Bio-Techne at World CDx Europe | April 8-10, 2025 | Novotel London West | London, UK
Visit with us in the exhibition hall to learn how Bio-Techne can be your partner from discovery to commercialization.
Bio-Techne offers precision medicine services to pharma partners spanning the continuum from biomarker discovery to post-market commercialization of companion diagnostic (CDx) products. We take a unique, platform-agnostic approach to biomarker discovery and fit-for-purpose assay development. Our readiness for clinical trial sample testing in on-site CLIA labs, combined with diagnostic kit manufacturing and international regulatory expertise, enables us to provide customizable solutions for the global market.
Our expertise in CDx Development allows our pharma partners to enhance the likelihood of their drug's success and expedite the delivery of novel treatments to the patients who stand to benefit the most.
Ensuring Global Patient Care: Evaluating Strategies for CDx Development and Regulatory Approvals in Precision Medicine Programs
Presenter: Mary Anne Williams
Senior Director, Regulatory Affairs
- Developing effective biomarker strategies: technical and platform considerations
- Navigating regulatory changes and achieving compliance with IVDR
- Strategic commercial considerations for emerging market access
Wednesday, April 9th | 2:55 PM GMT
International Distribution of Kitted Products
We have 11 kits on the market, including products with FDA clearance, CE-IVD, Australian and Korean labeling.
- Commercial reach in over 50 countries, over 200 labs are active users
- cGMP manufacturing in our FDA registered ISO 13485 facility
- Technical support and scientific affairs team
- International field application support
Additional Resources
Beyond cfDNA: Harnessing the Power of Exosomes for Improved Sensitivity
Blood-based liquid biopsies are making inroads in cancer management and are increasingly used in conjunction with tissue biopsies. Plasma cfDNA, ctDNA and exoRNA can be used to molecularly profile cancer patients and guide downstream treatment decisions.
Accelerating the Drug Development Journey
The QuantideX® technology can be adapted to monitor disease burden in diseases requiring highly sensitive detection and/or quantitation across multiple nucleic acid targets. It can also be utilized for designing high performing, efficient, and simplified kits for genetic targets with unmet biomarker development and clinical trial assay (CTA) needs.
New Assay Offers Sensitive, Rapid, Noninvasive Classification of Gliomas
- Robust isolation protocol allows for analysis of extracellular vesicle RNA from blood samples.
- In adults, the most common type of abnormal growth in the central nervous system is glioma.
- In this study, scientists developed a blood-based assay from which they analyzed extracellular vesicle RNA found in just 2 mL of plasma. The assay incorporates droplet digital PCR for detection of the IDH1.R132H mutation. Using EV RNA instead of DNA as a target allowed the assay to achieve sensitivity of 75% and specificity of nearly 89%. The entire workflow takes less than four hours from the time a sample is collected.
Dynamic Neuronal Exosomal Biomarkers in Cell Culture Medium
Multiple partnerships with Exosome Diagnostics, a Bio-Techne brand, highlights capabilities for exosome approaches to support characterization through cell culture of progenitor cells and differentiated cells. Studies are broadly applicable across research areas but specifically showcase capabilities of exosomal RNA as dynamic biomarkers in neuronal progenitors and differentiated cells.
Meet With Us to Accelerate Your Journey!
For more information and registration details, please visit the World CB & CDx Summit Europe website.