Skip to main content

Bio-Techne Companion Diagnostics

Bio-Techne offers precision medicine services to pharma partners spanning the continuum from biomarker discovery to post-market commercialization of companion diagnostic products. Our platform-agnostic approach to biomarker discovery and clinical trial assay development, paired with clinical trial sample testing readiness at our CLIA labs and international regulatory expertise allows us to offer customizable solutions so that a pharma partner can improve their drug’s likelihood of success and deliver novel treatments to the patients most likely to benefit, faster.

CDx Discover Abstract Teaser Box


  • Bioinformatics expertise to discover 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

CDx Create Abstract Teaser Box


  • Development of biomarker signatures and validation 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
CDx Accelerate Abstract Teaser Box


  • Multiple CLIA labs 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, over 200 labs are active users
  • cGMP manufacturing in our FDA registered ISO 13485 facility

Dynamic Expertise

Spanning Platforms, Sample Types, Analytes, and Diseases

CDx DNA, RNA, Protein Equation

Multi-omic Approaches

We offer genomic and proteomic solutions across a broad range of discovery platforms. From NGS and PCR to automated protein based discovery and detection, we offer the breadth and depth of platforms and R&D expertise needed for comprehensive biomarker discovery programs.

Specialized Capabilities in Exosomes

Exosomes are a treasure trove of biomarkers to enable:

  • Analysis of DNA, RNA, and/or Protein
  • Profile the Entire Transcriptome with RNAseq
  • Complete Clinical Workflow Solution with cGMP Capabilities

Find out more about ExosDx’s Exosome Platform 

CDx Complex Molecular Testing

Ability to Unlock Challenging Regions of DNA

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

Our proprietary chemistries are able to detect and analyze these targets with unprecedented ease. Capabilities extend to: complex single nucleotide variants, pseudogene discrimination, gene conversions, methylation  


Learn more about the sensitive assays that are driving the evolution of precision medicine


Complex Molecular Testing Made Simple

Our kitted products have the ability to unlock biomarkers in a wide variety of biofluids and solid tissues. The kits feature all the necessary components – reagents, controls, and automated software – to deliver quality and accurate results in any laboratory around the world. 

Discover diagnostic tests that are robust, information rich, and easy-to­use for clinical diagnostic labs. 


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

Together Transforming Companion Diagnostics

CDx Media to Text Brain

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.

CDx Colorful DNA Teaser Box

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

When scientist originally debated the merits of sequencing an 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.

Electrophysiology Neuron Hero Image

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).

Expanding CDx Opportunities Beyond Cancer: Stratifying Huntington's Disease Patients

Our development efforts allowed pharma researchers to generate the biomarker information they needed from a single, streamlined diagnostic tool, replacing three tedious labor-intensive tests that were previously performed on three different technology platforms for each prospective patient.

The Next CDx Frontier: Developing Targeted Therapies for Complex Neurological Diseases

Learn how a biomarker-driven, diagnostics-enabled approach can facilitate the clinical, regulatory, and commercial success of drugs developed for neurodegenerative disorders.

Contact Us to Accelerate Your CDx Journey