Flagship Biosciences and Affymetrix Partner on RNA Image Analysis in Tissue

Westminster, CO — October 10, 2012 — Flagship Biosciences announced today the validation
of a novel whole slide image analysis algorithm utilized for evaluation of RNA
expression in histology tissue sections. The software is currently being
utilized by Flagship’s pathologists in service of pharmaceutical research
studies and the development of tissue-based companion diagnostics.

Application of in situ hybridization (ISH) techniques to evaluate
RNA products including messenger RNA and non-coding RNA, which are seen to be
important in gene regulation and includes micro RNA (miRNA), satellite RNA and
long non-coding RNA (lncRNA), is growing in value in the research community.
While these RNA techniques have lagged behind more widely available protein
evaluation in tissue using immunohistochemistry (IHC), recent improvements by
leading reagent suppliers like Affymetrix, Inc. with their QuantiGene®
ViewRNA
Assays* have made their usage more available and standardized. New developments
include multiplexed two-color approaches and automation of the technology on an
automated IHC
autostainer platform.

The interpretation of RNA ISH in tissue requires pathologist
oversight, and continues to improve as the technology becomes more widely
available and the histology further automated. Currently quantitation
strategies require a careful combination of expert pathologist evaluation and
customized image analysis approaches.

Flagship Biosciences has developed a
combined pattern recognition and cellular analysis algorithm to simplify and
standardize the identification of the regions of interest in relevant and
surrounding tissue and to also identify cells and the chromogenic expression
patterns of the various RNA products. The analysis identifies the cells of
interest and associates the ISH probe with individual cells. The individual ISH
dots are measured by number, size, intensity, or in a summary form more
familiar to pathological evaluations. This solves the problem of interpreting
the significance of the ISH dots and allows data reporting and evaluation more
consistent with customary pathological approaches. This approach is being
utilized in several of Flagship’s pharmaceutical companion diagnostics and
research programs.

“We
are excited to partner with Flagship Biosciences and contribute Affymetrix’ QuantiGene
ViewRNA Assays to Flagship’s suite of histopathology analysis services provided
to pharmaceutical clients looking to accelerate the development of new drugs
and companion diagnostic tests,” said George Bers, Vice President & General
Manager, Expression Business Unit – Panomics for Affymetrix.  “QuantiGene ViewRNA Assays enable detection
of RNA transcripts at single cell resolution in FFPE tissues, core biopsies,
and fine needle aspirates. It complements IHC tests where antibodies are not
available or inadequate. Furthermore, Flagship’s new RNA ISH image analysis
service provides a critical final step in the automation and standardization of
advanced histo-staining assays.”

“Evaluating RNA expression in the
localized tissue context is a valuable addition to many pharmaceutical
companion diagnostics and research programs,” said Dr. Steven Potts, CEO of
Flagship Biosciences. “When challenges exist in a particular IHC assay, or when
additional biology insights into mechanism are required, RNA can be highly
valuable, particularly when coupled with expert pathologist evaluation. While
the quantitation of RNA in situ is still in its infancy, our ability to combine
Flagship’s image analysis techniques with Affymetrix’ technology is a valuable
step in the right direction.”

About Flagship Biosciences

Flagship
Biosciences delivers quantitative histopathology services in pharma and device development. Backed by a
combined 60 years of pharmaceutical pathology experience, Flagship has a
world-class team of pathology, histology, cancer biology, image analysis and
regulatory experts.

* For
research use only. Not for use in diagnostic procedures. QuantiGene is a
trademark property of Affymetrix, Inc.