage companion diagnostics, Potts says.

Flagship Biosciences, with a data center in Flagstaff, Ariz., and a Boston-based digital pathology office, is a pathologist-owned company that delivers quantitative pathology to pharmaceutical and medical device clients.
HistologiX Ltd. is a GLP-accredited contract research organization providing commercial services to the pharmaceutical, biotechnology and academic/healthcare industries in histology, IHC, human tissue procurement, clinical trials, molecular biology and advisory consultancy. The company was formed in 2005 by experts in the field.

More recently, HistologiX has been increasing its service portfolio and has become involved in providing histology and IHC services for Phase I & II clinical trials.

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