Flagship Biosciences LLC, a quantitative pathology company and HistologiX, a GLP accredited CRO today announced a joint partnership to provide histology services and tissue-based companion diagnostics development to European pharmaceutical clients.
Tissue-based diagnostics is a major component in most oncology portfolios for companion diagnostics, and depends on tissue procurement, outstanding immunohistochemistry practices, image analysis, and board-certified pathologist review. The nature of most oncology clinical trials are global, so shipping glass slides and adequately supervising the histology and pathology can be a difficult logistics challenge.
Digital pathology and quantitative IHC offers the ability for the image analysis and pathology review to be conducted remotely, and centralizes all data in a trial into a single location. Flagship Biosciences is teaming with Histologix to offer this service to European pharmaceutical clients. The histology and slide scanning will be conducted by Histologix in the UK. The slides are then uploaded to a Flagship digital pathology secure server, where image analysis provides quantitation and pathology review can be conducted virtually. Geography is then 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.
“Image analysis and quantitative IHC is a growing opportunity in oncology drug development, from early stage research through clinical trials,” said David Fairley, Managing Director of Histologix, and a veteran in the management of tissue-based regulated diagnostic testing. “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.”
“It is clear than in most companion diagnostics programs, a 510k or PMA will be required for approval,” said Dr. Holger Lange, Chief Technology Officer of Flagship Biosciences, and who is based in Germany. “We are working to define a regulatory approach that will meet the needs of both US and European diagnostics approvals process in tissue. Flagship needed an expert partner in tissue handling and IHC methodology in Europe, as image analysis results are dependent on outstanding histology practices.”
“The tissue-based companion diagnostics programs that are under development at pharmaceutical companies are far more complex than the currently approved biomarkers for breast cancer,” said Dr. David Young, President of Flagship Biosciences, and a well-recognized leader in tissue-based companion diagnostics development. “Histologix brings outstanding talent and experience in tissue procurement, histology and immunohistochemistry procedures, and GLP and regulatory expertise. This competency allows Flagship to build quantitative IHC techniques for European clients on a strong GLP histology foundation.”
Flagship Biosciences LLC, with a datacenter in Flagstaff, Arizona and a Boston digital pathology office, is a pathologist-owned company that delivers quantitative pathology to pharmaceutical and medical device clients.
HistologiX Ltd is a rapidly growing GLP accredited Contract Research Organisation (CRO) providing commercial services to the Pharmaceutical, Biotechnology and Academic/Healthcare industries in Histology, Immunohistochemistry (IHC), Human Tissue Procurement, Clinical Trials, Molecular Biology and Advisory Consultancy. The Company was formed in 2005 by individuals with extensive experience in regulatory and non-regulatory diagnostic and clinical histology as well as IHC.