AMSTERDAM, The Netherlands—KREATECH Diagnostics and ORIDISBiomarkers have entered into an agreement for the co-development andcommercialization of oncology-related DNA-FISH assays.
According to Sandor Snoeijers, Kreatech's businessdevelopment officer, "Kreatech and Oridis have bundled their core competenciesbecause Kreatech's expertise to develop and manufacture customized REPEAT-FREE(RF) DNA-FISH probes and Oridis' ability to access vast biobanks, combined withtheir expertise as a highly valued CRO in clinical testing, will result inhigh-quality RF DNA-FISH assays optimized and validated on a statisticalsignificant number of patient samples, providing the end-users with a tremendous head start in their clinicalresearch."
FISH has already become well established in a number ofindications, and the application of FISH in pathology is expected to continueto grow in the future with a focus on personalized medicine.
ORIDIS Biomarkers is a contract research organizationspecializing in cancer research, designing and performing retrospective andprospective custom-made tissue and body fluid studies, integrating clinicaldata and molecular pathology analysis.
"By combining Kreatech's expertise in producing high-qualityprobes with our experience in clinical assay development, we have created theperfect partnership. We are very excited by the prospect for follow-upproducts, and regard this collaboration as the start of a promising productpipeline," says Oridis CEO Burkhard Feurstein.
"We expect the demand for the molecular characterization oftumors will strongly increase for the coming years," Snoeijers adds. "With thecurrent speed of discovering new biomarkers, we think opportunities will growrapidly for this collaboration in the oncology segment."
Kreatech will design, develop and manufacture the RF FISHassays. Oridis will validate and optimize these assays on patient material. Inaddition, Oridis will play an active part in the identification of newbiomarkers that allow detection by a DNA-FISH assay. The aim is to address thegrowing demand for companion diagnostic assays required throughout thepreclinical and clinical development of new pharmaceutical compounds.
The first co-developed assay is designed to detectamplification of the fibroblast growth factor receptor 1 (FGFR1) gene.Amplification of FGFR1 has been observed in several cancer types includinglung, breast, prostate and bladder cancer, and inhibition of FGFR1 has beenhighlighted as a promising goal for target-focused therapeutic intervention. Inlung cancer, FGFR1 amplification is observed in approximately 20 percent ofpatients. The assay, which is currently being tested on clinical samples, isdesigned to identify such patients.
The official launch of the FGFR1 amplification test will beat the European Congress of Pathology in September in Prague. The test will bemarketed via two channels, Snoeijers states, "via our current sales infrastructure,directly in EU countries and the U.S., and by our worldwide distributorselsewhere. End users will be mainly in the research and pathology segments. Wewill also use a key account approach, selling direct to pharma companies thatare developing FGFR1 inhibitors, which might use the assay for preclinical andstratification purposes."
"As a dedicated global DNA-FISH provider I'm very pleasedabout the partnering with ORIDIS Biomarkers," says Kreatech CEO Kees Moonen."By using Oridis' expertise in clinical testing and its access to extensivebiobanks, we have the opportunity to bring our customized FISH program to thenext level by offering tailor-made REPEAT-FREE DNA-FISH assays based on thecustomer's requirements and demands. With this collaboration we are able tocontribute to successful clinical development of novel pharmaceuticalcompounds, as well as to the development of companion diagnostics."
