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Affymetrix, Leica Roll out Automated RNA In Situ Hybridization Assay Platform

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This article has been corrected from a previous version. Micah Litow's name and title have been corrected, and Affymetrix's relationship with Leica has been clarified.

NEW YORK (GenomeWeb) — Affymetrix recently announced the availability of its ViewRNA eZ assays on Leica Biosystems's fully automated Bond RX staining platform, a combined offering that the companies believe will appeal to pharmaceutical companies, translational researchers, and molecular diagnostics firms.

Affymetrix's ViewRNA in situ hybridization assays enable users to localize and visualize RNA in cells or tissues in singleplex or multiplex formats. But, while ViewRNA provides researchers with the ability to detect coding RNA as well as non-coding markers in formalin-fixed, paraffin-embedded tissues, among other sample materials, the assays had until the launch of the new combined offering always been manual or semi-automated, requiring significant hands-on time.

"By fully automating the ViewRNA eZ assays protocol, we now enable high-throughput slide processing, significantly reducing hands-on time, and improving assay reproducibility – including operator-to-operator and site-to-site reproducibility," Guy Afseth, Affymetrix's marketing director for clinical applications, told BioArray News this week.

"With an automated platform one can easily integrate the assay into current lab workflow and transfer the assay to other sites with minimal impact on staining quality," he added.

Affymetrix gained its ViewRNA in situ hybridization assays through its 2008 acquisition of Panomics. While microarrays continue to be the Santa Clara, Calif.-based vendor's flagship products, it has continued to innovate within the Panomics business, notably by launching QuantiGene FlowRNA, a flow cytometry-based assay that allows simultaneous measurement of gene and protein expression in a single cell, last year.

In 2012, Affymetrix announced its agreement with Leica to automate Affymetrix's ViewRNA assays on the Bond RX.

There are other companies, such as Life Technologies and Exiqon, that offer RNA in situ hybridization assays, and many of these assays, including Affymetrix's, can be run on tissue microarrays. According to Afseth, the availability of an automated platform could give Affymetrix an advantage in that market.

"Researchers have long understood the benefits of being able to visualize RNA in situ, especially in situations where other expression markers, such as [immunohistochemistry], were not suitable," he said. "However, up until now, all RNA ISH assays have been a manual or semi-automated procedure that required significant hands-on time," he said, noting that the new offering might find its mark among the company's target markets.

"Pharmaceutical and companion diagnostics companies, contract research organizations, and translational research labs will all find ViewRNA eZ assays to be a useful tool for biomarkers analysis and validation," he said, noting that the assays offer the possibility to easily visualize any messenger RNA, non-coding RNA, or genes for secreted proteins in FFPE samples, and is particularly useful when other biomarker assessment methodologies, such as IHC, are not suitable."

For Nussloch, Germany-based Leica Biosystems, the deal enables the company to offer its customers another research tool.

"We are proud to have put such a powerful tool into the hands of the dedicated researchers who are making important discoveries, increasing our knowledge and improving cancer diagnostics," Micah Litow, director of research and innovation for advanced staining instruments at Leica, said in a statement.

The company did not respond to an email seeking additional comments on the deal.

Leica provides automated protocols and instruments for use in anatomical pathology laboratories worldwide.

The company introduced the Bond RX three years ago and has since "gained significant market share across North America," and it recently was launched in Europe, Afseth said. The platform is commonly used by pharmaceutical companies, academic institutions, and CROs, he added.

Some Bond RX users have been attracted to the platform for its high throughput and flexibility. Will Howat, manager of the immunohistopathology core facility at the Cancer Research UK Cambridge Institute at the University of Cambridge in the UK, in a recent online review discussed his use of the Affymetrix assays and the Bond RX.

"In collaboration with Affymetrix, we have been evaluating an automated version of their manual branched DNA non-radioactive ISH method that was validated last year," Howat wrote. "This is designed to operate on the Leica Bond RX that was purchased earlier this year and will allow full automation of the ISH process including deparaffinization and pretreatment of the tissue sections," he wrote. "This will enable us to run 30 slides overnight, increasing the throughput of the facility, and increasing the ease of the [use] of ISH to the institute."

While Affymetrix and Leica will work together to promote and market the combined offering, each company will remain responsible for the sale of its own products. Afseth also stated that Affymetrix and Leica will continue working together in the future to expand the ViewRNA eZ portfolio for the Leica Bond RX platform.

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