New Multiplex Tissue Biomarker Service Launched to Advance Companion Diagnostics Development in a Regulated Environment

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Digital pathology services leader Flagship Biosciences announces the launch of a novel approach for quantitative measurement of multiple tissue biomarkers called FACTS (Feature Analysis on Consecutive Tissue Sections).

FACTS utilizes special histology stains and image registration techniques from radiology

FACTS enables a multiplexed analysis of protein expression on a technology platform that can be validated in a similar fashion to the many IHC digital imaging clearances already on the market. This is extremely important for late-stage oncology trials.

Flagship Biosciences announced today the launch of a new tissue biomarker multiplexing analytical tool for tumors and other tissues. The patent pending technique is based on advanced image registration approaches in radiology fields and applied to consecutive histology sections. The novel technology approach will be presented at Pathology Visions 2010 in San Diego. Flagship is currently offering the multiplexing technology as part of their digital pathology services.

The technique, known as FACTS (Feature Analysis on Consecutive Tissue Sections), expands the number of IHC markers that can be measured cost-effectively and reproducibly in oncology clinical trials and translational medicine. Multiple biomarkers are measured in aligned tissue sections, preserving morphology while not changing well-established histology and immunohistochemistry practices. The multiplexing approach is designed for use in GLP or CLIA regulated environments, as it improves standardization of immunohistochemistry and offers a complete audit trail of the glass and digital slide.

“In oncology drug development, there is an urgent need for more standardization of pathologist reading of immunohistochemistry, especially with companion diagnostic development and in clinical trials. In the development of FACTS, we worked backwards from the needs in CLIA regulated IHC laboratories to what could be developed for improving pathologist workflows on multiple tissue biomarkers,” said David Young, President and Chief Pathologist of Flagship Biosciences. “We can now efficiently and reliably measure specifically designated tissue regions for protein expression on 4-8 different IHC biomarkers on consecutive tissue sections. By separating stains with color deconvolution and using image registration approaches from radiology, we can offer clients a more reproducible IHC measurement without compromising established histology technologies.”

“There is a strong and immediate need for increased standardization of anatomic pathology in oncology clinical trials, and digital pathology is an important step in this direction. FACTS is a second exciting step that brings digital pathology capabilities to a new level,” said David Eberhard, Director of Clinical Trials Pathology Services at LabCorp’s Center for Molecular Biology and Pathology and Adjunct Associate Professor at the University of North Carolina. “FACTS enables a multiplexed analysis of protein expression on a technology platform that can be validated in a similar fashion to the many IHC digital imaging clearances already on the market. This is extremely important for late-stage oncology trials.”

In addition to the use of FACTS in regulated oncology clinical trials, there are also time-saving applications for the technology in preclinical GLP toxicology and biomarker expression analysis in research environments. “Pharmaceutical discovery groups demand as many protein expression profiles as possible in tissues. FACTS is a major improvement over existing IHC approaches, and is a great match for human xenograft tumor profiling,” said Neal Goodwin, Program Director of Jackson Labs Cancer Services.

About Flagship Biosciences

Flagship Biosciences is a pathologist-owned company whose mission is to deliver digital pathology services in pharmaceutical and medical device development. Flagship’s services include tissue biomarker development on-demand, low-cost digital pathology slide scanning, secure hosting, pathologist-supervised IHC and histology placement, and custom image analysis and companion diagnostics services. All of their services are reviewed and supervised by board-certified pathologists.

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