CDx Development Partnerships & Services
Bio-Techne offers precision medicine services to pharma partners spanning the continuum from biomarker discovery to post-market commercialization of companion diagnostic (CDx) products.
Bio-Techne takes 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.
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.
Multiomic Analysis Platform
Bio-Techne’s multiomics platform provides a comprehensive view of disease by combining genomic data with data from other modalities, including transcriptomics, epigenomics, and proteomics. This approach enables a multifaceted understanding of the molecular changes contributing to disease, allowing researchers to connect genotypes to phenotypes and discover novel drug targets and biomarkers.
Your Partner from Biomarker Discovery to Commercialization
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.
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Multiple CAP-accredited CLIA-certified labs: Supporting clinical testing needs
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Kitting & Manufacturing: We offer kit development as well as cGMP manufacturing in our FDA-registered ISO 13485 facility.
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Global Presence: Commercial reach in over 50 countries, over 200 labs are active users.
Dynamic Expertise in Companion Diagnostics
Expertise Spanning Platforms, Sample Types, Analytes, and Diseases
Expertise Spanning Platforms, Sample Types, Analytes, and Diseases
Harness our technologies that unlock challenging regions of DNA and RNA with streamlined, multiplex workflows.
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Complex single nucleotide variants
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Pseudogene discrimination
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Gene conversions
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Methylation
Tap into our extensive portfolio of industry leading proteins, antibodies, and immunoassays with fit-for-purpose development and validation to eliminate commercial barriers and ensures long-term supply continuity.
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Automated Simple Western and Simple Plex ELISAs
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Olink® Target 96 Gold-certified service provider
Exosome Isolation & Analysis
Exosome Isolation & Analysis
Stratify response to therapies and potential for segmentation in patient populations or understand therapy resistance leveraging our exosome-based platform.
Exosomes are powerful diagnostic tools because they:
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Are secreted by all living cells and number in the billions per milliliter.
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Contain content reflective of the cell of origin allowing for non-invasive collection rather than tissue-only biopsy.
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Are a stable sample amenable to frozen storage from CSF, plasma, or other biofluid.
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Enables multiomic analysis of gene expression biomarkers, DNA variants (e.g. splice variants, fusions), and proteins to increase assay sensitivity
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 for Companion Diagnostics
Complex Molecular Genetic Testing Made Simple
Complex Molecular Genetic Testing Made Simple
Asuragen, a Bio-Techne brand's AmplideX® testing technology accelerates the journey from Clinical Trial Assay (CTA) to Companion Diagnostics (CDx) by reliably amplifying GC-rich and other repetitive DNA sequences to develop treatments for specific gene types. This accomplishment is shown through partnerships such as:
- Wave Life Sciences and Asuragen’s development of a CTA targeting the HTT gene
- Zynerba and Asuragen’s partnership in the RECONNECT Trial for Fragile X Syndrome
Accelerating the Drug Development Journey
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 CTA needs.
Exosome Isolation for Biomarker Discovery in Companion Diagnostics
Exosome Isolation for Biomarker Discovery in Companion Diagnostics
Exosomes can be integrated into your therapeutic development journey from translational biomarker discovery through downstream development of clinical trial assays and CDx products.
Partner from Discovery to Commercialization
Biomarker Discovery & Diagnostics for Neurological Diseases
Biomarker Discovery & Diagnostics for Neurological Diseases
As exosomes pass through the blood-brain barrier, exosome-based diagnostics are likely to have considerable impact in Alzheimer’s and Parkinson’s diseases and other neurological conditions with high unmet need.
Beyond cfDNA: Harnessing the Power of Exosomes for Improved Sensitivity
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.
Partnership with Wave Life Sciences
Partnership with Wave Life Sciences
Asuragen, a Bio-Techne brand, entered a partnership with Wave Life Sciences for the development and commercialization of companion diagnostics for Wave’s investigational allele-selective therapeutic programs targeting Huntington’s disease (HD).
Video Library
Next-Generation Liquid Biopsies: Exosomes in Cancer Diagnostic Applications
Companion Diagnostics & IVD Development
Companion diagnostic tests can be used to identify patients most likely to respond to a therapeutic drug or biologic, as well as patients at lower or higher risk for a particular side effect. A CDx assay can also be used to monitor response to treatment with a particular therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness.
At Bio-Techne, our partnership model is different as we built capabilities and competencies to support partnering with you from concept to commercialization. This approach enables you to engage an IVD partner early in a stage-gated approach that ensures that when you are ready to accelerate, we as a partner already have the foundation that allows us to execute rapidly on a companion Dx and match the pace of your drug.