Collaboration to Validate and Develop New Oncology Biomarker Tests

Affymetrix, Inc has announced a research collaboration and licensing agreement with Massachusetts General Hospital (MGH) to co-develop new cancer biomarker tests using the Affymetrix’ QuantiGene® ViewRNA Assay platform, an in situ hybridization assay capable of single transcript in single-cell detection. As part of this 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 has 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, Gene Expression Business Unit Manager – Panomics at Affymetrix.

Currently, those who practice surgical pathology and cytology face challenges in the management of a broad range of cancers. Medical practitioners are optimistic that a solution to these challenges will be found in new biomarkers and drug targets which are being rapidly discovered by NGS and microarray technologies. Yet these new biomarker discoveries have in themselves become a challenge requiring extensive validation prior to becoming candidates for translation into diagnostic, prognostic, and predictive tests to fulfill the promise of delivering a new generation of personalized medicine and associated economic and healthcare outcomes.

"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,” said Daniel A. Haber, MD, PhD, director of the MGH Cancer Center. “This collaboration with Affymetrix aims to move this important work forward."

MGH is a world leader in cancer research and education, translational medicine, and a major center for patient care. MGH has some of the world’s largest annotated tissue banks for retrospective biomarker studies as well as large and diverse patient populations for prospective studies. MGH’s Cancer Center and Department of Pathology are currently collaborating with Affymetrix to validate biomarkers of current and future clinical importance using Affymetrix’ QuantiGene ViewRNA technology platform for multiplex in situ testing of FFPE tissue biopsies, FNA cytologies, and CTC “liquid biopsies”. QuantiGene ViewRNA is an ideal platform for cancer biomarker validation and testing as RNA is a predictable, sensitive and specific alternative to antibody based IHC and ICC testing. QuantiGene ViewRNA probes for RNA assays can be developed for research applications for any expressed gene within days and can analyze non-coding RNAs believed to be important master regulators of cancer and for which antibody assays can’t be developed. To date, the research collaboration has produced several potential diagnostic/prognostic biomarker targets including new class of non-coding RNA, HSATII, and EGFR vIII.