Bio-Techne at World CB & CDx Summit | September 3-6 2024 | Westin Boston Seaport District | Boston, MA
Partnership from Discovery to Commercialization:
Bio-Techne delivers precision medicine solutions through validated assay development, a broad portfolio of quality protein analysis tools, multi-omics platforms with integrated bioinformatics, regulatory support, and more.
Join Us for Our Exclusive Presentation at World CDx 2024!
Discussion Covers:
- Technical and platform considerations when developing biomarker strategies
- Regulatory strategies in an evolving global landscape; an IVDR success story
- Commercial considerations for emerging market access
Wednesday, September 4th 2024 | 4:10 PM ET
Fit-for-Purpose Assay Development and Validation Solutions
Fit-for-Purpose Assay Development and Validation Solutions
- Expertise supporting: PK/PD, target engagement, proof-of-mechanism, dose selection, patient stratification, primary and secondary endpoints, and other assays
- Multiple CLIA lab sites to support clinical testing needs
Broad Portfolio of High-Quality Protein Analysis Tools
Broad Portfolio of High-Quality Protein Analysis Tools
- Superior quality R&D Systems antibodies and immunoassays, as well as fully automated Protein Simple instrumentation platforms
- In-house technologies eliminate licensing barriers for streamlined commercialization
Integrated Multi-Omics Liquid Biopsy Platform
Integrated Multi-Omics Liquid Biopsy Platform
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Leverage powerful bioinformatics and AI/ML capabilities for genomic, epigenomic, transcriptomic and proteomic analysis to support your biomarker strategy
Regulatory Support
Regulatory Support
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Established track record of regulatory engagement (FDA and international regulatory bodies) to support a broad range of filings, from Pre-Submissions to 510(k) and PMA
Trusted Partner for Exosome-based Biomarker Development
Numerous pharmaceutical and biotech companies have partnered with Bio-Techne to further their capabilities through the power of exosome isolation, genomic, and proteomic profiling. We have extensive intellectual property related to exosomes and pair it with multiple downstream analysis options and sample inputs to take a single partner from discovery to kitted products.
We offer a wide range of precision medicine services from discovery to validation and beyond.
Bio-Techne has an experienced regulatory team with a track record of FDA and international engagement to support a broad range of submissions, including 510(k), De Novo Requests, and PMA.
- Multiple CAP-accredited CLIA-certified labs: Supporting clinical testing needs
- Kitting & Manufacturing: We offer kit development as well as cGMP manufacturing in our FDA-registered ISO 13485 facility.
- Global Presence: Commercial reach in over 50 countries, over 200 labs are active users.
