Exosome Diagnostics, the developer of the leading liquid biopsy platform that enables non-invasive diagnosis of disease states, aiming to obviate the need for tissue biopsies, has announced its “Academic Bench to Clinical Diagnostics” (A to D) Assay Commercialization Program. The “A to D” program will provide academic and clinical researchers a means for bringing their biomarkers and assays to the clinical laboratory, while simultaneously utilizing the experience of the Exosome Diagnostics team to navigate the regulatory approval, reimbursement, commercialization, and business development processes. Researchers are developing novel biomarkers and assays with the company’s patented exosome isolation and RNA extraction technology using the exoRNeasy research kits marketed by QIAGEN. The exoRNeasy kit enables a convenient, robust, and high-yield isolation of exosomal RNA from blood. Under this “A to D” program researchers will now be able to bring their assays to Exosome Diagnostics for further validation by leveraging the company’s expertise in exosome isolation and analysis and development on the company’s proprietary clinical testing platforms, ExoLution™ for RNA-based biomarkers and assays, and ExoLutionPlus™ for the addition of cell-free DNA (cfDNA) for increased sensitivity of rare mutations when necessary. The ExoLution platforms have been developed and will be manufactured under cGMP to enable the exosome biomarkers to be extracted for clinical use, and are only available directly through Exosome Diagnostics. Simultaneously, the Regulatory Affairs team at Exosome Diagnostics will work with the appropriate regulatory agencies worldwide to ensure the fastest route for diagnostics approval.
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