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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.

Learn More About Our Multiomics Platform

 

 

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.​

  • 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.​​

Biomarker discovery to commercialization process

 

 

Dynamic Expertise in Companion Diagnostics

DNA + RNA + Protein CDx Icon

Expertise Spanning Platforms, Sample Types, Analytes, and Diseases

Harness our technologies that unlock challenging regions of DNA and RNA with streamlined, multiplex workflows.

  • Complex single nucleotide variants

  • Pseudogene discrimination

  • Gene conversions

  • 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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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: 

  • Are secreted by all living cells and number in the billions per milliliter. 

  • Contain content reflective of the cell of origin allowing for non-invasive collection rather than tissue-only biopsy. 

  • Are a stable sample amenable to frozen storage from CSF, plasma, or other biofluid. 

  • Enables multiomic analysis of gene expression biomarkers, DNA variants (e.g. splice variants, fusions), and proteins to increase assay sensitivity

 

 

CDx Demonstrated Track Record of Success

 

 

ExoLution Plus Asuragen Packaging

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

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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:

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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

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

CDx Media to Text Brain

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.

CDx Exosome

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.

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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

Learn more about the use of exosomes as a diagnostic tool with a non-invasive and highly sensitive method for detecting cancer-specific biomarkers. Bio-Techne’s proprietary intellectual property related to exosomes allows us to streamline CDx services, from biomarker discovery to commercialization. 

 

 

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.

Companion Diagnostics Focus

 

 

 

 

Contact Us to Accelerate Your CDx Development Journey