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Companion Diagnostics Partnerships & Services

Bio-Techne offers precision medicine services to pharma partners spanning the continuum from biomarker discovery to post-market commercialization of companion diagnostic 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. 

This 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.

Our CDx services are integrated with a powerful Multiomics Platform, which combines transcriptomics, epigenomics, and proteomics to provide a comprehensive view of disease.

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Biomarker Discovery

  • Bioinformatics expertise to discover multiomic signatures with clinical utility
  • Specialized expertise as a leader in Exosome-based R&D
  • Proprietary chemistries for difficult repetitive and other structural variants
  • Innovative technologies for spatial biology and automated protein-based discovery and detection
  • Available in a wide variety of biofluids and solid tissues
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Clinical Trial Assay Development and Support

  • Development and validation of biomarker assays for clinical use
  • Diagnostic systems comprising reagents and assay analysis software built for the most stringent regulatory requirements
  • Development and commercialization of robust products with high quality, reduced complexity, and optimized workflow
  • Development and validation for: PK/PD, target engagement, proof-of-mechanism, dose selection, patient stratification, and primary and secondary endpoints. 
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Regulatory Support and Manufacturing

  • Multiple CLIA lab sites to support global testing needs
  • Experienced regulatory team to support a broad range of submissions, including 510(k) and PMA
  • Products registered in countries around the world
  • Commercial reach in over 50 countries for diagnostic kits distribution, with over 200 active lab users
  • cGMP manufacturing in our FDA registered ISO 13485 facility
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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

Dynamic Expertise in Companion Diagnostics

Spanning Platforms, Sample Types, Analytes, and Diseases

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Ability to Unlock Challenging Regions of DNA

Asuragen, a Bio-Techne brand, has an extensive history in the development of highly sensitive assays for regions of DNA that are challenging to sequence.  

Our proprietary chemistries can detect and analyze these targets with unprecedented ease. Capabilities extend to:

  • Complex single nucleotide variants
  • Pseudogene discrimination
  • Gene conversions
  • Methylation
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Expertise Spanning Oncology and Beyond

Bio-Techne has partnered with pharma companies to provide precision medicine solutions across a wide range of disease areas, such as:

  • Neurodegenerative diseases
  • Cancer and immuno-oncology
  • Rare and complex genetic diseases
  • Autoimmune diseases
  • Genitourinary diseases
  • Infectious diseases
CDx Demonstrated Track Record of Success in Clinical Trial Assay Development

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 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

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Improving Diagnostic Methods: Early Disease Detection in Alzheimer's

In another collaboration, Bio-Techne experts worked with researchers running a clinical study of Alzheimer’s disease where key genotype data was needed to evaluate patients and predict their near-term risk of developing cognitive symptoms.

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As Targeted Therapies Expand Beyond Cancer, Companion Diagnostics...

When scientist originally debated the merits of sequencing the entire human genome, proponents argued that genomic data would potentially allow for more precise targeting of therapies to patients. Today, treatments tied to specific genomic variants – and the companion diagnostics needed to identify people with those variants – have transformed patient care.

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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. 

Contact Us to Accelerate Your CDx Journey