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KREATECH Diagnostics, ORIDIS Biomarkers go FISH
AMSTERDAM, The Netherlands—KREATECH Diagnostics and ORIDIS Biomarkers have entered into an agreement for the co-development and commercialization of oncology-related DNA-FISH assays.
According to Sandor Snoeijers, Kreatech's business development officer, "Kreatech and Oridis have bundled their core competencies because Kreatech's expertise to develop and manufacture customized REPEAT-FREE (RF) DNA-FISH probes and Oridis' ability to access vast biobanks, combined with their expertise as a highly valued CRO in clinical testing, will result in high-quality RF DNA-FISH assays optimized and validated on a statistical significant number of patient samples, providing the end-users with a tremendous head start in their clinical research."
FISH has already become well established in a number of indications, and the application of FISH in pathology is expected to continue to grow in the future with a focus on personalized medicine.
ORIDIS Biomarkers is a contract research organization specializing in cancer research, designing and performing retrospective and prospective custom-made tissue and body fluid studies, integrating clinical data and molecular pathology analysis.
"By combining Kreatech's expertise in producing high-quality probes with our experience in clinical assay development, we have created the perfect partnership. We are very excited by the prospect for follow-up products, and regard this collaboration as the start of a promising product pipeline," says Oridis CEO Burkhard Feurstein.
"We expect the demand for the molecular characterization of tumors will strongly increase for the coming years," Snoeijers adds. "With the current speed of discovering new biomarkers, we think opportunities will grow rapidly for this collaboration in the oncology segment."
Kreatech will design, develop and manufacture the RF FISH assays. Oridis will validate and optimize these assays on patient material. In addition, Oridis will play an active part in the identification of new biomarkers that allow detection by a DNA-FISH assay. The aim is to address the growing demand for companion diagnostic assays required throughout the preclinical and clinical development of new pharmaceutical compounds.
The first co-developed assay is designed to detect amplification of the fibroblast growth factor receptor 1 (FGFR1) gene. Amplification of FGFR1 has been observed in several cancer types including lung, breast, prostate and bladder cancer, and inhibition of FGFR1 has been highlighted as a promising goal for target-focused therapeutic intervention. In lung cancer, FGFR1 amplification is observed in approximately 20 percent of patients. The assay, which is currently being tested on clinical samples, is designed to identify such patients.
The official launch of the FGFR1 amplification test will be at the European Congress of Pathology in September in Prague. The test will be marketed via two channels, Snoeijers states, "via our current sales infrastructure, directly in EU countries and the U.S., and by our worldwide distributors elsewhere. End users will be mainly in the research and pathology segments. We will also use a key account approach, selling direct to pharma companies that are developing FGFR1 inhibitors, which might use the assay for preclinical and stratification purposes."
"As a dedicated global DNA-FISH provider I'm very pleased about the partnering with ORIDIS Biomarkers," says Kreatech CEO Kees Moonen. "By using Oridis' expertise in clinical testing and its access to extensive biobanks, we have the opportunity to bring our customized FISH program to the next level by offering tailor-made REPEAT-FREE DNA-FISH assays based on the customer's requirements and demands. With this collaboration we are able to contribute to successful clinical development of novel pharmaceutical compounds, as well as to the development of companion diagnostics."