Harnessing ISH and IHC

Affymetrix and Leica collaborate on RNA in-situ hybridization tissue assay for research use

Jeffrey Bouley
SANTA CLARA, Calif.—The end of May saw Affymetrix Inc. andWetzlar, Germany-based Leica Microsystems announce a worldwide collaboration toautomate Affymetrix's QuantiGene ViewRNA ISH Tissue Assay on the Leica BOND RXstaining platform, for research applications only at this point and notdiagnostic procedures.
 
 
The partners say this team-up will provide researchers "witha powerful automated everyday solution for drug discovery, translationalresearch and the development of new companion diagnostic tests for personalizedmedicine by significantly reducing assay time for single-copy RNA in-situ hybridization (ISH) analysis."
 
 
George Bers, vice president and general manager of theExpression Business Unit-Panomics at Affymetrix, expressed excitement in thenews release about the deal, because he says the partnership with Leica"unlocks the true potential of single-copy RNA analysis, and we believe it willaccelerate the discovery of important new drugs and the validation of novelcompanion tests."
 
 
This is the first time the two companies have partnered up,Bers informs ddn, and talks beganbetween the two about a year ago.
 
 
"Leica has a world-class organization and rapidly growingautomation and IHC [immunohistochemistry] business. Affymetrix has aworld-class organization, a strong franchise in gene expression and rapidlygrowing RNA ISH business," Bers says. "Both companies have an entrepreneurial,development-driven culture and share the required capabilities and technologiesto bring all of the new advances in translational medicine, molecular pathologyand personalized medicine to the rapidly evolving advanced histostaining marketsegment."
 
 
Bers adds that the industry is seeing increasing numbers ofclinical trials, especially in oncology, that are being performed by pharmacompanies and collaborators in major medical centers, and he notes, "Thesetrials are creating an increasing demand for translation of existing as well asnewly discovered biomarkers for diagnostic, predictive, prognostic, riskassessment and treatment monitoring tests. Increased numbers of tests being runare driving demand for automation delivering higher throughput, reproducibilityof results within and between labs and reduction of labor costs."
 
 
That's where Affymetrix and Leica plan to come in, as thehighly sensitive QuantiGene ViewRNA ISH Tissue Assay assists drug discovery andtranslation research by enabling researchers to measure RNA expression directlyin a tissue section at single-copy sensitivity. Affymetrix boasts that morethan 1,000 standard probes are already available and it only takes a few daysto produce a customized probe for a new gene target. On the other side of thepartnership, the Leica BOND RX system automates the staining process to provideconsistency, reduced labor and speed. The companies maintain that this meansresearchers will have access to same-day assay completion and, with astandardized staining protocol, rapid setup for any probe.
 
 
"While medical science has created powerful new treatmentsthat greatly enhance lives, there are still many disease states where we needto discover better treatments, or even cures," noted Arnd Kaldowski, presidentof Leica Biosystems, in the news release about the deal. "We are proud thatthis collaboration with Affymetrix can help in the discovery and developmentprocess by enabling researchers to reduce both the time and cost of research sothat new treatments can be made available to patients sooner." 
 
Affymetrix's QuantiGene ViewRNA ISH Tissue Assay should beavailable for research applications in the third quarter of this year on theresearch-optimized Leica BOND RX platform. An optimized QuantiGene ViewRNAstaining protocol will be preloaded onto the Leica BOND RX and a completestaining kit, including probes and all detection components, will be availablefrom Affymetrix, which, as Bers notes, supplies RNA solutions to all stages of thedrug discovery and development pipeline.
 
 
"Clearly, the in-situQuantiGene ViewRNA will be of greatest interest to preclinical safety and toxtesting as well as clinical trials and companion diagnostics segments ofpharma," Bers notes. "The in-vitroQuantiGene assays—the single-plex and multiplex versions—are of greater valuefor upstream processes, such as target validation and compound screening."
 

 

 
Affymetrix, MGH todevelop oncology biomarker tests
 
 
SANTA CLARA, Calif.—On June 6, Affymetrix Inc. announced aresearch collaboration and licensing agreement with Massachusetts GeneralHospital (MGH) to co-develop new cancer biomarker tests using the Affymetrix'sQuantiGene ViewRNA Assay platform, an in-situhybridization assay capable of single transcript in single-cell detection. Aspart of the agreement, Affymetrix has the rights to commercialize the newbiomarker tests as an outcome of this collaboration.
 
 
"This agreement provides Affymetrix with an importantopportunity to expand its QuantiGene ViewRNA Assay offering into the pathologyand cancer research markets by providing new multiplex chromogenic in-situ hybridization (CISH) andfluorescence in-situ hybridization(FISH) RNA biomarker assays, which are validated on clinical samples forresearch applications. Advanced in-situRNA hybridization methods applied to less invasive clinical samples such asFFPE core biopsies, FNAs, and CTCs have the potential of becoming powerful newtools to deliver diagnostics that enable the oncologist to personalize patientcare," stated George Bers, vice president and general manager at Affymetrix.
 
 
"The future of cancer treatment lies in our ability toprecisely identify specific biomarkers so we can then find effective drugs forthat particular form of disease," added Dr. Daniel A. Haber, director of theMGH Cancer Center. "This collaboration with Affymetrix aims to move thisimportant work forward."
 
 
 

Jeffrey Bouley

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