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Harnessing ISH and IHC
July 2012
by Jeffrey Bouley  |  Email the author


SANTA CLARA, Calif.—The end of May saw Affymetrix Inc. and Wetzlar, Germany-based Leica Microsystems announce a worldwide collaboration to automate Affymetrix's QuantiGene ViewRNA ISH Tissue Assay on the Leica BOND RX staining platform, for research applications only at this point and not diagnostic procedures.  
The partners say this team-up will provide researchers "with a powerful automated everyday solution for drug discovery, translational research and the development of new companion diagnostic tests for personalized medicine by significantly reducing assay time for single-copy RNA in-situ hybridization (ISH) analysis."  
George Bers, vice president and general manager of the Expression Business Unit-Panomics at Affymetrix, expressed excitement in the news release about the deal, because he says the partnership with Leica "unlocks the true potential of single-copy RNA analysis, and we believe it will accelerate the discovery of important new drugs and the validation of novel companion tests."  
This is the first time the two companies have partnered up, Bers informs ddn, and talks began between the two about a year ago.  
"Leica has a world-class organization and rapidly growing automation and IHC [immunohistochemistry] business. Affymetrix has a world-class organization, a strong franchise in gene expression and rapidly growing RNA ISH business," Bers says. "Both companies have an entrepreneurial, development-driven culture and share the required capabilities and technologies to bring all of the new advances in translational medicine, molecular pathology and personalized medicine to the rapidly evolving advanced histostaining market segment."  
Bers adds that the industry is seeing increasing numbers of clinical trials, especially in oncology, that are being performed by pharma companies and collaborators in major medical centers, and he notes, "These trials are creating an increasing demand for translation of existing as well as newly discovered biomarkers for diagnostic, predictive, prognostic, risk assessment and treatment monitoring tests. Increased numbers of tests being run are driving demand for automation delivering higher throughput, reproducibility of results within and between labs and reduction of labor costs."  
That's where Affymetrix and Leica plan to come in, as the highly sensitive QuantiGene ViewRNA ISH Tissue Assay assists drug discovery and translation research by enabling researchers to measure RNA expression directly in a tissue section at single-copy sensitivity. Affymetrix boasts that more than 1,000 standard probes are already available and it only takes a few days to produce a customized probe for a new gene target. On the other side of the partnership, the Leica BOND RX system automates the staining process to provide consistency, reduced labor and speed. The companies maintain that this means researchers will have access to same-day assay completion and, with a standardized staining protocol, rapid setup for any probe.  
"While medical science has created powerful new treatments that greatly enhance lives, there are still many disease states where we need to discover better treatments, or even cures," noted Arnd Kaldowski, president of Leica Biosystems, in the news release about the deal. "We are proud that this collaboration with Affymetrix can help in the discovery and development process by enabling researchers to reduce both the time and cost of research so that new treatments can be made available to patients sooner."
Affymetrix's QuantiGene ViewRNA ISH Tissue Assay should be available for research applications in the third quarter of this year on the research-optimized Leica BOND RX platform. An optimized QuantiGene ViewRNA staining protocol will be preloaded onto the Leica BOND RX and a complete staining kit, including probes and all detection components, will be available from Affymetrix, which, as Bers notes, supplies RNA solutions to all stages of the drug discovery and development pipeline.  
"Clearly, the in-situ QuantiGene ViewRNA will be of greatest interest to preclinical safety and tox testing as well as clinical trials and companion diagnostics segments of pharma," Bers notes. "The in-vitro QuantiGene assays—the single-plex and multiplex versions—are of greater value for upstream processes, such as target validation and compound screening."  


Affymetrix, MGH to develop oncology biomarker tests  
SANTA CLARA, Calif.—On June 6, Affymetrix Inc. announced a research collaboration and licensing agreement with Massachusetts General Hospital (MGH) to co-develop new cancer biomarker tests using the Affymetrix's QuantiGene ViewRNA Assay platform, an in-situ hybridization assay capable of single transcript in single-cell detection. As part of the agreement, Affymetrix has the rights to commercialize the new biomarker tests as an outcome of this collaboration.  
"This agreement provides Affymetrix with an important opportunity to expand its QuantiGene ViewRNA Assay offering into the pathology and cancer research markets by providing new multiplex chromogenic in-situ hybridization (CISH) and fluorescence in-situ hybridization (FISH) RNA biomarker assays, which are validated on clinical samples for research applications. Advanced in-situ RNA hybridization methods applied to less invasive clinical samples such as FFPE core biopsies, FNAs, and CTCs have the potential of becoming powerful new tools to deliver diagnostics that enable the oncologist to personalize patient care," stated George Bers, vice president and general manager at Affymetrix.  
"The future of cancer treatment lies in our ability to precisely identify specific biomarkers so we can then find effective drugs for that particular form of disease," added Dr. Daniel A. Haber, director of the MGH Cancer Center. "This collaboration with Affymetrix aims to move this important work forward."  
Code: E071212



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